Trial Outcomes & Findings for Effectiveness of Screening and Brief Interventions for Alcohol and Tobacco During Breast Cancer Treatment (ONKODETOX) (NCT NCT03371732)
NCT ID: NCT03371732
Last Updated: 2022-12-02
Results Overview
Individual decrease of 20% in the AUDIT (Alcohol Use Disorders Identification Test) score observed at 3 months AUDIT test measures alcohol consumption and makes it possible to describe its profiles. Its score ranges from 0 (no consumption) to 28 (alcohol dependence).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
104 participants
Primary outcome timeframe
3 months
Results posted on
2022-12-02
Participant Flow
Participant milestones
| Measure |
Arm 1
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
53
|
|
Overall Study
COMPLETED
|
39
|
46
|
|
Overall Study
NOT COMPLETED
|
12
|
7
|
Reasons for withdrawal
| Measure |
Arm 1
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
3
|
|
Overall Study
Refusal to continue
|
3
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arm 1
n=51 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=53 Participants
Arm 2 : Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.8 years
STANDARD_DEVIATION 10.4 • n=51 Participants
|
48.0 years
STANDARD_DEVIATION 8.9 • n=53 Participants
|
48.4 years
STANDARD_DEVIATION 9.6 • n=104 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=51 Participants
|
53 Participants
n=53 Participants
|
104 Participants
n=104 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=51 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=104 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Current family situation
Single
|
4 Participants
n=51 Participants
|
6 Participants
n=53 Participants
|
10 Participants
n=104 Participants
|
|
Current family situation
In a couple
|
16 Participants
n=51 Participants
|
16 Participants
n=53 Participants
|
32 Participants
n=104 Participants
|
|
Current family situation
Married
|
21 Participants
n=51 Participants
|
25 Participants
n=53 Participants
|
46 Participants
n=104 Participants
|
|
Current family situation
Divorced
|
7 Participants
n=51 Participants
|
5 Participants
n=53 Participants
|
12 Participants
n=104 Participants
|
|
Current family situation
Widowed
|
3 Participants
n=51 Participants
|
1 Participants
n=53 Participants
|
4 Participants
n=104 Participants
|
|
Number of children
|
1.8 Child
STANDARD_DEVIATION 0.9 • n=51 Participants
|
1.8 Child
STANDARD_DEVIATION 1.0 • n=53 Participants
|
1.8 Child
STANDARD_DEVIATION 1.0 • n=104 Participants
|
|
Level of education
No diploma
|
2 Participants
n=51 Participants
|
1 Participants
n=53 Participants
|
3 Participants
n=104 Participants
|
|
Level of education
Below high school diploma
|
10 Participants
n=51 Participants
|
10 Participants
n=53 Participants
|
20 Participants
n=104 Participants
|
|
Level of education
High school diploma to bachelor's degree (included)
|
22 Participants
n=51 Participants
|
24 Participants
n=53 Participants
|
46 Participants
n=104 Participants
|
|
Level of education
Higher than bachelor's degree
|
17 Participants
n=51 Participants
|
18 Participants
n=53 Participants
|
35 Participants
n=104 Participants
|
|
Profession
Farmer-operators
|
0 Participants
n=51 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=104 Participants
|
|
Profession
Artisans, merchants and company director
|
0 Participants
n=51 Participants
|
2 Participants
n=53 Participants
|
2 Participants
n=104 Participants
|
|
Profession
Company's exécutives and higher intellectual profession
|
11 Participants
n=51 Participants
|
16 Participants
n=53 Participants
|
27 Participants
n=104 Participants
|
|
Profession
Intermediate professions
|
5 Participants
n=51 Participants
|
1 Participants
n=53 Participants
|
6 Participants
n=104 Participants
|
|
Profession
Employees
|
21 Participants
n=51 Participants
|
25 Participants
n=53 Participants
|
46 Participants
n=104 Participants
|
|
Profession
Labor
|
2 Participants
n=51 Participants
|
2 Participants
n=53 Participants
|
4 Participants
n=104 Participants
|
|
Profession
Pensioners
|
3 Participants
n=51 Participants
|
1 Participants
n=53 Participants
|
4 Participants
n=104 Participants
|
|
Profession
Economically inactive
|
9 Participants
n=51 Participants
|
6 Participants
n=53 Participants
|
15 Participants
n=104 Participants
|
|
Type of cancer
Canal carcinoma in situ
|
0 Participants
n=51 Participants
|
4 Participants
n=53 Participants
|
4 Participants
n=104 Participants
|
|
Type of cancer
Ductal carcinoma infiltrant
|
48 Participants
n=51 Participants
|
42 Participants
n=53 Participants
|
90 Participants
n=104 Participants
|
|
Type of cancer
Other
|
3 Participants
n=51 Participants
|
7 Participants
n=53 Participants
|
10 Participants
n=104 Participants
|
|
Tumor extension stage
Missing
|
4 Participants
n=51 Participants
|
3 Participants
n=53 Participants
|
7 Participants
n=104 Participants
|
|
Tumor extension stage
T0
|
1 Participants
n=51 Participants
|
2 Participants
n=53 Participants
|
3 Participants
n=104 Participants
|
|
Tumor extension stage
T1
|
9 Participants
n=51 Participants
|
11 Participants
n=53 Participants
|
20 Participants
n=104 Participants
|
|
Tumor extension stage
T2
|
23 Participants
n=51 Participants
|
21 Participants
n=53 Participants
|
44 Participants
n=104 Participants
|
|
Tumor extension stage
T3
|
13 Participants
n=51 Participants
|
13 Participants
n=53 Participants
|
26 Participants
n=104 Participants
|
|
Tumor extension stage
T4
|
1 Participants
n=51 Participants
|
3 Participants
n=53 Participants
|
4 Participants
n=104 Participants
|
|
Past treatment(s)
Surgery · No
|
36 Participants
n=51 Participants
|
31 Participants
n=53 Participants
|
67 Participants
n=104 Participants
|
|
Past treatment(s)
Surgery · Yes
|
15 Participants
n=51 Participants
|
22 Participants
n=53 Participants
|
37 Participants
n=104 Participants
|
|
Past treatment(s)
Chemotherapy · No
|
22 Participants
n=51 Participants
|
27 Participants
n=53 Participants
|
49 Participants
n=104 Participants
|
|
Past treatment(s)
Chemotherapy · Yes
|
29 Participants
n=51 Participants
|
26 Participants
n=53 Participants
|
55 Participants
n=104 Participants
|
|
Past treatment(s)
Radiotherapy · No
|
49 Participants
n=51 Participants
|
50 Participants
n=53 Participants
|
99 Participants
n=104 Participants
|
|
Past treatment(s)
Radiotherapy · Yes
|
2 Participants
n=51 Participants
|
3 Participants
n=53 Participants
|
5 Participants
n=104 Participants
|
|
Past treatment(s)
Hormonotherapy · No
|
47 Participants
n=51 Participants
|
51 Participants
n=53 Participants
|
98 Participants
n=104 Participants
|
|
Past treatment(s)
Hormonotherapy · Yes
|
4 Participants
n=51 Participants
|
2 Participants
n=53 Participants
|
6 Participants
n=104 Participants
|
|
Past treatment(s)
Without treatment · No
|
41 Participants
n=51 Participants
|
38 Participants
n=53 Participants
|
79 Participants
n=104 Participants
|
|
Past treatment(s)
Without treatment · Yes
|
10 Participants
n=51 Participants
|
15 Participants
n=53 Participants
|
25 Participants
n=104 Participants
|
|
Spouse's AUDIT-C score
|
3.6 scores on a scale
STANDARD_DEVIATION 2.6 • n=51 Participants
|
3.4 scores on a scale
STANDARD_DEVIATION 1.9 • n=53 Participants
|
3.5 scores on a scale
STANDARD_DEVIATION 2.2 • n=104 Participants
|
|
Currently, how many cigarettes per day do you smoke on average?
|
11.5 Cigarettes per day
STANDARD_DEVIATION 8.1 • n=27 Participants • Among smokers only (N=54)
|
10.8 Cigarettes per day
STANDARD_DEVIATION 6.9 • n=27 Participants • Among smokers only (N=54)
|
11.1 Cigarettes per day
STANDARD_DEVIATION 7.5 • n=54 Participants • Among smokers only (N=54)
|
|
Currently, how many cigarettes per day does the patient's spouse smoke on average?
|
11.5 Cigarettes
STANDARD_DEVIATION 8.1 • n=27 Participants • For smokers only (N=54)
|
10.8 Cigarettes
STANDARD_DEVIATION 6.9 • n=27 Participants • For smokers only (N=54)
|
11.1 Cigarettes
STANDARD_DEVIATION 7.5 • n=54 Participants • For smokers only (N=54)
|
|
In the past year, how often did the patient's spouse smoke?
Never
|
20 Participants
n=39 Participants • Missing frequency = 23
|
24 Participants
n=42 Participants • Missing frequency = 23
|
44 Participants
n=81 Participants • Missing frequency = 23
|
|
In the past year, how often did the patient's spouse smoke?
At least once a week
|
3 Participants
n=39 Participants • Missing frequency = 23
|
1 Participants
n=42 Participants • Missing frequency = 23
|
4 Participants
n=81 Participants • Missing frequency = 23
|
|
In the past year, how often did the patient's spouse smoke?
Every day or almost every day
|
16 Participants
n=39 Participants • Missing frequency = 23
|
17 Participants
n=42 Participants • Missing frequency = 23
|
33 Participants
n=81 Participants • Missing frequency = 23
|
|
DSM5 - Substance-related or addictive disorders (whole life)
No
|
11 Participants
n=51 Participants
|
19 Participants
n=53 Participants
|
30 Participants
n=104 Participants
|
|
DSM5 - Substance-related or addictive disorders (whole life)
Yes
|
40 Participants
n=51 Participants
|
34 Participants
n=53 Participants
|
74 Participants
n=104 Participants
|
|
DSM5 - Substance-related or addictive disorders (whole life)
Alcohol · No
|
36 Participants
n=40 Participants • Only in patients with substance-related or addictive disorders (N=74)
|
34 Participants
n=34 Participants • Only in patients with substance-related or addictive disorders (N=74)
|
70 Participants
n=74 Participants • Only in patients with substance-related or addictive disorders (N=74)
|
|
DSM5 - Substance-related or addictive disorders (whole life)
Alcohol · Yes
|
4 Participants
n=40 Participants • Only in patients with substance-related or addictive disorders (N=74)
|
0 Participants
n=34 Participants • Only in patients with substance-related or addictive disorders (N=74)
|
4 Participants
n=74 Participants • Only in patients with substance-related or addictive disorders (N=74)
|
|
DSM5 - Substance-related or addictive disorders (whole life)
Tobacco · No
|
5 Participants
n=40 Participants • Only in patients with substance-related or addictive disorders (N=74)
|
0 Participants
n=34 Participants • Only in patients with substance-related or addictive disorders (N=74)
|
5 Participants
n=74 Participants • Only in patients with substance-related or addictive disorders (N=74)
|
|
DSM5 - Substance-related or addictive disorders (whole life)
Tobacco · Yes
|
35 Participants
n=40 Participants • Only in patients with substance-related or addictive disorders (N=74)
|
34 Participants
n=34 Participants • Only in patients with substance-related or addictive disorders (N=74)
|
69 Participants
n=74 Participants • Only in patients with substance-related or addictive disorders (N=74)
|
|
DSM5 - Substance-related or addictive disorders (whole life)
Cannabis · No
|
39 Participants
n=40 Participants • Only in patients with substance-related or addictive disorders (N=74)
|
34 Participants
n=34 Participants • Only in patients with substance-related or addictive disorders (N=74)
|
73 Participants
n=74 Participants • Only in patients with substance-related or addictive disorders (N=74)
|
|
DSM5 - Substance-related or addictive disorders (whole life)
Cannabis · Yes
|
1 Participants
n=40 Participants • Only in patients with substance-related or addictive disorders (N=74)
|
0 Participants
n=34 Participants • Only in patients with substance-related or addictive disorders (N=74)
|
1 Participants
n=74 Participants • Only in patients with substance-related or addictive disorders (N=74)
|
|
DSM5 - Substance-related or addictive disorders (whole life)
Other · No
|
39 Participants
n=40 Participants • Only in patients with substance-related or addictive disorders (N=74)
|
34 Participants
n=34 Participants • Only in patients with substance-related or addictive disorders (N=74)
|
73 Participants
n=74 Participants • Only in patients with substance-related or addictive disorders (N=74)
|
|
DSM5 - Substance-related or addictive disorders (whole life)
Other · Yes
|
1 Participants
n=40 Participants • Only in patients with substance-related or addictive disorders (N=74)
|
0 Participants
n=34 Participants • Only in patients with substance-related or addictive disorders (N=74)
|
1 Participants
n=74 Participants • Only in patients with substance-related or addictive disorders (N=74)
|
|
DSM5 - Whole Life
Depressive disorders · No
|
35 Participants
n=51 Participants
|
28 Participants
n=53 Participants
|
63 Participants
n=104 Participants
|
|
DSM5 - Whole Life
Depressive disorders · Yes
|
16 Participants
n=51 Participants
|
25 Participants
n=53 Participants
|
41 Participants
n=104 Participants
|
|
DSM5 - Whole Life
Bipolar and related disorders · No
|
51 Participants
n=51 Participants
|
51 Participants
n=53 Participants
|
102 Participants
n=104 Participants
|
|
DSM5 - Whole Life
Bipolar and related disorders · Yes
|
0 Participants
n=51 Participants
|
2 Participants
n=53 Participants
|
2 Participants
n=104 Participants
|
|
DSM5 - Whole Life
Anxiety disorders · No
|
38 Participants
n=51 Participants
|
39 Participants
n=53 Participants
|
77 Participants
n=104 Participants
|
|
DSM5 - Whole Life
Anxiety disorders · Yes
|
13 Participants
n=51 Participants
|
14 Participants
n=53 Participants
|
27 Participants
n=104 Participants
|
|
DSM5 - Whole Life
OCD and related · No
|
50 Participants
n=51 Participants
|
51 Participants
n=53 Participants
|
101 Participants
n=104 Participants
|
|
DSM5 - Whole Life
OCD and related · Yes
|
1 Participants
n=51 Participants
|
2 Participants
n=53 Participants
|
3 Participants
n=104 Participants
|
|
DSM5 - Whole Life
Disorders related to trauma or stressors · No
|
40 Participants
n=51 Participants
|
40 Participants
n=53 Participants
|
80 Participants
n=104 Participants
|
|
DSM5 - Whole Life
Disorders related to trauma or stressors · Yes
|
11 Participants
n=51 Participants
|
13 Participants
n=53 Participants
|
24 Participants
n=104 Participants
|
|
DSM5 - Whole Life
Substance-related or Addictive · No
|
11 Participants
n=51 Participants
|
19 Participants
n=53 Participants
|
30 Participants
n=104 Participants
|
|
DSM5 - Whole Life
Substance-related or Addictive · Yes
|
40 Participants
n=51 Participants
|
34 Participants
n=53 Participants
|
74 Participants
n=104 Participants
|
|
DSM5 - Substance-related or addictive disorders (current life)
No
|
29 Participants
n=51 Participants
|
37 Participants
n=53 Participants
|
66 Participants
n=104 Participants
|
|
DSM5 - Substance-related or addictive disorders (current life)
Yes
|
22 Participants
n=51 Participants
|
16 Participants
n=53 Participants
|
38 Participants
n=104 Participants
|
|
DSM5 - Current Life - Substance-related or addictive disorders
Alcohol · No
|
19 Participants
n=22 Participants • Only for patient with substance-related or addictive disorders (N=38)
|
15 Participants
n=16 Participants • Only for patient with substance-related or addictive disorders (N=38)
|
34 Participants
n=38 Participants • Only for patient with substance-related or addictive disorders (N=38)
|
|
DSM5 - Current Life - Substance-related or addictive disorders
Alcohol · Yes
|
3 Participants
n=22 Participants • Only for patient with substance-related or addictive disorders (N=38)
|
1 Participants
n=16 Participants • Only for patient with substance-related or addictive disorders (N=38)
|
4 Participants
n=38 Participants • Only for patient with substance-related or addictive disorders (N=38)
|
|
DSM5 - Current Life - Substance-related or addictive disorders
Tobacco · No
|
4 Participants
n=22 Participants • Only for patient with substance-related or addictive disorders (N=38)
|
1 Participants
n=16 Participants • Only for patient with substance-related or addictive disorders (N=38)
|
5 Participants
n=38 Participants • Only for patient with substance-related or addictive disorders (N=38)
|
|
DSM5 - Current Life - Substance-related or addictive disorders
Tobacco · Yes
|
18 Participants
n=22 Participants • Only for patient with substance-related or addictive disorders (N=38)
|
15 Participants
n=16 Participants • Only for patient with substance-related or addictive disorders (N=38)
|
33 Participants
n=38 Participants • Only for patient with substance-related or addictive disorders (N=38)
|
|
DSM5 - Current Life - Substance-related or addictive disorders
Cannabis · No
|
21 Participants
n=22 Participants • Only for patient with substance-related or addictive disorders (N=38)
|
16 Participants
n=16 Participants • Only for patient with substance-related or addictive disorders (N=38)
|
37 Participants
n=38 Participants • Only for patient with substance-related or addictive disorders (N=38)
|
|
DSM5 - Current Life - Substance-related or addictive disorders
Cannabis · Yes
|
1 Participants
n=22 Participants • Only for patient with substance-related or addictive disorders (N=38)
|
0 Participants
n=16 Participants • Only for patient with substance-related or addictive disorders (N=38)
|
1 Participants
n=38 Participants • Only for patient with substance-related or addictive disorders (N=38)
|
|
DSM5 - Current Life - Substance-related or addictive disorders
Other · No
|
22 Participants
n=22 Participants • Only for patient with substance-related or addictive disorders (N=38)
|
16 Participants
n=16 Participants • Only for patient with substance-related or addictive disorders (N=38)
|
38 Participants
n=38 Participants • Only for patient with substance-related or addictive disorders (N=38)
|
|
DSM5 - Current Life - Substance-related or addictive disorders
Other · Yes
|
0 Participants
n=22 Participants • Only for patient with substance-related or addictive disorders (N=38)
|
0 Participants
n=16 Participants • Only for patient with substance-related or addictive disorders (N=38)
|
0 Participants
n=38 Participants • Only for patient with substance-related or addictive disorders (N=38)
|
|
DSM5 - Substance-related or addictive disorders (Current Life)
Depressive disorders · No
|
47 Participants
n=51 Participants
|
48 Participants
n=53 Participants
|
95 Participants
n=104 Participants
|
|
DSM5 - Substance-related or addictive disorders (Current Life)
Depressive disorders · Yes
|
4 Participants
n=51 Participants
|
5 Participants
n=53 Participants
|
9 Participants
n=104 Participants
|
|
DSM5 - Substance-related or addictive disorders (Current Life)
Depressive disorders · Missing
|
0 Participants
n=51 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=104 Participants
|
|
DSM5 - Substance-related or addictive disorders (Current Life)
Bipolar and related disorders · No
|
51 Participants
n=51 Participants
|
51 Participants
n=53 Participants
|
102 Participants
n=104 Participants
|
|
DSM5 - Substance-related or addictive disorders (Current Life)
Bipolar and related disorders · Yes
|
0 Participants
n=51 Participants
|
2 Participants
n=53 Participants
|
2 Participants
n=104 Participants
|
|
DSM5 - Substance-related or addictive disorders (Current Life)
Bipolar and related disorders · Missing
|
0 Participants
n=51 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=104 Participants
|
|
DSM5 - Substance-related or addictive disorders (Current Life)
Anxiety disorders · No
|
45 Participants
n=51 Participants
|
43 Participants
n=53 Participants
|
88 Participants
n=104 Participants
|
|
DSM5 - Substance-related or addictive disorders (Current Life)
Anxiety disorders · Yes
|
6 Participants
n=51 Participants
|
10 Participants
n=53 Participants
|
16 Participants
n=104 Participants
|
|
DSM5 - Substance-related or addictive disorders (Current Life)
Anxiety disorders · Missing
|
0 Participants
n=51 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=104 Participants
|
|
DSM5 - Substance-related or addictive disorders (Current Life)
OCD and related · No
|
50 Participants
n=51 Participants
|
52 Participants
n=53 Participants
|
102 Participants
n=104 Participants
|
|
DSM5 - Substance-related or addictive disorders (Current Life)
OCD and related · Yes
|
0 Participants
n=51 Participants
|
1 Participants
n=53 Participants
|
1 Participants
n=104 Participants
|
|
DSM5 - Substance-related or addictive disorders (Current Life)
OCD and related · Missing
|
1 Participants
n=51 Participants
|
0 Participants
n=53 Participants
|
1 Participants
n=104 Participants
|
|
DSM5 - Substance-related or addictive disorders (Current Life)
Disorders related to trauma or stressors · No
|
47 Participants
n=51 Participants
|
50 Participants
n=53 Participants
|
97 Participants
n=104 Participants
|
|
DSM5 - Substance-related or addictive disorders (Current Life)
Disorders related to trauma or stressors · Yes
|
3 Participants
n=51 Participants
|
3 Participants
n=53 Participants
|
6 Participants
n=104 Participants
|
|
DSM5 - Substance-related or addictive disorders (Current Life)
Disorders related to trauma or stressors · Missing
|
1 Participants
n=51 Participants
|
0 Participants
n=53 Participants
|
1 Participants
n=104 Participants
|
|
Electronic cigarettes
No
|
25 Participants
n=27 Participants • Among smokers only (N=54)
|
24 Participants
n=27 Participants • Among smokers only (N=54)
|
49 Participants
n=54 Participants • Among smokers only (N=54)
|
|
Electronic cigarettes
Yes
|
2 Participants
n=27 Participants • Among smokers only (N=54)
|
3 Participants
n=27 Participants • Among smokers only (N=54)
|
5 Participants
n=54 Participants • Among smokers only (N=54)
|
|
Type of consumption of electronic cigarettes
With nicotine
|
1 Participants
n=2 Participants • Among electronic cigarette smokers only (N=5)
|
3 Participants
n=3 Participants • Among electronic cigarette smokers only (N=5)
|
4 Participants
n=5 Participants • Among electronic cigarette smokers only (N=5)
|
|
Type of consumption of electronic cigarettes
Without nicotine
|
1 Participants
n=2 Participants • Among electronic cigarette smokers only (N=5)
|
0 Participants
n=3 Participants • Among electronic cigarette smokers only (N=5)
|
1 Participants
n=5 Participants • Among electronic cigarette smokers only (N=5)
|
|
Ongoing psychotropic treatment(s)
No
|
35 Participants
n=51 Participants
|
35 Participants
n=53 Participants
|
70 Participants
n=104 Participants
|
|
Ongoing psychotropic treatment(s)
Yes
|
16 Participants
n=51 Participants
|
18 Participants
n=53 Participants
|
34 Participants
n=104 Participants
|
|
Current monitoring with regard to behaviour/emotional state
Missing
|
0 Participants
n=51 Participants
|
1 Participants
n=53 Participants
|
1 Participants
n=104 Participants
|
|
Current monitoring with regard to behaviour/emotional state
No
|
38 Participants
n=51 Participants
|
36 Participants
n=53 Participants
|
74 Participants
n=104 Participants
|
|
Current monitoring with regard to behaviour/emotional state
Yes
|
13 Participants
n=51 Participants
|
16 Participants
n=53 Participants
|
29 Participants
n=104 Participants
|
|
Type of professional
Psychologist · No
|
3 Participants
n=13 Participants • In patients with current monitoring of behaviour/emotional state (N=29)
|
3 Participants
n=16 Participants • In patients with current monitoring of behaviour/emotional state (N=29)
|
6 Participants
n=29 Participants • In patients with current monitoring of behaviour/emotional state (N=29)
|
|
Type of professional
Psychologist · Yes
|
10 Participants
n=13 Participants • In patients with current monitoring of behaviour/emotional state (N=29)
|
13 Participants
n=16 Participants • In patients with current monitoring of behaviour/emotional state (N=29)
|
23 Participants
n=29 Participants • In patients with current monitoring of behaviour/emotional state (N=29)
|
|
Type of professional
Psychiatrist · No
|
11 Participants
n=13 Participants • In patients with current monitoring of behaviour/emotional state (N=29)
|
14 Participants
n=16 Participants • In patients with current monitoring of behaviour/emotional state (N=29)
|
25 Participants
n=29 Participants • In patients with current monitoring of behaviour/emotional state (N=29)
|
|
Type of professional
Psychiatrist · Yes
|
2 Participants
n=13 Participants • In patients with current monitoring of behaviour/emotional state (N=29)
|
2 Participants
n=16 Participants • In patients with current monitoring of behaviour/emotional state (N=29)
|
4 Participants
n=29 Participants • In patients with current monitoring of behaviour/emotional state (N=29)
|
|
Type of professional
Health professional specialising in tobaccoology and addiction · No
|
13 Participants
n=13 Participants • In patients with current monitoring of behaviour/emotional state (N=29)
|
15 Participants
n=16 Participants • In patients with current monitoring of behaviour/emotional state (N=29)
|
28 Participants
n=29 Participants • In patients with current monitoring of behaviour/emotional state (N=29)
|
|
Type of professional
Health professional specialising in tobaccoology and addiction · Yes
|
0 Participants
n=13 Participants • In patients with current monitoring of behaviour/emotional state (N=29)
|
1 Participants
n=16 Participants • In patients with current monitoring of behaviour/emotional state (N=29)
|
1 Participants
n=29 Participants • In patients with current monitoring of behaviour/emotional state (N=29)
|
|
Type of professional
Other professional · No
|
12 Participants
n=13 Participants • In patients with current monitoring of behaviour/emotional state (N=29)
|
16 Participants
n=16 Participants • In patients with current monitoring of behaviour/emotional state (N=29)
|
28 Participants
n=29 Participants • In patients with current monitoring of behaviour/emotional state (N=29)
|
|
Type of professional
Other professional · Yes
|
1 Participants
n=13 Participants • In patients with current monitoring of behaviour/emotional state (N=29)
|
0 Participants
n=16 Participants • In patients with current monitoring of behaviour/emotional state (N=29)
|
1 Participants
n=29 Participants • In patients with current monitoring of behaviour/emotional state (N=29)
|
|
AUDIT Score (patient)
|
3.4 scores on a scale
STANDARD_DEVIATION 4.2 • n=51 Participants
|
2.9 scores on a scale
STANDARD_DEVIATION 2.0 • n=53 Participants
|
3.2 scores on a scale
STANDARD_DEVIATION 3.3 • n=104 Participants
|
|
Score Audit categorical variable (Patient)
No consumption
|
11 Participants
n=51 Participants
|
3 Participants
n=53 Participants
|
14 Participants
n=104 Participants
|
|
Score Audit categorical variable (Patient)
Low-risk consumption
|
33 Participants
n=51 Participants
|
44 Participants
n=53 Participants
|
77 Participants
n=104 Participants
|
|
Score Audit categorical variable (Patient)
Harmful consumption
|
3 Participants
n=51 Participants
|
6 Participants
n=53 Participants
|
9 Participants
n=104 Participants
|
|
Score Audit categorical variable (Patient)
Probable dependency
|
4 Participants
n=51 Participants
|
0 Participants
n=53 Participants
|
4 Participants
n=104 Participants
|
|
Fagerström score
|
3.4 scores on a scale
STANDARD_DEVIATION 2.6 • n=27 Participants • In smokers only (N=54)
|
3.4 scores on a scale
STANDARD_DEVIATION 2.6 • n=27 Participants • In smokers only (N=54)
|
3.4 scores on a scale
STANDARD_DEVIATION 2.6 • n=54 Participants • In smokers only (N=54)
|
|
MADRS Score (Quantitative variable)
|
7.9 scores on a scale
STANDARD_DEVIATION 7.6 • n=51 Participants
|
7.9 scores on a scale
STANDARD_DEVIATION 6.3 • n=53 Participants
|
7.9 scores on a scale
STANDARD_DEVIATION 6.9 • n=104 Participants
|
|
MADRS Score (Categorical variable)
Normothymic
|
30 Participants
n=51 Participants
|
28 Participants
n=53 Participants
|
58 Participants
n=104 Participants
|
|
MADRS Score (Categorical variable)
Mild depression
|
15 Participants
n=51 Participants
|
21 Participants
n=53 Participants
|
36 Participants
n=104 Participants
|
|
MADRS Score (Categorical variable)
Depression Medium
|
6 Participants
n=51 Participants
|
4 Participants
n=53 Participants
|
10 Participants
n=104 Participants
|
|
Score of Hamilton
|
5.6 scores on a scale
STANDARD_DEVIATION 6.1 • n=51 Participants
|
5.6 scores on a scale
STANDARD_DEVIATION 7.0 • n=53 Participants
|
5.6 scores on a scale
STANDARD_DEVIATION 6.5 • n=104 Participants
|
|
HEIQ (health Education Impact Questionnaire) score
|
118.6 scores on a scale
STANDARD_DEVIATION 11.7 • n=51 Participants
|
118.6 scores on a scale
STANDARD_DEVIATION 12.6 • n=53 Participants
|
118.6 scores on a scale
STANDARD_DEVIATION 12.1 • n=104 Participants
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Physical functioning
|
80.8 Standardized scores on a scale
n=49 Participants • Patients with available quality of life score
|
83.5 Standardized scores on a scale
n=51 Participants • Patients with available quality of life score
|
82.2 Standardized scores on a scale
n=100 Participants • Patients with available quality of life score
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Role functioning
|
81.3 Standardized scores on a scale
n=49 Participants • Patients with available quality of life score
|
80.1 Standardized scores on a scale
n=51 Participants • Patients with available quality of life score
|
80.7 Standardized scores on a scale
n=100 Participants • Patients with available quality of life score
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Emotional functioning
|
74.9 Standardized scores on a scale
n=49 Participants • Patients with available quality of life score
|
76.5 Standardized scores on a scale
n=51 Participants • Patients with available quality of life score
|
75.7 Standardized scores on a scale
n=100 Participants • Patients with available quality of life score
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Cognitive functioning
|
79.9 Standardized scores on a scale
n=49 Participants • Patients with available quality of life score
|
77.8 Standardized scores on a scale
n=51 Participants • Patients with available quality of life score
|
78.8 Standardized scores on a scale
n=100 Participants • Patients with available quality of life score
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Social functioning
|
76.2 Standardized scores on a scale
n=49 Participants • Patients with available quality of life score
|
74.8 Standardized scores on a scale
n=51 Participants • Patients with available quality of life score
|
75.5 Standardized scores on a scale
n=100 Participants • Patients with available quality of life score
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Fatigue
|
45.4 Standardized scores on a scale
n=49 Participants • Patients with available quality of life score
|
42 Standardized scores on a scale
n=51 Participants • Patients with available quality of life score
|
43.7 Standardized scores on a scale
n=100 Participants • Patients with available quality of life score
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Nausea and vomiting
|
8.5 Standardized scores on a scale
n=49 Participants • Patients with available quality of life score
|
7.8 Standardized scores on a scale
n=51 Participants • Patients with available quality of life score
|
8.2 Standardized scores on a scale
n=100 Participants • Patients with available quality of life score
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Pain
|
26.9 Standardized scores on a scale
n=49 Participants • Patients with available quality of life score
|
23.9 Standardized scores on a scale
n=51 Participants • Patients with available quality of life score
|
25.3 Standardized scores on a scale
n=100 Participants • Patients with available quality of life score
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Dyspnoea
|
24.5 Standardized scores on a scale
n=49 Participants • Patients with available quality of life score
|
20.9 Standardized scores on a scale
n=51 Participants • Patients with available quality of life score
|
22.7 Standardized scores on a scale
n=100 Participants • Patients with available quality of life score
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Insomnia
|
33.3 Standardized scores on a scale
n=49 Participants • Patients with available quality of life score
|
34.0 Standardized scores on a scale
n=51 Participants • Patients with available quality of life score
|
33.7 Standardized scores on a scale
n=100 Participants • Patients with available quality of life score
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Appetite loss
|
15.3 Standardized scores on a scale
n=48 Participants • Patients with available quality of life score
|
17.0 Standardized scores on a scale
n=51 Participants • Patients with available quality of life score
|
16.2 Standardized scores on a scale
n=99 Participants • Patients with available quality of life score
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Constipation
|
14.3 Standardized scores on a scale
n=49 Participants • Patients with available quality of life score
|
15.7 Standardized scores on a scale
n=51 Participants • Patients with available quality of life score
|
15.0 Standardized scores on a scale
n=100 Participants • Patients with available quality of life score
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Diarrhoea
|
10.2 Standardized scores on a scale
n=49 Participants • Patients with available quality of life score
|
18.3 Standardized scores on a scale
n=51 Participants • Patients with available quality of life score
|
14.3 Standardized scores on a scale
n=100 Participants • Patients with available quality of life score
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Financial difficulties
|
20.8 Standardized scores on a scale
n=48 Participants • Patients with available quality of life score
|
25.5 Standardized scores on a scale
n=51 Participants • Patients with available quality of life score
|
23.2 Standardized scores on a scale
n=99 Participants • Patients with available quality of life score
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Global health status/QoL (revised)
|
61.6 Standardized scores on a scale
n=48 Participants • Patients with available quality of life score
|
65.4 Standardized scores on a scale
n=51 Participants • Patients with available quality of life score
|
63.6 Standardized scores on a scale
n=99 Participants • Patients with available quality of life score
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Only patients with available data at 3 months
Individual decrease of 20% in the AUDIT (Alcohol Use Disorders Identification Test) score observed at 3 months AUDIT test measures alcohol consumption and makes it possible to describe its profiles. Its score ranges from 0 (no consumption) to 28 (alcohol dependence).
Outcome measures
| Measure |
Arm 1
n=48 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=53 Participants
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
Number of Patients With Individual Decrease of Tobacco Consumption at 3 Months
Success
|
23 Participants
|
19 Participants
|
|
Number of Patients With Individual Decrease of Tobacco Consumption at 3 Months
Success not maintained
|
18 Participants
|
29 Participants
|
|
Number of Patients With Individual Decrease of Tobacco Consumption at 3 Months
Missing
|
7 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 3 months and 6 monthsPopulation: Only patients with available data at 3 months and 6 months
Individual decrease of 20% in the AUDIT score observed at 3 months compared to the value collected at baseline and maintained at 6 months. Success depends on tobacco consumption at 3 months and 6 months. AUDIT test measures alcohol consumption and makes it possible to describe its profiles. Its score ranges from 0 to 28. Its score ranges from 0 (no consumption) to 28 (alcohol dependence).
Outcome measures
| Measure |
Arm 1
n=48 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=53 Participants
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
Number of Patients With Individual Decrease of Tobacco Consumption at 3 Months and Maintained at 6 Months
Success
|
17 participants
|
14 participants
|
|
Number of Patients With Individual Decrease of Tobacco Consumption at 3 Months and Maintained at 6 Months
Success not maintained
|
1 participants
|
1 participants
|
|
Number of Patients With Individual Decrease of Tobacco Consumption at 3 Months and Maintained at 6 Months
Missing
|
5 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Patients with tobacco or alcohol consumption at baseline and available data at 3 months
Individual reduction of around 20% in the average daily consumption of alcohol and/or tobacco (calculated on the basis of consumption schedules) between inclusion and the first follow-up at 3 months (with no increase in the other consumption if the subject has both alcohol and tobacco consumption at inclusion).
Outcome measures
| Measure |
Arm 1
n=48 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=53 Participants
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
Number of Patients With Individual Decreased of Alcohol and/or Tobacco Consumption
Success
|
12 Participants
|
15 Participants
|
|
Number of Patients With Individual Decreased of Alcohol and/or Tobacco Consumption
Failure
|
22 Participants
|
26 Participants
|
|
Number of Patients With Individual Decreased of Alcohol and/or Tobacco Consumption
Missing
|
14 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 3 months and 6 monthsPopulation: Patients with tobacco or alcohol consumption at baseline and data available at 3 months and 6 months
Individual reduction of around 20% in the average daily consumption of alcohol and/or tobacco (calculated on the basis of consumption schedules) between inclusion and the first follow-up at 3 months and a continuation of this reduction at the second follow-up at 6 months (with no increase in the other consumption if the subject has both alcohol and tobacco consumption at inclusion). Success depends on alcohol and tobacco level consumption at 3 months and 6 months.
Outcome measures
| Measure |
Arm 1
n=12 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=15 Participants
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
Number of Patients With Decreased Alcohol and/or Tobacco Consumption
Success
|
6 Participants
|
6 Participants
|
|
Number of Patients With Decreased Alcohol and/or Tobacco Consumption
Failure
|
2 Participants
|
2 Participants
|
|
Number of Patients With Decreased Alcohol and/or Tobacco Consumption
Missing
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Only patients with available data at baseline
Outcome measures
| Measure |
Arm 1
n=51 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=53 Participants
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
Number of Patients Per Current Treatments at Baseline
Surgery · Missing
|
0 Participants
|
0 Participants
|
|
Number of Patients Per Current Treatments at Baseline
Surgery · No
|
50 Participants
|
52 Participants
|
|
Number of Patients Per Current Treatments at Baseline
Surgery · Yes
|
1 Participants
|
1 Participants
|
|
Number of Patients Per Current Treatments at Baseline
Chemotherapy · Missing
|
0 Participants
|
0 Participants
|
|
Number of Patients Per Current Treatments at Baseline
Chemotherapy · No
|
4 Participants
|
2 Participants
|
|
Number of Patients Per Current Treatments at Baseline
Chemotherapy · Yes
|
47 Participants
|
51 Participants
|
|
Number of Patients Per Current Treatments at Baseline
Radiotherapy · Missing
|
0 Participants
|
0 Participants
|
|
Number of Patients Per Current Treatments at Baseline
Radiotherapy · No
|
50 Participants
|
53 Participants
|
|
Number of Patients Per Current Treatments at Baseline
Radiotherapy · Yes
|
1 Participants
|
0 Participants
|
|
Number of Patients Per Current Treatments at Baseline
Hormonotherapy · Missing
|
0 Participants
|
0 Participants
|
|
Number of Patients Per Current Treatments at Baseline
Hormonotherapy · No
|
49 Participants
|
52 Participants
|
|
Number of Patients Per Current Treatments at Baseline
Hormonotherapy · Yes
|
2 Participants
|
1 Participants
|
|
Number of Patients Per Current Treatments at Baseline
No treatment · Missing
|
0 Participants
|
0 Participants
|
|
Number of Patients Per Current Treatments at Baseline
No treatment · No
|
51 Participants
|
52 Participants
|
|
Number of Patients Per Current Treatments at Baseline
No treatment · Yes
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Only patients with available data at 3 months
Outcome measures
| Measure |
Arm 1
n=51 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=53 Participants
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
Number of Patients Per Current Treatments at 3 Months
Surgery · Missing
|
5 Participants
|
4 Participants
|
|
Number of Patients Per Current Treatments at 3 Months
Surgery · No
|
40 Participants
|
47 Participants
|
|
Number of Patients Per Current Treatments at 3 Months
Surgery · Yes
|
6 Participants
|
2 Participants
|
|
Number of Patients Per Current Treatments at 3 Months
Chemotherapy · Missing
|
5 Participants
|
4 Participants
|
|
Number of Patients Per Current Treatments at 3 Months
Chemotherapy · No
|
32 Participants
|
40 Participants
|
|
Number of Patients Per Current Treatments at 3 Months
Chemotherapy · Yes
|
14 Participants
|
9 Participants
|
|
Number of Patients Per Current Treatments at 3 Months
Radiotherapy · Missing
|
5 Participants
|
4 Participants
|
|
Number of Patients Per Current Treatments at 3 Months
Radiotherapy · No
|
36 Participants
|
30 Participants
|
|
Number of Patients Per Current Treatments at 3 Months
Radiotherapy · Yes
|
10 Participants
|
19 Participants
|
|
Number of Patients Per Current Treatments at 3 Months
Hormonotherapy · Missing
|
5 Participants
|
4 Participants
|
|
Number of Patients Per Current Treatments at 3 Months
Hormonotherapy · No
|
33 Participants
|
39 Participants
|
|
Number of Patients Per Current Treatments at 3 Months
Hormonotherapy · Yes
|
13 Participants
|
10 Participants
|
|
Number of Patients Per Current Treatments at 3 Months
No treatment · Missing
|
5 Participants
|
4 Participants
|
|
Number of Patients Per Current Treatments at 3 Months
No treatment · No
|
36 Participants
|
36 Participants
|
|
Number of Patients Per Current Treatments at 3 Months
No treatment · Yes
|
10 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Arm 1
n=51 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=53 Participants
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
Number of Patients Per Current Treatments at 6 Months
Surgery · Yes
|
2 Participants
|
0 Participants
|
|
Number of Patients Per Current Treatments at 6 Months
Surgery · Missing
|
0 Participants
|
0 Participants
|
|
Number of Patients Per Current Treatments at 6 Months
Surgery · No
|
49 Participants
|
53 Participants
|
|
Number of Patients Per Current Treatments at 6 Months
Chemotherapy · Missing
|
0 Participants
|
0 Participants
|
|
Number of Patients Per Current Treatments at 6 Months
Chemotherapy · No
|
46 Participants
|
47 Participants
|
|
Number of Patients Per Current Treatments at 6 Months
Chemotherapy · Yes
|
5 Participants
|
6 Participants
|
|
Number of Patients Per Current Treatments at 6 Months
Radiotherapy · Missing
|
0 Participants
|
0 Participants
|
|
Number of Patients Per Current Treatments at 6 Months
Radiotherapy · No
|
44 Participants
|
45 Participants
|
|
Number of Patients Per Current Treatments at 6 Months
Radiotherapy · Yes
|
7 Participants
|
8 Participants
|
|
Number of Patients Per Current Treatments at 6 Months
Hormonotherapy · Missing
|
0 Participants
|
0 Participants
|
|
Number of Patients Per Current Treatments at 6 Months
Hormonotherapy · No
|
35 Participants
|
28 Participants
|
|
Number of Patients Per Current Treatments at 6 Months
Hormonotherapy · Yes
|
16 Participants
|
25 Participants
|
|
Number of Patients Per Current Treatments at 6 Months
No treatment · Missing
|
0 Participants
|
0 Participants
|
|
Number of Patients Per Current Treatments at 6 Months
No treatment · No
|
42 Participants
|
43 Participants
|
|
Number of Patients Per Current Treatments at 6 Months
No treatment · Yes
|
9 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 months and 6 monthsOngoing psychotropic treatment(s) at baseline, 3 months and 6 months.
Outcome measures
| Measure |
Arm 1
n=51 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=53 Participants
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
Number of Patients Who Continued Psychotropic Treatment(s) at Baseline, 3 Months and 6 Months
Baseline · No
|
35 Participants
|
35 Participants
|
|
Number of Patients Who Continued Psychotropic Treatment(s) at Baseline, 3 Months and 6 Months
Baseline · Yes
|
16 Participants
|
18 Participants
|
|
Number of Patients Who Continued Psychotropic Treatment(s) at Baseline, 3 Months and 6 Months
Baseline · Missing
|
0 Participants
|
0 Participants
|
|
Number of Patients Who Continued Psychotropic Treatment(s) at Baseline, 3 Months and 6 Months
3 months · No
|
34 Participants
|
35 Participants
|
|
Number of Patients Who Continued Psychotropic Treatment(s) at Baseline, 3 Months and 6 Months
3 months · Yes
|
12 Participants
|
14 Participants
|
|
Number of Patients Who Continued Psychotropic Treatment(s) at Baseline, 3 Months and 6 Months
3 months · Missing
|
5 Participants
|
4 Participants
|
|
Number of Patients Who Continued Psychotropic Treatment(s) at Baseline, 3 Months and 6 Months
6 months · No
|
29 Participants
|
30 Participants
|
|
Number of Patients Who Continued Psychotropic Treatment(s) at Baseline, 3 Months and 6 Months
6 months · Yes
|
8 Participants
|
14 Participants
|
|
Number of Patients Who Continued Psychotropic Treatment(s) at Baseline, 3 Months and 6 Months
6 months · Missing
|
14 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 months and 6 monthsCurrent monitoring with regard to behaviour/emotional state
Outcome measures
| Measure |
Arm 1
n=51 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=53 Participants
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
Number of Patients Who Has Current Monitoring With Regard to Behaviour/Emotional State
Baseline · Missing
|
0 Participants
|
1 Participants
|
|
Number of Patients Who Has Current Monitoring With Regard to Behaviour/Emotional State
Baseline · No
|
38 Participants
|
36 Participants
|
|
Number of Patients Who Has Current Monitoring With Regard to Behaviour/Emotional State
Baseline · Yes
|
13 Participants
|
16 Participants
|
|
Number of Patients Who Has Current Monitoring With Regard to Behaviour/Emotional State
3 months · Missing
|
5 Participants
|
4 Participants
|
|
Number of Patients Who Has Current Monitoring With Regard to Behaviour/Emotional State
3 months · No
|
31 Participants
|
41 Participants
|
|
Number of Patients Who Has Current Monitoring With Regard to Behaviour/Emotional State
3 months · Yes
|
15 Participants
|
8 Participants
|
|
Number of Patients Who Has Current Monitoring With Regard to Behaviour/Emotional State
6 months · Missing
|
14 Participants
|
10 Participants
|
|
Number of Patients Who Has Current Monitoring With Regard to Behaviour/Emotional State
6 months · No
|
29 Participants
|
37 Participants
|
|
Number of Patients Who Has Current Monitoring With Regard to Behaviour/Emotional State
6 months · Yes
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Patients with current monitoring with regard to behaviour/emotional state
Type of professional followed for behaviour/emotional state at baseline
Outcome measures
| Measure |
Arm 1
n=13 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=16 Participants
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
Number of Patients Who by Type of Professional Monitored for Behaviour/Emotional State at Baseline
Psychologist · No
|
3 Participants
|
3 Participants
|
|
Number of Patients Who by Type of Professional Monitored for Behaviour/Emotional State at Baseline
Psychologist · Yes
|
10 Participants
|
13 Participants
|
|
Number of Patients Who by Type of Professional Monitored for Behaviour/Emotional State at Baseline
Psychiatrist · No
|
11 Participants
|
14 Participants
|
|
Number of Patients Who by Type of Professional Monitored for Behaviour/Emotional State at Baseline
Psychiatrist · Yes
|
2 Participants
|
2 Participants
|
|
Number of Patients Who by Type of Professional Monitored for Behaviour/Emotional State at Baseline
Health professional specialising in tobaccoology and addiction · No
|
13 Participants
|
15 Participants
|
|
Number of Patients Who by Type of Professional Monitored for Behaviour/Emotional State at Baseline
Health professional specialising in tobaccoology and addiction · Yes
|
0 Participants
|
1 Participants
|
|
Number of Patients Who by Type of Professional Monitored for Behaviour/Emotional State at Baseline
Other professional · No
|
12 Participants
|
16 Participants
|
|
Number of Patients Who by Type of Professional Monitored for Behaviour/Emotional State at Baseline
Other professional · Yes
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Patients with current monitoring with regard to behaviour/emotional state
Type of professional followed for behaviour/emotional state at 3 months
Outcome measures
| Measure |
Arm 1
n=15 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=8 Participants
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
Number of Patients Who by Type of Professional Monitored for Behaviour/Emotional State at 3 Months
Psychologist · No
|
4 Participants
|
3 Participants
|
|
Number of Patients Who by Type of Professional Monitored for Behaviour/Emotional State at 3 Months
Psychologist · Yes
|
11 Participants
|
5 Participants
|
|
Number of Patients Who by Type of Professional Monitored for Behaviour/Emotional State at 3 Months
Psychiatrist · No
|
13 Participants
|
5 Participants
|
|
Number of Patients Who by Type of Professional Monitored for Behaviour/Emotional State at 3 Months
Psychiatrist · Yes
|
2 Participants
|
3 Participants
|
|
Number of Patients Who by Type of Professional Monitored for Behaviour/Emotional State at 3 Months
Health professional specialising in tobaccoology and addiction · No
|
15 Participants
|
8 Participants
|
|
Number of Patients Who by Type of Professional Monitored for Behaviour/Emotional State at 3 Months
Health professional specialising in tobaccoology and addiction · Yes
|
0 Participants
|
0 Participants
|
|
Number of Patients Who by Type of Professional Monitored for Behaviour/Emotional State at 3 Months
Other professional · No
|
13 Participants
|
8 Participants
|
|
Number of Patients Who by Type of Professional Monitored for Behaviour/Emotional State at 3 Months
Other professional · Yes
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Patients with current monitoring with regard to behaviour/emotional state
Type of professional followed for behaviour/emotional state at 6 months
Outcome measures
| Measure |
Arm 1
n=8 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=6 Participants
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
Number of Patients by Type of Professional Monitored for Behaviour/Emotional State at 6 Months
Psychiatrist · No
|
5 Participants
|
2 Participants
|
|
Number of Patients by Type of Professional Monitored for Behaviour/Emotional State at 6 Months
Other professional · Yes
|
0 Participants
|
0 Participants
|
|
Number of Patients by Type of Professional Monitored for Behaviour/Emotional State at 6 Months
Psychologist · No
|
1 Participants
|
3 Participants
|
|
Number of Patients by Type of Professional Monitored for Behaviour/Emotional State at 6 Months
Psychologist · Yes
|
7 Participants
|
3 Participants
|
|
Number of Patients by Type of Professional Monitored for Behaviour/Emotional State at 6 Months
Psychiatrist · Yes
|
3 Participants
|
4 Participants
|
|
Number of Patients by Type of Professional Monitored for Behaviour/Emotional State at 6 Months
Health professional specialising in tobaccoology and addiction · No
|
7 Participants
|
6 Participants
|
|
Number of Patients by Type of Professional Monitored for Behaviour/Emotional State at 6 Months
Health professional specialising in tobaccoology and addiction · Yes
|
1 Participants
|
0 Participants
|
|
Number of Patients by Type of Professional Monitored for Behaviour/Emotional State at 6 Months
Other professional · No
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsAlcohol Use Disorders Identification Test-Consumption (AUDIT-C) score ranges from 0 (No alcohol consumption) to 12 (alcohol dependence). Consumption profiles can be derived from this. Higher scores indicate a worse outcome: alcohol dependence.
Outcome measures
| Measure |
Arm 1
n=51 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=53 Participants
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
AUDIT Score at Baseline, 3 Months, and 6 Months
Baseline
|
3.4 score on a scale
Standard Deviation 4.2
|
2.9 score on a scale
Standard Deviation 2.0
|
|
AUDIT Score at Baseline, 3 Months, and 6 Months
3 months
|
3.6 score on a scale
Standard Deviation 5.4
|
2.6 score on a scale
Standard Deviation 1.8
|
|
AUDIT Score at Baseline, 3 Months, and 6 Months
6 months
|
3.0 score on a scale
Standard Deviation 4.9
|
2.7 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline, 3 months and 6 monthsPopulation: Only smokers who have completed form at baseline, 3 months and 6 months.
Outcome measures
| Measure |
Arm 1
n=27 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=27 Participants
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
Currently, How Many Cigarettes Per Day do You Smoke on Average?
Baseline
|
11.5 Cigarettes per day
Standard Deviation 8.1
|
10.8 Cigarettes per day
Standard Deviation 6.9
|
|
Currently, How Many Cigarettes Per Day do You Smoke on Average?
3 months
|
9.3 Cigarettes per day
Standard Deviation 6.1
|
10.4 Cigarettes per day
Standard Deviation 7.0
|
|
Currently, How Many Cigarettes Per Day do You Smoke on Average?
6 months
|
9.1 Cigarettes per day
Standard Deviation 6.9
|
11.0 Cigarettes per day
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: Baseline, 3 months and 6 monthsPopulation: Only smokers at baseline (N=54), 3 months (N=37) and 6 months (N=30).
Outcome measures
| Measure |
Arm 1
n=27 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=27 Participants
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
Number of Patients Who Consume Electronic Cigarettes
Baseline · No
|
25 Participants
|
24 Participants
|
|
Number of Patients Who Consume Electronic Cigarettes
Baseline · Yes
|
2 Participants
|
3 Participants
|
|
Number of Patients Who Consume Electronic Cigarettes
3 months · No
|
17 Participants
|
16 Participants
|
|
Number of Patients Who Consume Electronic Cigarettes
3 months · Yes
|
3 Participants
|
1 Participants
|
|
Number of Patients Who Consume Electronic Cigarettes
6 months · No
|
15 Participants
|
12 Participants
|
|
Number of Patients Who Consume Electronic Cigarettes
6 months · Yes
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 months and 6 monthsPopulation: Patient with electronic cigarette use and who answered the form
Outcome measures
| Measure |
Arm 1
n=3 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=3 Participants
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
Type of Consumption of Electronic Cigarettes
3 months · With nicotine
|
2 Participants
|
1 Participants
|
|
Type of Consumption of Electronic Cigarettes
Baseline · With nicotine
|
1 Participants
|
3 Participants
|
|
Type of Consumption of Electronic Cigarettes
Baseline · Without nicotine
|
1 Participants
|
0 Participants
|
|
Type of Consumption of Electronic Cigarettes
3 months · Without nicotine
|
1 Participants
|
0 Participants
|
|
Type of Consumption of Electronic Cigarettes
6 months · With nicotine
|
1 Participants
|
1 Participants
|
|
Type of Consumption of Electronic Cigarettes
6 months · Without nicotine
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: In smokers only (N=54 smokers at baseline)
Fagerström test assesses tobacco consumption and makes it possible to describe patterns of tobacco addiction. Its score ranges from 0 (non-addiction to smoking) to 10 (strong or very strong dependence on tobacco).
Outcome measures
| Measure |
Arm 1
n=27 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=27 Participants
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
Fagerström Score
Baseline
|
3.4 score on a scale
Standard Error 2.6
|
3.4 score on a scale
Standard Error 2.6
|
|
Fagerström Score
3 months
|
3.7 score on a scale
Standard Error 2.5
|
3.8 score on a scale
Standard Error 2.1
|
|
Fagerström Score
6 months
|
3.0 score on a scale
Standard Error 2.3
|
3.7 score on a scale
Standard Error 2.7
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Eligible and assessable patients who have completed the MADRS questionnaire at baseline, 3 months and 6 months. For this questionnaire, there were no missing data at each time point (baseline, 3 months and 6 months).
MADRS (Montgomery-Åsberg Depression Rating Scale) assesses the severity of depression in patients with mood disorders. Its score ranges from 0 (normothymic) to 60 (depression).
Outcome measures
| Measure |
Arm 1
n=51 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=53 Participants
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
MADRS Score
Baseline
|
7.9 score on a scale
Standard Error 7.6
|
7.9 score on a scale
Standard Error 6.3
|
|
MADRS Score
3 months
|
8.5 score on a scale
Standard Error 7.2
|
6.3 score on a scale
Standard Error 5.8
|
|
MADRS Score
6 months
|
7.9 score on a scale
Standard Error 7.9
|
4.8 score on a scale
Standard Error 5.2
|
SECONDARY outcome
Timeframe: Baseline, 3 months and 6 monthsPopulation: Eligible and assessable patients who have completed the Hamilton questionnaire at baseline, 3 months and 6 months. For this questionnaire, there were no missing data at each time point (baseline, 3 months and 6 months).
Hamilton test assesses symptoms of anxiety. Its score ranges from 0 to 56. The higher the score is, the more severe the depression is.
Outcome measures
| Measure |
Arm 1
n=51 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=53 Participants
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
Score of Hamilton
Baseline
|
5.6 score on a scale
Standard Deviation 6.1
|
5.6 score on a scale
Standard Deviation 7.0
|
|
Score of Hamilton
3 months
|
4.5 score on a scale
Standard Deviation 5.3
|
3.5 score on a scale
Standard Deviation 4.1
|
|
Score of Hamilton
6 months
|
4.4 score on a scale
Standard Deviation 6.0
|
2.6 score on a scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Participants who completed at least one item of the questionnaire. Note that some participants may not have completed the 30 items of the questionnaires, which explains why the number of participants differs for the different items of the questionnaires.
QLQ-C30 questionnaire (EORTC) assesses quality of life across 15 dimensions : * 5 functional dimensions : Physical functioning, Role functioning, Emotional, Cognitive functioning, Social functioning; * 9 symptomatic dimensions: Fatigue, Nausea and vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Diarrhoea, Financial difficulties; * 1 global health dimension: Global health status/QoL Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health.
Outcome measures
| Measure |
Arm 1
n=51 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=53 Participants
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Emotional functioning
|
67.9 scores on a scale
Standard Deviation 27.0
|
76.3 scores on a scale
Standard Deviation 20.2
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Cognitive functioning
|
75.8 scores on a scale
Standard Deviation 27.1
|
81.6 scores on a scale
Standard Deviation 18.5
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Social functioning
|
70.6 scores on a scale
Standard Deviation 29.9
|
78.7 scores on a scale
Standard Deviation 24.3
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Fatigue
|
42.0 scores on a scale
Standard Deviation 26.4
|
39.0 scores on a scale
Standard Deviation 21.1
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Nausea and vomiting
|
5.3 scores on a scale
Standard Deviation 12.6
|
3.9 scores on a scale
Standard Deviation 7.9
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Pain
|
26.4 scores on a scale
Standard Deviation 25.3
|
28.7 scores on a scale
Standard Deviation 21.3
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Dyspnoea
|
15.4 scores on a scale
Standard Deviation 25.9
|
27.0 scores on a scale
Standard Deviation 19.2
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Insomnia
|
42.3 scores on a scale
Standard Deviation 32.5
|
37.6 scores on a scale
Standard Deviation 30.8
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Appetite loss
|
14.6 scores on a scale
Standard Deviation 22.4
|
12.1 scores on a scale
Standard Deviation 18.9
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Constipation
|
8.9 scores on a scale
Standard Deviation 18.3
|
5.7 scores on a scale
Standard Deviation 12.7
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Diarrhoea
|
4.9 scores on a scale
Standard Deviation 11.9
|
8.0 scores on a scale
Standard Deviation 22.4
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Financial difficulties
|
23.8 scores on a scale
Standard Deviation 32.3
|
21.3 scores on a scale
Standard Deviation 28.2
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Global health status/QoL
|
61.1 scores on a scale
Standard Deviation 17.9
|
64.2 scores on a scale
Standard Deviation 18.4
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Physical functioning
|
81.0 scores on a scale
Standard Deviation 16.4
|
82.1 scores on a scale
Standard Deviation 18.1
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Role functioning
|
84.6 scores on a scale
Standard Deviation 18.0
|
89.0 scores on a scale
Standard Deviation 17.8
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants who completed at least one item of the questionnaire. Note that some participants may not have completed the 30 items of the questionnaires, which explains why the number of participants differs for the different items of the questionnaires.
QLQ-C30 questionnaire (EORTC) assesses quality of life across 15 dimensions : * 5 functional dimensions : Physical functioning, Role functioning, Emotional, Cognitive functioning, Social functioning; * 9 symptomatic dimensions: Fatigue, Nausea and vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Diarrhoea, Financial difficulties; * 1 global health dimension: Global health status/QoL Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health.
Outcome measures
| Measure |
Arm 1
n=51 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=53 Participants
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Physical functioning
|
80.2 scores on a scale
Standard Deviation 18.5
|
86.0 scores on a scale
Standard Deviation 16.0
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Role functioning
|
81.5 scores on a scale
Standard Deviation 24.1
|
88.2 scores on a scale
Standard Deviation 19.5
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Emotional functioning
|
62.6 scores on a scale
Standard Deviation 28.7
|
75.6 scores on a scale
Standard Deviation 18.2
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Cognitive functioning
|
72.5 scores on a scale
Standard Deviation 30.2
|
78.5 scores on a scale
Standard Deviation 21.8
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Social functioning
|
70.7 scores on a scale
Standard Deviation 33.4
|
81.7 scores on a scale
Standard Deviation 27.6
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Fatigue
|
44.1 scores on a scale
Standard Deviation 23.6
|
31.4 scores on a scale
Standard Deviation 20.5
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Nausea and vomiting
|
7.2 scores on a scale
Standard Deviation 20.6
|
4.1 scores on a scale
Standard Deviation 12.2
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Pain
|
27.0 scores on a scale
Standard Deviation 27.0
|
26.8 scores on a scale
Standard Deviation 25.8
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Dyspnoea
|
17.1 scores on a scale
Standard Deviation 24.4
|
21.1 scores on a scale
Standard Deviation 27.6
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Insomnia
|
48.6 scores on a scale
Standard Deviation 33.0
|
37.4 scores on a scale
Standard Deviation 32.7
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Appetite loss
|
13.5 scores on a scale
Standard Deviation 24.2
|
3.3 scores on a scale
Standard Deviation 10.0
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Constipation
|
20.7 scores on a scale
Standard Deviation 31.8
|
9.8 scores on a scale
Standard Deviation 22.7
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Diarrhoea
|
5.4 scores on a scale
Standard Deviation 18.4
|
7.5 scores on a scale
Standard Deviation 16.0
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Financial difficulties
|
23.1 scores on a scale
Standard Deviation 33.6
|
22.8 scores on a scale
Standard Deviation 35.3
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Global health status/QoL
|
58.3 scores on a scale
Standard Deviation 20.7
|
63.6 scores on a scale
Standard Deviation 20.6
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Patients with available score at baseline or 3 months or 6 months.
HEIQ (Health Education Impact Questionnaire) assesses the concept of empowerment (health-promoting behaviours, commitment, social integration, etc.). Its scores range from 0 to 160. Higher scores mean a better health-related empowerment .
Outcome measures
| Measure |
Arm 1
n=51 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=53 Participants
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
HEIQ Score
Baseline
|
119 scores on a scale
Standard Deviation 11.7
|
119 scores on a scale
Standard Deviation 12.6
|
|
HEIQ Score
3 months
|
114 scores on a scale
Standard Deviation 11.2
|
117.5 scores on a scale
Standard Deviation 12.5
|
|
HEIQ Score
6 months
|
118 scores on a scale
Standard Deviation 13.4
|
120 scores on a scale
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: Baseline, 3 months and 6 monthsPopulation: Patients with available score.
This score ranges from 0 to 140. The questionnaire consists of 14 questions on motivation to change alcohol/tobacco consumption habits, each with a response scale ranging from 0 (probably not) to 10 (probably). For each question, a sub-score ranges from 0 to 10 is given and then a total score of motivation to change consumption habits is calculated by adding up all the answers to the 14 items. The higher the score is, greater the patient's willingness to change his or her alcohol/tobacco consumption.
Outcome measures
| Measure |
Arm 1
n=51 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=53 Participants
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
Motivation Score to Change Consumption Habits (Alcohol/Tobacco)
Baseline
|
121 scores on a scale
Standard Deviation 22.9
|
117.5 scores on a scale
Standard Deviation 32.0
|
|
Motivation Score to Change Consumption Habits (Alcohol/Tobacco)
3 months
|
129 scores on a scale
Standard Deviation 29.0
|
126 scores on a scale
Standard Deviation 38.5
|
|
Motivation Score to Change Consumption Habits (Alcohol/Tobacco)
6 months
|
120 scores on a scale
Standard Deviation 19.6
|
126 scores on a scale
Standard Deviation 31.7
|
SECONDARY outcome
Timeframe: 3 monthsOutcome measures
| Measure |
Arm 1
n=51 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=53 Participants
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
Satisfaction Questionnaire
Would you have liked the questions on consumption to have been asked at another time? · Don't know
|
0 Participants
|
0 Participants
|
|
Satisfaction Questionnaire
Do you think it would be important to ask cancer patients about their consumption behaviour? · Missing
|
14 Participants
|
6 Participants
|
|
Satisfaction Questionnaire
Do you think it would be important to ask cancer patients about their consumption behaviour? · No
|
1 Participants
|
2 Participants
|
|
Satisfaction Questionnaire
Do you think it would be important to ask cancer patients about their consumption behaviour? · Yes
|
30 Participants
|
42 Participants
|
|
Satisfaction Questionnaire
Do you think it would be important to ask cancer patients about their consumption behaviour? · Don't know
|
6 Participants
|
3 Participants
|
|
Satisfaction Questionnaire
Would it be useful to ask cancer patients about their alcohol/tobacco consumption behaviour · Missing
|
14 Participants
|
7 Participants
|
|
Satisfaction Questionnaire
Would it be useful to ask cancer patients about their alcohol/tobacco consumption behaviour · No
|
1 Participants
|
1 Participants
|
|
Satisfaction Questionnaire
Would it be useful to ask cancer patients about their alcohol/tobacco consumption behaviour · Yes
|
33 Participants
|
40 Participants
|
|
Satisfaction Questionnaire
Would it be useful to ask cancer patients about their alcohol/tobacco consumption behaviour · Don't know
|
3 Participants
|
5 Participants
|
|
Satisfaction Questionnaire
Would you have liked the questions on consumption to have been asked at another time? · Missing
|
16 Participants
|
6 Participants
|
|
Satisfaction Questionnaire
Would you have liked the questions on consumption to have been asked at another time? · No
|
29 Participants
|
41 Participants
|
|
Satisfaction Questionnaire
Would you have liked the questions on consumption to have been asked at another time? · Yes
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 3 monthsSatisfaction score ranges from 1 to 10. Low scores indicate less satisfaction.
Outcome measures
| Measure |
Arm 1
n=51 Participants
Arm 1: Motivational Intervention group
Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
|
Arm 2
n=53 Participants
Arm 2: Educational advises group
Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
|
|---|---|---|
|
On a Scale of 1 to 10 How Would You Rate Your Overall Satisfaction With Having Benefited From a Brief Intervention at the Bergonié Institute?
10
|
12 Participants
|
11 Participants
|
|
On a Scale of 1 to 10 How Would You Rate Your Overall Satisfaction With Having Benefited From a Brief Intervention at the Bergonié Institute?
Missing
|
15 Participants
|
6 Participants
|
|
On a Scale of 1 to 10 How Would You Rate Your Overall Satisfaction With Having Benefited From a Brief Intervention at the Bergonié Institute?
3
|
0 Participants
|
1 Participants
|
|
On a Scale of 1 to 10 How Would You Rate Your Overall Satisfaction With Having Benefited From a Brief Intervention at the Bergonié Institute?
5
|
3 Participants
|
5 Participants
|
|
On a Scale of 1 to 10 How Would You Rate Your Overall Satisfaction With Having Benefited From a Brief Intervention at the Bergonié Institute?
6
|
2 Participants
|
4 Participants
|
|
On a Scale of 1 to 10 How Would You Rate Your Overall Satisfaction With Having Benefited From a Brief Intervention at the Bergonié Institute?
7
|
0 Participants
|
3 Participants
|
|
On a Scale of 1 to 10 How Would You Rate Your Overall Satisfaction With Having Benefited From a Brief Intervention at the Bergonié Institute?
8
|
11 Participants
|
17 Participants
|
|
On a Scale of 1 to 10 How Would You Rate Your Overall Satisfaction With Having Benefited From a Brief Intervention at the Bergonié Institute?
9
|
8 Participants
|
6 Participants
|
Adverse Events
Groupe 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Groupe 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Marion Barrault Couchouron, Coordinating Investigator
Institute Bergonie
Phone: 0556337805
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place