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Digital Phenotyping in Women Over 70 Years of Age Treated for Breast Cancer With Any Type of Treatment

NCT05634395 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-08-27

No results posted yet for this study

Summary

GrannyFit is a prospective, national, multicenter, single-arm open-label study. It will include a total of 200 participants over the age of 70 years treated for de novo or recurrent (local or distant) BC. Participants will receive a Withing Steel activity tracker, which they will be asked to wear 24 h per day for 12 months. The principal assessments will be performed at baseline, at 6 months and at 12 months. The investigators will evaluate clinical (e.g. comorbidities), lifestyle, quality of life, fatigue, and physical activity parameters. All questionnaires will be completed on a REDCap form, via a secure internet link.

Conditions

Interventions

DEVICE

Activity tracker

Participants will receive a Withings Steel activity tracker (Withings, Issy-les-Moulineaux, France), which they will be asked to wear 24 hours per day throughout the whole intervention (12 months). At baseline, the Withings Health Mate mobile phone application will be downloaded onto each participant's smartphone or tablet. The clinical research assistant will instruct the participant in the use of the activity tracker. The participant will then accept and activate the sharing of the data collected with the secure server dedicated to the "GrannyFit" study at the Institut Curie. Participants will be asked to synchronize the activity tracker regularly (ideally daily) via Bluetooth with the Withings Health Mate application, for automatic transfer of the data to the secure "GrannyFit" space.

Sponsors & Collaborators

  • Institut Curie

    lead OTHER

Principal Investigators

  • Fabien Reyal, MD · Institut Curie

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-17
Primary Completion
2026-05-19
Completion
2026-05-19

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05634395 on ClinicalTrials.gov