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ACTIVE NOT RECRUITING
NCT05634395
NA

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

Sponsor: Institut Curie

View on ClinicalTrials.gov

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.

Official title: Digital Phenotyping (Physical Activity, Sleep) in Women Over 70 Years of Age Treated for Breast Cancer With Any Type of Treatment

Key Details

Gender

FEMALE

Age Range

70 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2023-02-17

Completion Date

2026-05-19

Last Updated

2025-08-27

Healthy Volunteers

No

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.

Locations (4)

Centre Léon Bérard

Lyon, France

Institut Curie

Paris, France

Institut GODINOT

Reims, France

Institut Curie

Saint-Cloud, France