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

NCT ID: NCT05634395

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-17
• Study Completion Date: 2026-05-19

Brief 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.

Detailed Description

BACKGROUND: In metropolitan France in 2017, 58,968 new cases of breast cancer (BC) were estimated, of which 25,283 (46.7%) involved women older than 65 years. Older patients with cancer often present complex health needs, in particular because of the burden of comorbidities combined with the effects of aging, the cancer and its treatments. GrannyFit aims to use an activity tracker to identify and describe various digital profiles (physical activity, sleep) in women over 70 years of age treated de novo or recurrent (local or distant) BC.

METHODS: 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.

DISCUSSION: GrannyFit will make it possible, through the use of an activity tracker, to visualize changes, over a one-year period, in the lifestyle of older BC patients. This study identify more precisely the unmets needs of this population and optimize their care through specific paths. This trial will also pave the way for interventional studies on physical activity and sleep interventions in this population.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention with activity tracker

Women allocated to the intervention arm will used an activity tracker

Group Type: EXPERIMENTAL

Activity tracker

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Women over 70 years of age,
• With histologically confirmed invasive breast cancer,
• Regardless of histological subtype (hormone receptor positive (HR+), negative (HR-), with or without HER2 overexpression, or triple negative)
• Treated with local (surgery, radiotherapy) or systemic (hormone therapy, monotherapy, anti HER2, chemotherapy: patient is eligible for inclusion up to one month after initial diagnosis or recurrence (local or distant) of breast cancer,
• PS ≤ 2,
• Willing and available to invest in the project for the duration of the study,
• Using a personal smartphone or personal tablet compatible with the "Withings Health Mate" app (iOS 10/android 5.0 and later) and with an internet connection,
• Affiliated with a social security plan,
• Having dated and signed an informed consent,
• Able to read, write and understand French.

Exclusion Criteria

• Presence of disabling metastases,
• Moderate to severe cognitive impairment,
• Persons deprived of liberty or under guardianship,
• Inability to undergo the medical follow-up of the trial for geographical, social or psychological reasons,

• Minimum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Curie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabien Reyal, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Curie

Locations

Centre Léon Bérard

Lyon, , France

Institut Curie

Paris, , France

Institut GODINOT

Reims, , France

Institut Curie

Saint-Cloud, , France

Countries

France

Other Identifiers

IC 2021-08

Identifier Type: -

Identifier Source: org_study_id