NCT04913259

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for not_applicable cancer

Timeline
0mo left

Started Jun 2021

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

June 15, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2023

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

March 3, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

March 3, 2026

Status Verified

March 1, 2026

Enrollment Period

2.5 years

First QC Date

May 20, 2021

Results QC Date

January 21, 2026

Last Update Submit

March 2, 2026

Conditions

Cancer

Keywords

Remote monitoringElderly patientsCancerAmbulatory care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

Remote monitoring for elderly patients with cancer

OTHER
Other: Remote monitoring

Interventions

Remote monitoringOTHER

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

Remote monitoring for elderly patients with cancer

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.
  • \. Patient already included in this study or in another study evaluating a remote monitoring system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Bergonie

Bordeaux, 33600, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Remote Patient Monitoring

Intervention Hierarchy (Ancestors)

TelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Results Point of Contact

Title
Dr Mathilde Cabart
Organization
Institut Bergonie
m.cabart@bordeaux.unicancer.fr
+33 5 56 33 33 33

Study Officials

  • Mathilde CABART, Dr

    Institut Bergonié

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2021

First Posted

June 4, 2021

Study Start

June 15, 2021

Primary Completion

November 29, 2023

Study Completion (Estimated)

June 1, 2026

Last Updated

March 3, 2026

Results First Posted

March 3, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)