Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer

Cancer Clinical Trial

— TS-PAC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04913259
• Other study ID #: IB 2020-03
• Secondary ID: 2020-A02584-35
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 25, 2021
• Est. completion date: May 25, 2023

Study information

• Verified date: May 2021
• Source: Institut Bergonié
• Contact: Mathilde CABART, MD
• Phone: (0)5.56.33.19.65
• Email: m.cabart[@]bordeaux.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 33
• Est. completion date: May 25, 2023
• Est. primary completion date: August 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Remote monitoring
Online remote monitoring tool during the care of patients over the age of 65 who are receiving medical treatment for cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut Bergonié

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who completed at least all of 9 questionnaires at 3 months		3 months
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.	Weekly during 6 months
Secondary	Rate of patients according to the compliant score.	Patient compliance with oral treatment will be assessed on a monthly basis during the treatment from the self-questionnaire MMAS-4 (Morisky et al., 1986) which has a range from 0 to 4. A high compliant score is defined by a score of 0, a medium compliance score (score=1 or 2) and a low compliance score (score=3 or 4).	Monthly during 6 months
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. It comprises 3 items.The proportion of patients will be reported for each item of the questionnaire.	3 months and 6 months
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. It comprises 2 items. The rate will be reported for each item.	3 months and 6 months
Secondary	Number of unscheduled hospitalizations> 24 hours and emergency room visits		3 months and 6 months