Clinical trial NCT04913259: Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer
Official title: Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer: The TS-PAC Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Remote monitoring
Elderly patients
Cancer
Ambulatory care
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 33
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. Patients 65 years of age and over.
2. Histologically proven cancer: breast, lung, ovary, prostate, bladder, kidney, ear-nose-throat, colon-rectum, melanoma, sarcoma, lymphoma, myeloma, or myelodysplastic syndrome.
3. Included before starting medical treatment (chemotherapy, hormone therapy, targeted therapy, immunotherapy or combination).
4. Informed consent dated and signed.
5. 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. 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.

Primary outcomes:
measure: Proportion of patients who completed at least all of 9 questionnaires at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Number of toxicities and clinical symptoms reported by patients triggering a "red" alert.
timeFrame: Weekly during 6 months
measure: Rate of patients according to the compliant score.
timeFrame: Monthly during 6 months
measure: Rate of patients with perceived benefit of treatment.
timeFrame: 3 months and 6 months
measure: Rate of patients with satisfaction with the use of the remote monitoring tool
timeFrame: 3 months and 6 months
measure: Number of unscheduled hospitalizations> 24 hours and emergency room visits
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonie
Study officials:
affiliation: Institut Bergonié
name: Mathilde CABART, Dr
role: PRINCIPAL_INVESTIGATOR
References: