Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer: The TS-PAC Study
Overview
- Phase
- N/A
- Intervention
- Remote monitoring
- Conditions
- Cancer
- Sponsor
- Institut Bergonié
- Enrollment
- 33
- Locations
- 2
- Primary Endpoint
- Proportion of Patients Who Completed at Least All of 9 Questionnaires at 3 Months
- Status
- Active, Not Recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients 65 years of age and over.
- •Histologically proven cancer: breast, lung, ovary, prostate, bladder, kidney, ear-nose-throat, colon-rectum, melanoma, sarcoma, lymphoma, myeloma, or myelodysplastic syndrome.
- •Included before starting medical treatment (chemotherapy, hormone therapy, targeted therapy, immunotherapy or combination).
- •Informed consent dated and signed.
- •Patients affiliated with a French social security scheme in accordance with the French law on biomedical research (Article 1121-11 of the French Code of Public Health).
Exclusion Criteria
- •Life expectancy less than 12 months.
- •Patient declining to use a tablet, computer, mobile phone or the Internet.
- •Patient not knowing how to read and understand French.
- •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.
Arms & Interventions
Remote monitoring for elderly patients with cancer
Intervention: Remote monitoring
Outcomes
Primary Outcomes
Proportion of Patients Who Completed at Least All of 9 Questionnaires at 3 Months
Time Frame: 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): * 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.
Secondary Outcomes
- Number of Toxicities and Clinical Symptoms Reported by Patients Triggering a "Red" Alert.(Weekly during 6 months)
- Rate of Patients With Perceived Benefit of Treatment.(3 months and 6 months)
- Rate of Patients With Satisfaction With the Use of the Remote Monitoring Tool(3 months and 6 months)
- Quality of Life (EORTC QLQ-C30)(3 months and 6 months)
- Depression and Anxiety Using the HAD Questionnaire(3 months and 6 months)
- Number of Unscheduled Hospitalizations> 24 Hours and Emergency Room Visits(6-month follow-up)