Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer

NCT ID: NCT04913259

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-15

Study Completion Date

2026-06-01

Brief Summary

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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

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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.

Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Remote monitoring for elderly patients with cancer

Group Type OTHER

Remote monitoring

Intervention Type OTHER

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

Interventions

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Remote monitoring

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Bergonié

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mathilde CABART, Dr

Role: PRINCIPAL_INVESTIGATOR

Institut Bergonié

Locations

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Institut Bergonie

Bordeaux, , France

Site Status

Countries

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France

Other Identifiers

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2020-A02584-35

Identifier Type: OTHER

Identifier Source: secondary_id

IB 2020-03

Identifier Type: -

Identifier Source: org_study_id

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