Trial Outcomes & Findings for Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer (NCT NCT04913259)

Results Overview

The primary endpoint is the proportion of patients who completed at least all of the following questionnaires at 3 months (9 questionnaires in total): * 6 weekly questionnaires on toxicities and clinical symptoms completed within 3 months of the start of treatment: Toxicities and clinical symptoms will be assessed through 20 questions selected and adapted from the French version of the PRO (patient-reported outcomes) of the CTCAE (Common Terminology Criteria for Adverse Events); * 2 questionnaires assessing the health-related quality of life, completed before the start of treatment and at 3 months: Quality of life will be assessed using the EORTC QLQ-C30 questionnaire comprising 30 items. The targeted dimensions of the QLQ-C30 will be the five functional scales (physical, daily activity, emotional, cognitive and social) and the overall quality of life scale; * The questionnaire evaluating the perceived benefit of the treatment at 3 months.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

33 participants

Primary outcome timeframe

3 months

Results posted on

2026-03-03

Participant Flow

First patient recruitment : June 15th 2021. Last patient recruitment : June 15th 2023.

Participant milestones

Participant milestones
Measure	Remote Monitoring for Elderly Patients With Cancer Each patient will have to answer the remote monitoring questionnaires on a mobile phone, tablet or computer via the Internet. Responses will be sent to the referring oncologist and team (Coordinating Nurse). For each question, predetermined response thresholds have been established, triggering "orange" (to watch) or "red" alerts (intervention by the healthcare team required. Follow-up by self-questionnaire is as follows: * Weekly: toxicity and clinical symptom assessment questionnaire. * Every 3 months: QLQ-C30 +/- ELD14 quality of life questionnaires, HAD anxiety and depression assessment questionnaire, questionnaire for the subjective assessment of perceived benefit of treatment, and client satisfaction with use of the tool questionnaire.
Overall Study STARTED	33
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Remote Monitoring for Elderly Patients With Cancer Each patient will have to answer the remote monitoring questionnaires on a mobile phone, tablet or computer via the Internet. Responses will be sent to the referring oncologist and team (Coordinating Nurse). For each question, predetermined response thresholds have been established, triggering "orange" (to watch) or "red" alerts (intervention by the healthcare team required. Follow-up by self-questionnaire is as follows: * Weekly: toxicity and clinical symptom assessment questionnaire. * Every 3 months: QLQ-C30 +/- ELD14 quality of life questionnaires, HAD anxiety and depression assessment questionnaire, questionnaire for the subjective assessment of perceived benefit of treatment, and client satisfaction with use of the tool questionnaire.
Overall Study Protocol Violation	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Remote Monitoring for Elderly Patients With Cancer n=33 Participants Each patient will have to answer the remote monitoring questionnaires on a mobile phone, tablet or computer via the Internet. Responses will be sent to the referring oncologist and team (Coordinating Nurse). For each question, predetermined response thresholds have been established, triggering "orange" (to watch) or "red" alerts (intervention by the healthcare team required. Follow-up by self-questionnaire is as follows: * Weekly: toxicity and clinical symptom assessment questionnaire. * Every 3 months: QLQ-C30 +/- ELD14 quality of life questionnaires, HAD anxiety and depression assessment questionnaire, questionnaire for the subjective assessment of perceived benefit of treatment, and client satisfaction with use of the tool questionnaire.
Age, Continuous	76.7 years n=33 Participants
Sex: Female, Male Female	11 Participants n=33 Participants
Sex: Female, Male Male	22 Participants n=33 Participants
Region of Enrollment France	33 Participants n=33 Participants

PRIMARY outcome

Timeframe: 3 months

Population: 33 eligible patients were included in this study. One patient started treatment before completing the initiation visit with the nurse coordinator and was therefore excluded from the primary endpoint analysis, leaving 32 evaluable patients.

The primary endpoint is the proportion of patients who completed at least all of the following questionnaires at 3 months (9 questionnaires in total): * 6 weekly questionnaires on toxicities and clinical symptoms completed within 3 months of the start of treatment: Toxicities and clinical symptoms will be assessed through 20 questions selected and adapted from the French version of the PRO (patient-reported outcomes) of the CTCAE (Common Terminology Criteria for Adverse Events); * 2 questionnaires assessing the health-related quality of life, completed before the start of treatment and at 3 months: Quality of life will be assessed using the EORTC QLQ-C30 questionnaire comprising 30 items. The targeted dimensions of the QLQ-C30 will be the five functional scales (physical, daily activity, emotional, cognitive and social) and the overall quality of life scale; * The questionnaire evaluating the perceived benefit of the treatment at 3 months.

Outcome measures

Outcome measures
Measure	Remote Monitoring for Elderly Patients With Cancer n=32 Participants Each patient will have to answer the remote monitoring questionnaires on a mobile phone, tablet or computer via the Internet. Responses will be sent to the referring oncologist and team (Coordinating Nurse). For each question, predetermined response thresholds have been established, triggering "orange" (to watch) or "red" alerts (intervention by the healthcare team required. Follow-up by self-questionnaire is as follows: * Weekly: toxicity and clinical symptom assessment questionnaire. * Every 3 months: QLQ-C30 +/- ELD14 quality of life questionnaires, HAD anxiety and depression assessment questionnaire, questionnaire for the subjective assessment of perceived benefit of treatment, and client satisfaction with use of the tool questionnaire.
Proportion of Patients Who Completed at Least All of 9 Questionnaires at 3 Months	24 Participants

SECONDARY outcome

Timeframe: Weekly during 6 months

Toxicities and symptoms will be assessed weekly using 20 questions selected and adapted from the French version of the CTCAE PRO (Basch et al., 2014; National Cancer Institute, 2017). For each question, predetermined response thresholds have been established, triggering "orange" (to watch) or "red" alerts (intervention by the healthcare team required). The number of red alerts will be collected for each patient.

Outcome measures

Outcome measures
Measure	Remote Monitoring for Elderly Patients With Cancer n=32 Participants Each patient will have to answer the remote monitoring questionnaires on a mobile phone, tablet or computer via the Internet. Responses will be sent to the referring oncologist and team (Coordinating Nurse). For each question, predetermined response thresholds have been established, triggering "orange" (to watch) or "red" alerts (intervention by the healthcare team required. Follow-up by self-questionnaire is as follows: * Weekly: toxicity and clinical symptom assessment questionnaire. * Every 3 months: QLQ-C30 +/- ELD14 quality of life questionnaires, HAD anxiety and depression assessment questionnaire, questionnaire for the subjective assessment of perceived benefit of treatment, and client satisfaction with use of the tool questionnaire.
Number of Toxicities and Clinical Symptoms Reported by Patients Triggering a "Red" Alert.	9 red alerts Interval 4.5 to 12.0

SECONDARY outcome

Timeframe: 3 months and 6 months

Population: Out of the 32 eligible and assessable patients, 25 patients completed the perceived benefit questionnaire at 3 months, and 17 at 6 months

The subjective evaluation of the perceived benefit of treatment will be evaluated at 3 and 6 months by a questionnaire developed specifically for this project. The proportion of patients will be reported for each item of the questionnaire.

Outcome measures

Outcome measures
Measure	Remote Monitoring for Elderly Patients With Cancer n=25 Participants Each patient will have to answer the remote monitoring questionnaires on a mobile phone, tablet or computer via the Internet. Responses will be sent to the referring oncologist and team (Coordinating Nurse). For each question, predetermined response thresholds have been established, triggering "orange" (to watch) or "red" alerts (intervention by the healthcare team required. Follow-up by self-questionnaire is as follows: * Weekly: toxicity and clinical symptom assessment questionnaire. * Every 3 months: QLQ-C30 +/- ELD14 quality of life questionnaires, HAD anxiety and depression assessment questionnaire, questionnaire for the subjective assessment of perceived benefit of treatment, and client satisfaction with use of the tool questionnaire.
Rate of Patients With Perceived Benefit of Treatment. 3 months · Very poor	0 Participants
Rate of Patients With Perceived Benefit of Treatment. 3 months · Mediocre	4 Participants
Rate of Patients With Perceived Benefit of Treatment. 3 months · Good	16 Participants
Rate of Patients With Perceived Benefit of Treatment. 3 months · Excellent	5 Participants
Rate of Patients With Perceived Benefit of Treatment. 6 months · Very poor	1 Participants
Rate of Patients With Perceived Benefit of Treatment. 6 months · Mediocre	1 Participants
Rate of Patients With Perceived Benefit of Treatment. 6 months · Good	13 Participants
Rate of Patients With Perceived Benefit of Treatment. 6 months · Excellent	2 Participants

SECONDARY outcome

Timeframe: 3 months and 6 months

Population: Out of the 32 eligible and assessable patients, 24 patients completed the stastisfaction questionnaire at 3 months, and 20 at 6 months

Patient satisfaction with the use of the remote monitoring tool will be evaluated at 3 and 6 months by a questionnaire developed specifically for this project. The rate will be reported for each item.

Outcome measures

Outcome measures
Measure	Remote Monitoring for Elderly Patients With Cancer n=24 Participants Each patient will have to answer the remote monitoring questionnaires on a mobile phone, tablet or computer via the Internet. Responses will be sent to the referring oncologist and team (Coordinating Nurse). For each question, predetermined response thresholds have been established, triggering "orange" (to watch) or "red" alerts (intervention by the healthcare team required. Follow-up by self-questionnaire is as follows: * Weekly: toxicity and clinical symptom assessment questionnaire. * Every 3 months: QLQ-C30 +/- ELD14 quality of life questionnaires, HAD anxiety and depression assessment questionnaire, questionnaire for the subjective assessment of perceived benefit of treatment, and client satisfaction with use of the tool questionnaire.
Rate of Patients With Satisfaction With the Use of the Remote Monitoring Tool At 6 months · Somewhat satisfied	6 Participants
Rate of Patients With Satisfaction With the Use of the Remote Monitoring Tool At 3 months · Not at all satisfied	1 Participants
Rate of Patients With Satisfaction With the Use of the Remote Monitoring Tool At 3 months · Somewhat dissatisfied	1 Participants
Rate of Patients With Satisfaction With the Use of the Remote Monitoring Tool At 3 months · Somewhat satisfied	11 Participants
Rate of Patients With Satisfaction With the Use of the Remote Monitoring Tool At 3 months · Very satisfied	11 Participants
Rate of Patients With Satisfaction With the Use of the Remote Monitoring Tool At 6 months · Not at all satisfied	2 Participants
Rate of Patients With Satisfaction With the Use of the Remote Monitoring Tool At 6 months · Somewhat dissatisfied	0 Participants
Rate of Patients With Satisfaction With the Use of the Remote Monitoring Tool At 6 months · Very satisfied	12 Participants

SECONDARY outcome

Timeframe: 3 months and 6 months

Population: Out of the 32 eligible and assessable patients, 27 patients completed the QLQ-C30 questionnaire at 3 months, and 19 at 6 months.

Quality of life will be assessed at inclusion, 3 months and 6 months using the EORTC QLQ-C30 questionnaire (Aaronson et al., JNCI 1993). The targeted dimensions of the QLQ-C30 will be the 5 functional scales (physical, daily life, emotional, cognitive, and social) and the overall quality of life scale. Standardized scores are presented (range : 0-100). A higher score indicates a better functioning and quality of life.

Outcome measures

Outcome measures
Measure	Remote Monitoring for Elderly Patients With Cancer n=27 Participants Each patient will have to answer the remote monitoring questionnaires on a mobile phone, tablet or computer via the Internet. Responses will be sent to the referring oncologist and team (Coordinating Nurse). For each question, predetermined response thresholds have been established, triggering "orange" (to watch) or "red" alerts (intervention by the healthcare team required. Follow-up by self-questionnaire is as follows: * Weekly: toxicity and clinical symptom assessment questionnaire. * Every 3 months: QLQ-C30 +/- ELD14 quality of life questionnaires, HAD anxiety and depression assessment questionnaire, questionnaire for the subjective assessment of perceived benefit of treatment, and client satisfaction with use of the tool questionnaire.
Quality of Life (EORTC QLQ-C30) Cognitive functionning at 6 months	83.3 standardized score Interval 33.3 to 100.0
Quality of Life (EORTC QLQ-C30) Social functionning at 6 months	66.7 standardized score Interval 0.0 to 100.0
Quality of Life (EORTC QLQ-C30) Global quality of life at 6 months	75.0 standardized score Interval 16.7 to 100.0
Quality of Life (EORTC QLQ-C30) Physical functionning at 3 months	73.3 standardized score Interval 20.0 to 100.0
Quality of Life (EORTC QLQ-C30) Role functionning at 3 months	66.7 standardized score Interval 0.0 to 100.0
Quality of Life (EORTC QLQ-C30) Emotive functionning at 3 months	83.3 standardized score Interval 41.7 to 100.0
Quality of Life (EORTC QLQ-C30) Cognitive functionning at 3 months	66.7 standardized score Interval 16.7 to 100.0
Quality of Life (EORTC QLQ-C30) Social functionning at 3 months	66.7 standardized score Interval 0.0 to 100.0
Quality of Life (EORTC QLQ-C30) Global quality of life at 3 months	66.7 standardized score Interval 16.7 to 100.0
Quality of Life (EORTC QLQ-C30) Physical functionning at 6 months	73.3 standardized score Interval 26.7 to 100.0
Quality of Life (EORTC QLQ-C30) Role functionning at 6 months	83.3 standardized score Interval 16.7 to 100.0
Quality of Life (EORTC QLQ-C30) Emotive functionning at 6 months	75.0 standardized score Interval 50.0 to 100.0

SECONDARY outcome

Timeframe: 3 months and 6 months

Population: Out of the 32 eligible and assessable patients, 26 patients completed the HAD questionnaire at 3 months, and 20 at 6 months.

Depression and anxiety will be assessed at 3 months and 6 months, using the HAD questionnaire (Zigmond and Snaith, 1983). This questionnaire comprises 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to depression (total D), thus yielding two scores (maximum score for each = 21). A higher score indicates greater anxiety or depression.

Outcome measures

Outcome measures
Measure	Remote Monitoring for Elderly Patients With Cancer n=26 Participants Each patient will have to answer the remote monitoring questionnaires on a mobile phone, tablet or computer via the Internet. Responses will be sent to the referring oncologist and team (Coordinating Nurse). For each question, predetermined response thresholds have been established, triggering "orange" (to watch) or "red" alerts (intervention by the healthcare team required. Follow-up by self-questionnaire is as follows: * Weekly: toxicity and clinical symptom assessment questionnaire. * Every 3 months: QLQ-C30 +/- ELD14 quality of life questionnaires, HAD anxiety and depression assessment questionnaire, questionnaire for the subjective assessment of perceived benefit of treatment, and client satisfaction with use of the tool questionnaire.
Depression and Anxiety Using the HAD Questionnaire Anxiety score at 3 months	4.0 points Interval 0.0 to 12.0
Depression and Anxiety Using the HAD Questionnaire Depression score at 3 months	4.5 points Interval 0.0 to 13.0
Depression and Anxiety Using the HAD Questionnaire Anxiety score at 6 months	5.4 points Interval 0.0 to 10.0
Depression and Anxiety Using the HAD Questionnaire Depression score at 6 months	4.5 points Interval 0.0 to 12.0

SECONDARY outcome

Timeframe: 6-month follow-up

Outcome measures

Outcome measures
Measure	Remote Monitoring for Elderly Patients With Cancer n=32 Participants Each patient will have to answer the remote monitoring questionnaires on a mobile phone, tablet or computer via the Internet. Responses will be sent to the referring oncologist and team (Coordinating Nurse). For each question, predetermined response thresholds have been established, triggering "orange" (to watch) or "red" alerts (intervention by the healthcare team required. Follow-up by self-questionnaire is as follows: * Weekly: toxicity and clinical symptom assessment questionnaire. * Every 3 months: QLQ-C30 +/- ELD14 quality of life questionnaires, HAD anxiety and depression assessment questionnaire, questionnaire for the subjective assessment of perceived benefit of treatment, and client satisfaction with use of the tool questionnaire.
Number of Unscheduled Hospitalizations> 24 Hours and Emergency Room Visits	14 hospitalisations and emergency visits

Adverse Events

Remote Monitoring for Elderly Patients With Cancer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Mathilde Cabart

Institut Bergonie

Phone: +33 5 56 33 33 33

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place