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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A02584-35 | Other Identifier | ANSM IDRCB number |
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Monocentric, prospective cohort pilot study evaluating the feasibility of a online remote monitoring tool during the care of patients over 65 years of age being medically treated for 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).
In parallel, patient will continue standard follow-up with their referring oncologist and, if necessary (age ≥ 70 years and G8 score ≤ 14), will benefit from an onco-geriatric evaluation at inclusion then at 3 and 6 months.
At the end of 6 months of remote monitoring, the Coordinating Nurse will inform the patient of the end of study participation. Within one month of the end of the remote monitoring, the nurse will also remove the installation of the application and will organize the return of the equipment (tablet and/or 4G LTE key (4th Generation Long Term Evaluation)) if these were lent for the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote monitoring for elderly patients with cancer | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote monitoring | Other | Online remote monitoring tool during the care of patients over the age of 65 who are receiving medical treatment for cancer |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Who Completed at Least All of 9 Questionnaires at 3 Months | The primary endpoint is the proportion of patients who completed at least all of the following questionnaires at 3 months (9 questionnaires in total):
| 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Toxicities and Clinical Symptoms Reported by Patients Triggering a "Red" Alert. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Life expectancy less than 12 months. 2. Patient declining to use a tablet, computer, mobile phone or the Internet. 3. Patient not knowing how to read and understand French. 4. Technical impossibility of connecting to the Internet in the patient's living area.
5. Patient already included in this study or in another study evaluating a remote monitoring system.
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| Name | Affiliation | Role |
|---|---|---|
| Mathilde CABART, Dr | Institut Bergonié | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonie | Bordeaux | 33600 | France |
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First patient recruitment : June 15th 2021. Last patient recruitment : June 15th 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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:
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| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Between June 2021 and June 2023, 34 eligible patients were included in this study. 33 patients were eligible for analysis. For one patient, consent was lost, with no possibility of re-signing a new consent form as the patient died shortly after inclusion. The eCRF was never created and the Exolis application was never installed.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
|
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients Who Completed at Least All of 9 Questionnaires at 3 Months | The primary endpoint is the proportion of patients who completed at least all of the following questionnaires at 3 months (9 questionnaires in total):
| 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. | Posted | Count of Participants | Participants | 3 months |
Deaths were assessed during the 6-month study period, or until end of study for other reason (if patient's refusal to continue the study). This feasibility study did not collect adverse events according to CTCAE or MedDRA. Symptoms were self-reported weekly by participants (yes/no) for the assessment of symptoms triggering alerts only (reported in outcome measures).
This feasibility study did not formally collect adverse events according to CTCAE or MedDRA. Safety data were limited to subjective patient-reported outcomes (PROs), consisting of weekly yes/no self-reported symptoms (e.g., nausea, constipation), collected for the assessment of symptoms triggering alerts only (reported in outcome measures).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Mathilde Cabart | Institut Bergonie | +33 5 56 33 33 33 | m.cabart@bordeaux.unicancer.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2022 | Jan 21, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000098465 | Remote Patient Monitoring |
| ID | Term |
|---|---|
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Weekly during 6 months |
| Rate of Patients With Perceived Benefit of Treatment. | 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. | 3 months and 6 months |
| Rate of Patients With Satisfaction With the Use of the Remote Monitoring Tool | 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. | 3 months and 6 months |
| Quality of Life (EORTC QLQ-C30) | 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. | 3 months and 6 months |
| Depression and Anxiety Using the HAD Questionnaire | 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. | 3 months and 6 months |
| Number of Unscheduled Hospitalizations> 24 Hours and Emergency Room Visits | 6-month follow-up |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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:
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| Secondary | Number of Toxicities and Clinical Symptoms Reported by Patients Triggering a "Red" Alert. | 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. | Posted | Mean | Inter-Quartile Range | red alerts | Weekly during 6 months |
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| Secondary | Rate of Patients With Perceived Benefit of Treatment. | 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. | Out of the 32 eligible and assessable patients, 25 patients completed the perceived benefit questionnaire at 3 months, and 17 at 6 months | Posted | Count of Participants | Participants | 3 months and 6 months |
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| Secondary | Rate of Patients With Satisfaction With the Use of the Remote Monitoring Tool | 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. | Out of the 32 eligible and assessable patients, 24 patients completed the stastisfaction questionnaire at 3 months, and 20 at 6 months | Posted | Count of Participants | Participants | 3 months and 6 months |
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| Secondary | Quality of Life (EORTC QLQ-C30) | 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. | Out of the 32 eligible and assessable patients, 27 patients completed the QLQ-C30 questionnaire at 3 months, and 19 at 6 months. | Posted | Median | Full Range | standardized score | 3 months and 6 months |
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| Secondary | Depression and Anxiety Using the HAD Questionnaire | 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. | Out of the 32 eligible and assessable patients, 26 patients completed the HAD questionnaire at 3 months, and 20 at 6 months. | Posted | Median | Full Range | points | 3 months and 6 months |
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| Secondary | Number of Unscheduled Hospitalizations> 24 Hours and Emergency Room Visits | Posted | Number | hospitalisations and emergency visits | 6-month follow-up |
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| 1 |
| 33 |
| 0 |
| 0 |
| 0 |
| 0 |
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| Good |
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| Excellent |
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| 6 months |
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| Somewhat satisfied |
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| Very satisfied |
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| At 6 months |
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| Emotive functionning at 3 months |
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| Cognitive functionning at 3 months |
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| Social functionning at 3 months |
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| Global quality of life at 3 months |
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| Physical functionning at 6 months |
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| Role functionning at 6 months |
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| Emotive functionning at 6 months |
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| Cognitive functionning at 6 months |
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| Social functionning at 6 months |
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| Global quality of life at 6 months |
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| Anxiety score at 6 months |
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| Depression score at 6 months |
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