Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer (TS-PAC)

Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer: The TS-PAC Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: Remote monitoring

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33600
    • Institut Bergonie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Remote monitoring for elderly patients with cancer	Other: Remote monitoring; Online remote monitoring tool during the care of patients over the age of 65 who are receiving medical treatment for cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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): 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.	3 months

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Institut Bergonié
• Investigators: Principal Investigator: Mathilde CABART, Dr, Institut Bergonie

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Actual): November 29, 2023
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Elderly patients; Remote monitoring; Ambulatory care
• Additional Relevant MeSH Terms: Neoplasms; Health Services Administration; Delivery of Health Care; Telemedicine; Patient Care Management; Remote Patient Monitoring
• Other Study ID Numbers: IB 2020-03; 2020-A02584-35 (Other Identifier: ANSM IDRCB number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No