Trial Outcomes & Findings for CAP'Onco : Psychological and Social Consultation of Professional Accompaniment in Oncology (NCT NCT03302767)
NCT ID: NCT03302767
Last Updated: 2021-05-04
Results Overview
Standardised QLQ-C30 scoring according to EORTC scoring manual (Fayers et al. EORTC QLQ-C30 scoring manual. 2001). 15 dimensions are presented below. 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.
COMPLETED
NA
29 participants
At baseline and 5 months
2021-05-04
Participant Flow
Participant milestones
| Measure |
Psychological and Social Consultation
Psychological and Social Consultation at Baseline, during the study and at the end of follow-up
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Psychological and Social Consultation
n=29 Participants
Psychological and Social Consultation at Baseline, during the study and at the end of follow-up
|
|---|---|
|
Age, Continuous
|
44.9 years
n=29 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=29 Participants
|
|
Region of Enrollment
France
|
29 participants
n=29 Participants
|
|
Marital Status
Married
|
11 Participants
n=29 Participants
|
|
Marital Status
As a couple
|
7 Participants
n=29 Participants
|
|
Marital Status
Single
|
10 Participants
n=29 Participants
|
|
Marital Status
Widower
|
1 Participants
n=29 Participants
|
|
SOCIO-PROFESSIONAL CATEGORY
craftsman, shopkeeper, business owner
|
3 Participants
n=29 Participants
|
|
SOCIO-PROFESSIONAL CATEGORY
executive, intellectual profession
|
6 Participants
n=29 Participants
|
|
SOCIO-PROFESSIONAL CATEGORY
intermediate profession
|
5 Participants
n=29 Participants
|
|
SOCIO-PROFESSIONAL CATEGORY
employee
|
14 Participants
n=29 Participants
|
|
SOCIO-PROFESSIONAL CATEGORY
person without professional activity
|
1 Participants
n=29 Participants
|
|
PROFESSIONAL STATUS
Public Sector
|
13 Participants
n=29 Participants
|
|
PROFESSIONAL STATUS
Private Sector
|
12 Participants
n=29 Participants
|
|
PROFESSIONAL STATUS
Self-employed worker
|
3 Participants
n=29 Participants
|
|
PROFESSIONAL STATUS
Other
|
1 Participants
n=29 Participants
|
PRIMARY outcome
Timeframe: At baseline and 5 monthsPopulation: * At baseline, 1 patient did not complete the QLQ-C30 questionnaire. And of the remaining 28 patients, 1 patient has missing data for the score 'Dyspnoea'. * At 5 months, 1 patient did not complete the QLQ-C30 questionnaire. And of the remaining 28 patients : * 1 patient has missing data for the scores 'Constipation' and 'Diarrhoea' * 1 another patient has missing data for the score 'Fatigue'
Standardised QLQ-C30 scoring according to EORTC scoring manual (Fayers et al. EORTC QLQ-C30 scoring manual. 2001). 15 dimensions are presented below. 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 |
Psychological and Social Consultation
n=29 Participants
Psychological and Social Consultation at Baseline, during the study and at the end of follow-up
|
|---|---|
|
Quality of Life : EORTC QLQ-C30 Scores
Global health status/ quality of life - Baseline
|
61.0 scores on a scale
Interval 54.3 to 67.7
|
|
Quality of Life : EORTC QLQ-C30 Scores
Global health status/ quality of life - 5 months
|
70.8 scores on a scale
Interval 66.1 to 75.5
|
|
Quality of Life : EORTC QLQ-C30 Scores
Physical functioning - Baseline
|
82.9 scores on a scale
Interval 78.8 to 86.9
|
|
Quality of Life : EORTC QLQ-C30 Scores
Physical functioning - 5 months
|
83.2 scores on a scale
Interval 78.7 to 87.6
|
|
Quality of Life : EORTC QLQ-C30 Scores
Role functioning - Baseline
|
72.6 scores on a scale
Interval 63.6 to 81.6
|
|
Quality of Life : EORTC QLQ-C30 Scores
Role functioning - 5 months
|
78.6 scores on a scale
Interval 70.2 to 87.0
|
|
Quality of Life : EORTC QLQ-C30 Scores
Emotional functioning - Baseline
|
61.0 scores on a scale
Interval 51.3 to 70.7
|
|
Quality of Life : EORTC QLQ-C30 Scores
Emotional functioning - 5 months
|
67.0 scores on a scale
Interval 57.9 to 76.0
|
|
Quality of Life : EORTC QLQ-C30 Scores
Cognitive functioning - Baseline
|
61.3 scores on a scale
Interval 52.7 to 69.9
|
|
Quality of Life : EORTC QLQ-C30 Scores
Cognitive functioning - 5 months
|
73.2 scores on a scale
Interval 65.1 to 81.3
|
|
Quality of Life : EORTC QLQ-C30 Scores
Social functioning - Baseline
|
73.2 scores on a scale
Interval 62.9 to 83.5
|
|
Quality of Life : EORTC QLQ-C30 Scores
Social functioning - 5 months
|
82.1 scores on a scale
Interval 73.9 to 90.4
|
|
Quality of Life : EORTC QLQ-C30 Scores
Fatigue - Baseline
|
47.6 scores on a scale
Interval 40.0 to 55.2
|
|
Quality of Life : EORTC QLQ-C30 Scores
Fatigue - 5 months
|
43.6 scores on a scale
Interval 35.3 to 52.0
|
|
Quality of Life : EORTC QLQ-C30 Scores
Nausea/ vomiting - Baseline
|
3.6 scores on a scale
Interval 0.3 to 6.8
|
|
Quality of Life : EORTC QLQ-C30 Scores
Nausea/ vomiting - 5 months
|
3.0 scores on a scale
Interval -0.1 to 6.0
|
|
Quality of Life : EORTC QLQ-C30 Scores
Pain - Baseline
|
38.7 scores on a scale
Interval 29.5 to 47.8
|
|
Quality of Life : EORTC QLQ-C30 Scores
Pain - 5 months
|
33.3 scores on a scale
Interval 23.2 to 43.4
|
|
Quality of Life : EORTC QLQ-C30 Scores
Dyspnoea - Baseline
|
24.7 scores on a scale
Interval 14.0 to 35.4
|
|
Quality of Life : EORTC QLQ-C30 Scores
Dyspnoea - 5 months
|
16.7 scores on a scale
Interval 8.4 to 24.9
|
|
Quality of Life : EORTC QLQ-C30 Scores
Insomnia - Baseline
|
52.4 scores on a scale
Interval 38.1 to 66.6
|
|
Quality of Life : EORTC QLQ-C30 Scores
Insomnia - 5 months
|
41.7 scores on a scale
Interval 29.2 to 54.2
|
|
Quality of Life : EORTC QLQ-C30 Scores
Appetite loss - Baseline
|
9.5 scores on a scale
Interval 3.6 to 15.5
|
|
Quality of Life : EORTC QLQ-C30 Scores
Appetite loss - 5 months
|
6.0 scores on a scale
Interval 0.9 to 11.0
|
|
Quality of Life : EORTC QLQ-C30 Scores
Constipation - Baseline
|
21.4 scores on a scale
Interval 12.0 to 30.9
|
|
Quality of Life : EORTC QLQ-C30 Scores
Constipation - 5 months
|
16.0 scores on a scale
Interval 3.7 to 28.4
|
|
Quality of Life : EORTC QLQ-C30 Scores
Diarrhoea - Baseline
|
8.3 scores on a scale
Interval 1.6 to 15.0
|
|
Quality of Life : EORTC QLQ-C30 Scores
Diarrhoea - 5 months
|
3.7 scores on a scale
Interval -1.9 to 9.3
|
|
Quality of Life : EORTC QLQ-C30 Scores
Financial difficulties - Baseline
|
21.4 scores on a scale
Interval 11.3 to 31.5
|
|
Quality of Life : EORTC QLQ-C30 Scores
Financial difficulties - 5 months
|
15.5 scores on a scale
Interval 6.5 to 24.4
|
PRIMARY outcome
Timeframe: At baseline and 5 monthsPopulation: * At baseline, 2 patients did not complete the Cognitive complaints questionnaire * At 5 months, 1 patient did not complete the Cognitive complaints questionnaire
Cognitive complaints were evaluated by using the french Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) scale version 3 Assessed using median total score (range 0-132) and median scores of these 4 dimensions : * Perceived Cognitive Impairment (range 0-72) * Impact on quality of life (range 0-16) * Comments from others (range 0-16) * Perceived Cognitive Skills (range 0-28) Higher scores indicate better cognitive functioning.
Outcome measures
| Measure |
Psychological and Social Consultation
n=29 Participants
Psychological and Social Consultation at Baseline, during the study and at the end of follow-up
|
|---|---|
|
Cognitive Complaints : FACT Cog Scale Scores
Perceived Cognitive Impairment - Baseline
|
39 scores on a scale
Interval 8.0 to 69.0
|
|
Cognitive Complaints : FACT Cog Scale Scores
Perceived Cognitive Impairment - 5 months
|
50.5 scores on a scale
Interval 7.0 to 72.0
|
|
Cognitive Complaints : FACT Cog Scale Scores
Impact on quality of life - Baseline
|
8 scores on a scale
Interval 0.0 to 16.0
|
|
Cognitive Complaints : FACT Cog Scale Scores
Impact on quality of life - 5 months
|
14.0 scores on a scale
Interval 0.0 to 16.0
|
|
Cognitive Complaints : FACT Cog Scale Scores
Comments from others - Baseline
|
15 scores on a scale
Interval 5.0 to 16.0
|
|
Cognitive Complaints : FACT Cog Scale Scores
Comments from others - 5 months
|
16 scores on a scale
Interval 3.0 to 16.0
|
|
Cognitive Complaints : FACT Cog Scale Scores
Perceived Cognitive Skills - Baseline
|
13 scores on a scale
Interval 3.0 to 25.0
|
|
Cognitive Complaints : FACT Cog Scale Scores
Perceived Cognitive Skills - 5 months
|
17.5 scores on a scale
Interval 0.0 to 27.0
|
|
Cognitive Complaints : FACT Cog Scale Scores
Total score - Baseline
|
75 scores on a scale
Interval 16.0 to 125.0
|
|
Cognitive Complaints : FACT Cog Scale Scores
Total score - 5 months
|
96 scores on a scale
Interval 33.0 to 127.0
|
PRIMARY outcome
Timeframe: At baseline and 5 monthsPopulation: * At baseline, 1 patient did not complete the Professional recovery questionnaire * At 5 months : * 3 patients have missing data for the scores 'Work and administrative process', 'Work and physical/intellectual conditions' and 'Privacy and work' * 4 patients have missing data for the scores 'Positioning in relation to the job-post-mission', 'Emotion and work' and 'Labour relations' * 1 patient has missing data for the score 'Return to work'
Professional recovery was evaluated by using the Scale of motivation to Professional recovery. This scale was constructed for the needs of this exploratory research and has for vocation a later validation. It includes 62 questions and was assessed using median scores of these 7 dimensions : * Work and administrative process (0-100) * Positioning in relation to the job-post-mission (0-100) * Emotion and work (0-100) * Labour relations (0-100) * Work and physical/intellectual conditions (0-100) * Privacy and work (0-100) * Return to work (0-20) Higher scores represent better outcomes
Outcome measures
| Measure |
Psychological and Social Consultation
n=29 Participants
Psychological and Social Consultation at Baseline, during the study and at the end of follow-up
|
|---|---|
|
Professional Recovery Scale Scores
Work and administrative process - Baseline
|
58 scores on a scale
Interval 44.0 to 73.0
|
|
Professional Recovery Scale Scores
Work and administrative process - 5 months
|
61 scores on a scale
Interval 34.0 to 80.0
|
|
Professional Recovery Scale Scores
Positioning in relation to the job-post-mission - Baseline
|
40.5 scores on a scale
Interval 13.0 to 75.0
|
|
Professional Recovery Scale Scores
Positioning in relation to the job-post-mission - 5 months
|
50 scores on a scale
Interval 10.0 to 73.0
|
|
Professional Recovery Scale Scores
Emotion and work - Baseline
|
58.5 scores on a scale
Interval 28.0 to 88.0
|
|
Professional Recovery Scale Scores
Emotion and work - 5 months
|
60 scores on a scale
Interval 33.0 to 91.0
|
|
Professional Recovery Scale Scores
Labour relations - Baseline
|
55 scores on a scale
Interval 11.0 to 90.0
|
|
Professional Recovery Scale Scores
Labour relations - 5 months
|
59 scores on a scale
Interval 28.0 to 90.0
|
|
Professional Recovery Scale Scores
Work and physical/intellectual conditions - Baseline
|
42 scores on a scale
Interval 17.0 to 88.0
|
|
Professional Recovery Scale Scores
Work and physical/intellectual conditions - 5 months
|
52.5 scores on a scale
Interval 28.0 to 84.0
|
|
Professional Recovery Scale Scores
Privacy and work - Baseline
|
50.5 scores on a scale
Interval 29.0 to 72.0
|
|
Professional Recovery Scale Scores
Privacy and work - 5 months
|
60.5 scores on a scale
Interval 25.0 to 77.0
|
|
Professional Recovery Scale Scores
Return to work - Baseline
|
10 scores on a scale
Interval 1.0 to 20.0
|
|
Professional Recovery Scale Scores
Return to work - 5 months
|
14 scores on a scale
Interval 2.0 to 20.0
|
SECONDARY outcome
Timeframe: At baseline and 5 monthsPopulation: * At baseline: * 2 patients have missing data for the scores 'Emotional dimension', Behavioural dimension' and 'Sensory dimension' * 3 patients have missing data for the score 'Cognitive-mood dimension' * 3 patients finally have missing data for 'Total Score Fatigue Scale' * At 5 months, 1 patient did not complete the Tiredness questionnaire
Tiredness was evaluated by using the Piper Multidimensional Fatigue Inventory (MFI-20) revised scale Assessed using median total score (range 0-10) and median scores of these 4 tiredness dimensions : * Behavioural * Emotional * Sensory * Cognitive-mood Each dimension has range 0-10 with following interpretation: higher scores indicate greater severity of fatigue
Outcome measures
| Measure |
Psychological and Social Consultation
n=29 Participants
Psychological and Social Consultation at Baseline, during the study and at the end of follow-up
|
|---|---|
|
Tiredness : Piper MFI-20 Scale Scores
Emotional dimension - Baseline
|
5.4 scores on a scale
Interval 1.6 to 9.8
|
|
Tiredness : Piper MFI-20 Scale Scores
Behavioural dimension - 5 months
|
4.7 scores on a scale
Interval 0.5 to 9.2
|
|
Tiredness : Piper MFI-20 Scale Scores
Behavioural dimension - Baseline
|
5.3 scores on a scale
Interval 0.0 to 9.7
|
|
Tiredness : Piper MFI-20 Scale Scores
Emotional dimension - 5 months
|
5.7 scores on a scale
Interval 2.0 to 9.8
|
|
Tiredness : Piper MFI-20 Scale Scores
Sensory dimension - Baseline
|
4.2 scores on a scale
Interval 0.6 to 7.6
|
|
Tiredness : Piper MFI-20 Scale Scores
Sensory dimension - 5 months
|
4.0 scores on a scale
Interval 0.8 to 7.2
|
|
Tiredness : Piper MFI-20 Scale Scores
Cognitive-mood dimension - Baseline
|
4.8 scores on a scale
Interval 0.5 to 7.7
|
|
Tiredness : Piper MFI-20 Scale Scores
Cognitive-mood dimension - 5 months
|
3.9 scores on a scale
Interval 0.3 to 6.3
|
|
Tiredness : Piper MFI-20 Scale Scores
Total Score Fatigue Scale - Baseline
|
5.2 scores on a scale
Interval 0.9 to 7.8
|
|
Tiredness : Piper MFI-20 Scale Scores
Total Score Fatigue Scale - 5 months
|
4.7 scores on a scale
Interval 1.5 to 6.5
|
SECONDARY outcome
Timeframe: At baseline and 5 monthsPopulation: * At baseline, 2 patients did not complete the Anxio-depressive troubles questionnaire * At 5 months ,1 patient did not complete the Anxio-depressive troubles questionnaire
Anxio-depressive troubles were evaluated by using the Hospital Anxiety and Depression (HAD) scale. Assessed using median scores of these 2 dimensions : * Anxiety * Depression Each dimension has range 0-21 with following interpretation: higher scores represent worse outcomes (0-7 normal; 8-10 mild; 11-14 moderate; 15-21 severe)
Outcome measures
| Measure |
Psychological and Social Consultation
n=29 Participants
Psychological and Social Consultation at Baseline, during the study and at the end of follow-up
|
|---|---|
|
Anxio-depressive Troubles : HAD Scale Scores
Anxiety score - Baseline
|
10.0 scores on a scale
Interval 1.0 to 19.0
|
|
Anxio-depressive Troubles : HAD Scale Scores
Anxiety score - 5 months
|
8 scores on a scale
Interval 2.0 to 18.0
|
|
Anxio-depressive Troubles : HAD Scale Scores
Depression score - Baseline
|
7.0 scores on a scale
Interval 4.0 to 18.0
|
|
Anxio-depressive Troubles : HAD Scale Scores
Depression score - 5 months
|
6.5 scores on a scale
Interval 3.0 to 12.0
|
Adverse Events
Psychological and Social Consultation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place