Trial Outcomes & Findings for Expectations and Priorities of Elderly Patients for a First Medical Treatment for Cancer (NCT NCT02821793)

NCT ID: NCT02821793

Last Updated: 2025-07-01

Results Overview

Prioritization among of the 4 items selected from a list of 8 expectations regarding the objectives of their treatment : treatment efficacy, life expectancy, autonomy, daily tasks, social activities, burden of treatment, toxicity and economic burden. For each expectation, the number and rate of priorization are reported.

Recruitment status

COMPLETED

Target enrollment

346 participants

Primary outcome timeframe

Day 0 initiation of treatment

Results posted on

2025-07-01

Participant Flow

Recruitment from January 2016 to January 2022 in 8 centers.

Elderly patients (≥ 70 years of age) were recruited by the investigating oncologists or geriatricians at organ-specific multidisciplinary consultation meetings (RCP) or during consultations. Younger patients were identified and recruited in the same way, mainly through RCP or specialized consultation by oncologists.

Participant milestones

Participant milestones
Measure
Elderly Patient (70 Years and Older)
Geriatric consultation, evaluation questionnaire: Geriatric consultation, evaluation questionnaire
Young Patient (18 Years - 69 Years)
Consultation, evaluation questionnaire: Consultation, evaluation questionnaire
Overall Study
STARTED
246
100
Overall Study
Major Deviation From Protocol
13
0
Overall Study
Major Deviation on Eligibility Criteria
6
1
Overall Study
COMPLETED
227
99
Overall Study
NOT COMPLETED
19
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Elderly Patient (70 Years and Older)
n=227 Participants
Geriatric consultation, evaluation questionnaire: Geriatric consultation, evaluation questionnaire
Young Patient (18 Years - 69 Years)
n=99 Participants
Consultation, evaluation questionnaire: Consultation, evaluation questionnaire
Total
n=326 Participants
Total of all reporting groups
Age, Continuous
79.2 years
n=227 Participants
61.3 years
n=99 Participants
75.9 years
n=326 Participants
Sex: Female, Male
Female
149 Participants
n=227 Participants
71 Participants
n=99 Participants
220 Participants
n=326 Participants
Sex: Female, Male
Male
78 Participants
n=227 Participants
28 Participants
n=99 Participants
106 Participants
n=326 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
France
227 participants
n=227 Participants
99 participants
n=99 Participants
326 participants
n=326 Participants

PRIMARY outcome

Timeframe: Day 0 initiation of treatment

Population: Patients without major deviation on study protocol and eligibility criteria who indicated at least one priority in the prioritization grid at the initiation of treatment

Prioritization among of the 4 items selected from a list of 8 expectations regarding the objectives of their treatment : treatment efficacy, life expectancy, autonomy, daily tasks, social activities, burden of treatment, toxicity and economic burden. For each expectation, the number and rate of priorization are reported.

Outcome measures

Outcome measures
Measure
Elderly Patient (70 Years and Older)
n=211 Participants
Geriatric consultation, evaluation questionnaire: Geriatric consultation, evaluation questionnaire
Young Patient (18 Years - 69 Years)
n=97 Participants
Consultation, evaluation questionnaire: Consultation, evaluation questionnaire
Priorities of Patients Receiving First Medical Treatment for Cancer at Treatment Initiation
Treatment efficacy
199 Participants
93 Participants
Priorities of Patients Receiving First Medical Treatment for Cancer at Treatment Initiation
Life expectancy
141 Participants
80 Participants
Priorities of Patients Receiving First Medical Treatment for Cancer at Treatment Initiation
Autonomy
181 Participants
67 Participants
Priorities of Patients Receiving First Medical Treatment for Cancer at Treatment Initiation
Daily tasks
115 Participants
44 Participants
Priorities of Patients Receiving First Medical Treatment for Cancer at Treatment Initiation
Social activities
80 Participants
47 Participants
Priorities of Patients Receiving First Medical Treatment for Cancer at Treatment Initiation
Burden of treatment
47 Participants
17 Participants
Priorities of Patients Receiving First Medical Treatment for Cancer at Treatment Initiation
Toxicity
66 Participants
35 Participants
Priorities of Patients Receiving First Medical Treatment for Cancer at Treatment Initiation
Economic burden
13 Participants
5 Participants

PRIMARY outcome

Timeframe: 3 months after initiation of treatment

Population: Patients without major deviation on study protocol and eligibility criteria who indicated at least one priority in the prioritization grid 3 months after initiation of treatment

Prioritization among of the 4 items selected from a list of 8 expectations regarding the objectives of their treatment : treatment efficacy, life expectancy, autonomy, daily tasks, social activities, burden of treatment, toxicity and economic burden. For each expectation, the number and rate of priorization are reported.

Outcome measures

Outcome measures
Measure
Elderly Patient (70 Years and Older)
n=155 Participants
Geriatric consultation, evaluation questionnaire: Geriatric consultation, evaluation questionnaire
Young Patient (18 Years - 69 Years)
n=88 Participants
Consultation, evaluation questionnaire: Consultation, evaluation questionnaire
Priorities of Patients Receiving First Medical Treatment for Cancer 3 Months After Initiation of Treatment
Economic burden
15 Participants
7 Participants
Priorities of Patients Receiving First Medical Treatment for Cancer 3 Months After Initiation of Treatment
Treatment efficacy
145 Participants
85 Participants
Priorities of Patients Receiving First Medical Treatment for Cancer 3 Months After Initiation of Treatment
Life expectancy
105 Participants
72 Participants
Priorities of Patients Receiving First Medical Treatment for Cancer 3 Months After Initiation of Treatment
Autonomy
134 Participants
66 Participants
Priorities of Patients Receiving First Medical Treatment for Cancer 3 Months After Initiation of Treatment
Daily tasks
93 Participants
44 Participants
Priorities of Patients Receiving First Medical Treatment for Cancer 3 Months After Initiation of Treatment
Social activities
69 Participants
46 Participants
Priorities of Patients Receiving First Medical Treatment for Cancer 3 Months After Initiation of Treatment
Burden of treatment
27 Participants
8 Participants
Priorities of Patients Receiving First Medical Treatment for Cancer 3 Months After Initiation of Treatment
Toxicity
30 Participants
22 Participants

SECONDARY outcome

Timeframe: Day 0 initiation of treatment

Population: Patients without major deviation on study protocol and eligibility criteria who indicated at least one priority in the prioritization grid at the initiation of treatment

Patients had to rate on a 5-point Likert scale (not at all / a little / moderately / quite / a lot) their expectations for treatment efficacy, life expectancy, autonomy, daily tasks, social activities, burden of treatment, toxicity and economic burden

Outcome measures

Outcome measures
Measure
Elderly Patient (70 Years and Older)
n=211 Participants
Geriatric consultation, evaluation questionnaire: Geriatric consultation, evaluation questionnaire
Young Patient (18 Years - 69 Years)
n=97 Participants
Consultation, evaluation questionnaire: Consultation, evaluation questionnaire
Expectations of Patients at Initiation of Treatment
Treatment efficacy · Not at all
3 Participants
0 Participants
Expectations of Patients at Initiation of Treatment
Treatment efficacy · A little
4 Participants
0 Participants
Expectations of Patients at Initiation of Treatment
Treatment efficacy · Moderately
5 Participants
0 Participants
Expectations of Patients at Initiation of Treatment
Treatment efficacy · Quite
24 Participants
4 Participants
Expectations of Patients at Initiation of Treatment
Treatment efficacy · A lot
173 Participants
91 Participants
Expectations of Patients at Initiation of Treatment
Treatment efficacy · Missing
2 Participants
2 Participants
Expectations of Patients at Initiation of Treatment
Life expectancy · Not at all
4 Participants
1 Participants
Expectations of Patients at Initiation of Treatment
Life expectancy · A little
5 Participants
1 Participants
Expectations of Patients at Initiation of Treatment
Life expectancy · Moderately
23 Participants
2 Participants
Expectations of Patients at Initiation of Treatment
Life expectancy · Quite
38 Participants
8 Participants
Expectations of Patients at Initiation of Treatment
Life expectancy · A lot
139 Participants
85 Participants
Expectations of Patients at Initiation of Treatment
Life expectancy · Missing
2 Participants
0 Participants
Expectations of Patients at Initiation of Treatment
Autonomy · Not at all
2 Participants
2 Participants
Expectations of Patients at Initiation of Treatment
Autonomy · A little
0 Participants
1 Participants
Expectations of Patients at Initiation of Treatment
Autonomy · Moderately
7 Participants
3 Participants
Expectations of Patients at Initiation of Treatment
Autonomy · Quite
23 Participants
16 Participants
Expectations of Patients at Initiation of Treatment
Autonomy · A lot
178 Participants
75 Participants
Expectations of Patients at Initiation of Treatment
Autonomy · Missing
1 Participants
0 Participants
Expectations of Patients at Initiation of Treatment
Daily tasks · Not at all
4 Participants
0 Participants
Expectations of Patients at Initiation of Treatment
Daily tasks · A little
9 Participants
1 Participants
Expectations of Patients at Initiation of Treatment
Daily tasks · Moderately
23 Participants
3 Participants
Expectations of Patients at Initiation of Treatment
Daily tasks · Quite
37 Participants
19 Participants
Expectations of Patients at Initiation of Treatment
Daily tasks · A lot
136 Participants
74 Participants
Expectations of Patients at Initiation of Treatment
Daily tasks · Missing
2 Participants
0 Participants
Expectations of Patients at Initiation of Treatment
Social activities · Not at all
5 Participants
0 Participants
Expectations of Patients at Initiation of Treatment
Social activities · A little
12 Participants
0 Participants
Expectations of Patients at Initiation of Treatment
Social activities · Moderately
21 Participants
4 Participants
Expectations of Patients at Initiation of Treatment
Social activities · Quite
36 Participants
19 Participants
Expectations of Patients at Initiation of Treatment
Social activities · A lot
135 Participants
74 Participants
Expectations of Patients at Initiation of Treatment
Social activities · Missing
2 Participants
0 Participants
Expectations of Patients at Initiation of Treatment
Burden of treatment · Not at all
6 Participants
6 Participants
Expectations of Patients at Initiation of Treatment
Burden of treatment · A little
6 Participants
4 Participants
Expectations of Patients at Initiation of Treatment
Burden of treatment · Moderately
25 Participants
8 Participants
Expectations of Patients at Initiation of Treatment
Burden of treatment · Quite
49 Participants
24 Participants
Expectations of Patients at Initiation of Treatment
Burden of treatment · A lot
124 Participants
55 Participants
Expectations of Patients at Initiation of Treatment
Burden of treatment · Missing
1 Participants
0 Participants
Expectations of Patients at Initiation of Treatment
Toxicity · Not at all
4 Participants
1 Participants
Expectations of Patients at Initiation of Treatment
Toxicity · A little
4 Participants
0 Participants
Expectations of Patients at Initiation of Treatment
Toxicity · Moderately
17 Participants
8 Participants
Expectations of Patients at Initiation of Treatment
Toxicity · Quite
40 Participants
16 Participants
Expectations of Patients at Initiation of Treatment
Toxicity · A lot
144 Participants
71 Participants
Expectations of Patients at Initiation of Treatment
Toxicity · Missing
2 Participants
1 Participants
Expectations of Patients at Initiation of Treatment
Economic burden · Not at all
28 Participants
17 Participants
Expectations of Patients at Initiation of Treatment
Economic burden · A little
15 Participants
6 Participants
Expectations of Patients at Initiation of Treatment
Economic burden · Moderately
34 Participants
13 Participants
Expectations of Patients at Initiation of Treatment
Economic burden · Quite
35 Participants
16 Participants
Expectations of Patients at Initiation of Treatment
Economic burden · A lot
92 Participants
45 Participants
Expectations of Patients at Initiation of Treatment
Economic burden · Missing
7 Participants
0 Participants

SECONDARY outcome

Timeframe: 3 months after initiation of treatment

Population: Patients without major deviation on study protocol and eligibility criteria who indicated at least one priority in the prioritization grid 3 months after initiation of treatment

Patients had to rate on a 5-point Likert scale (not at all / a little / moderately / quite / a lot) their expectations for treatment efficacy, life expectancy, autonomy, daily tasks, social activities, burden of treatment, toxicity and economic burden

Outcome measures

Outcome measures
Measure
Elderly Patient (70 Years and Older)
n=155 Participants
Geriatric consultation, evaluation questionnaire: Geriatric consultation, evaluation questionnaire
Young Patient (18 Years - 69 Years)
n=88 Participants
Consultation, evaluation questionnaire: Consultation, evaluation questionnaire
Expectations of Patients 3 Months After Initiation of Treatment
Autonomy · Missing
2 Participants
0 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Daily tasks · Not at all
2 Participants
2 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Daily tasks · A little
11 Participants
1 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Daily tasks · Moderately
17 Participants
4 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Daily tasks · Quite
38 Participants
23 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Daily tasks · A lot
87 Participants
58 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Daily tasks · Missing
0 Participants
0 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Social activities · Not at all
9 Participants
1 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Social activities · A little
14 Participants
2 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Social activities · Moderately
20 Participants
2 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Social activities · Quite
34 Participants
22 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Social activities · A lot
76 Participants
61 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Social activities · Missing
2 Participants
0 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Burden of treatment · Not at all
16 Participants
7 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Burden of treatment · A little
13 Participants
4 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Burden of treatment · Moderately
23 Participants
13 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Burden of treatment · Quite
41 Participants
26 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Burden of treatment · A lot
62 Participants
38 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Burden of treatment · Missing
0 Participants
0 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Toxicity · Not at all
14 Participants
2 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Toxicity · A little
4 Participants
2 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Toxicity · Moderately
14 Participants
8 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Toxicity · Quite
43 Participants
25 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Toxicity · A lot
80 Participants
51 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Toxicity · Missing
0 Participants
0 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Economic burden · Not at all
31 Participants
22 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Economic burden · A little
15 Participants
1 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Economic burden · Moderately
10 Participants
11 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Economic burden · Quite
30 Participants
23 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Economic burden · A lot
67 Participants
31 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Economic burden · Missing
2 Participants
0 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Treatment efficacy · Not at all
1 Participants
0 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Treatment efficacy · A little
5 Participants
4 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Treatment efficacy · Moderately
9 Participants
5 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Treatment efficacy · Quite
23 Participants
10 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Treatment efficacy · A lot
115 Participants
68 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Treatment efficacy · Missing
2 Participants
1 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Life expectancy · Not at all
4 Participants
1 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Life expectancy · A little
9 Participants
0 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Life expectancy · Moderately
18 Participants
2 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Life expectancy · Quite
31 Participants
14 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Life expectancy · A lot
91 Participants
70 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Life expectancy · Missing
2 Participants
1 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Autonomy · Not at all
2 Participants
1 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Autonomy · A little
2 Participants
0 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Autonomy · Moderately
5 Participants
3 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Autonomy · Quite
18 Participants
19 Participants
Expectations of Patients 3 Months After Initiation of Treatment
Autonomy · A lot
126 Participants
65 Participants

SECONDARY outcome

Timeframe: 3 months after initiation of treatment

Population: Patients without major deviation on study protocol and eligibility criteria who indicated at least one priority in the prioritization grid at the initiation of treatment and 3 months after treatment initiation

For each expectation, stability is defined as the prioritization of the expectation at treatment initiation and 3 months after treatment initiation

Outcome measures

Outcome measures
Measure
Elderly Patient (70 Years and Older)
n=155 Participants
Geriatric consultation, evaluation questionnaire: Geriatric consultation, evaluation questionnaire
Young Patient (18 Years - 69 Years)
n=88 Participants
Consultation, evaluation questionnaire: Consultation, evaluation questionnaire
Stability of Patients in Their Priorities at 3 Months
Treatment efficacy
137 Participants
82 Participants
Stability of Patients in Their Priorities at 3 Months
Life expectancy
74 Participants
62 Participants
Stability of Patients in Their Priorities at 3 Months
Autonomy
119 Participants
51 Participants
Stability of Patients in Their Priorities at 3 Months
Daily tasks
59 Participants
24 Participants
Stability of Patients in Their Priorities at 3 Months
Social activities
35 Participants
25 Participants
Stability of Patients in Their Priorities at 3 Months
Burden of treatment
8 Participants
1 Participants
Stability of Patients in Their Priorities at 3 Months
Toxicity
11 Participants
15 Participants
Stability of Patients in Their Priorities at 3 Months
Economic burden
2 Participants
1 Participants

SECONDARY outcome

Timeframe: From inclusion to the end of study

Population: Patients without major deviation on study protocol and eligibility criteria who indicated at least one priority in the prioritization grid at the initiation of treatment

Overall survival is defined as the time between the date of inclusion and the date of death, whatever the cause. The rate of overall survival is reported at 1 year

Outcome measures

Outcome measures
Measure
Elderly Patient (70 Years and Older)
n=211 Participants
Geriatric consultation, evaluation questionnaire: Geriatric consultation, evaluation questionnaire
Young Patient (18 Years - 69 Years)
n=97 Participants
Consultation, evaluation questionnaire: Consultation, evaluation questionnaire
1-year Overall Survival
77.5 percentage of patient
Interval 71.4 to 83.0
85.2 percentage of patient
Interval 76.2 to 90.9

SECONDARY outcome

Timeframe: Day 0 initiation of treatment

Population: Patients without major deviations from study protocol and eligibility criteria who indicated at least one priority in the prioritization grid at treatment initiation and whose physician also indicated at least one priority in the prioritization grid.

For each expectation, the agreement rate is defined by the same prioritization or non-prioritization by the patient-physician pairs.

Outcome measures

Outcome measures
Measure
Elderly Patient (70 Years and Older)
n=200 Participants
Geriatric consultation, evaluation questionnaire: Geriatric consultation, evaluation questionnaire
Young Patient (18 Years - 69 Years)
n=97 Participants
Consultation, evaluation questionnaire: Consultation, evaluation questionnaire
Agreement Rate for Prioritization of Expectations Between Patients and Physicians
Treatment efficacy
174 Participants
84 Participants
Agreement Rate for Prioritization of Expectations Between Patients and Physicians
Life expectancy
123 Participants
76 Participants
Agreement Rate for Prioritization of Expectations Between Patients and Physicians
Autonomy
128 Participants
47 Participants
Agreement Rate for Prioritization of Expectations Between Patients and Physicians
Daily tasks
100 Participants
45 Participants
Agreement Rate for Prioritization of Expectations Between Patients and Physicians
Social activities
122 Participants
52 Participants
Agreement Rate for Prioritization of Expectations Between Patients and Physicians
Burden of treatment
110 Participants
47 Participants
Agreement Rate for Prioritization of Expectations Between Patients and Physicians
Toxicity
91 Participants
46 Participants
Agreement Rate for Prioritization of Expectations Between Patients and Physicians
Economic burden
186 Participants
93 Participants

Adverse Events

Elderly Patient (70 Years and Older)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 47 deaths

Young Patient (18 Years - 69 Years)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 17 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pr Simone Mathoulin-Pelissier

Institut Bergonié

Phone: 0556333333

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place