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

NCT05634395 | Active Not Recruiting DMC

• 1 other identifier: IC 2021-08
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

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.

Conditions

Breast Cancer

Keywords

digital; activity tracker; lifestyle; prevention

Outcome Measures

Primary Outcomes (3)

• Describe physical activity profiles in breast cancer patients over 70 years of age

  The activity tracker will register step counts for each day. the investigators will plot the average daily step counts and the 95% confidence interval across the entire study period. Then will will study the change in step count trajectory during the study. Linear mixed model will be used for describing change over time

  Month 12

• Describe sleep profiles in breast cancer patients over 70 years of age

  The activity tracker will register sleep duration for each day. The investigators will plot the average sleep duration and the 95% confidence interval across the entire study period. Then will tudy the change in sleep duration trajectory during the study. Linear mixed model will be used for describing change over time

  Month 12

• Identify digital profiles (physical activity, sleep) in breast cancer patients over 70 years of age

  To identify digital profiles, the investigators will combine step counts profiles and sleep profiles using mixed models with latent classes. The use of a mixed model will make it possible to analyze repeat data for the population, and to determine an average profile or trajectory for the whole population. The optimal number of classes will be determined a posteriori, based on a set of statistical and clinical criteria. The most widely used statistical criterion is the "Bayesian information criterion" (BIC), which penalizes the model's likelihood according to its complexity. The BIC, which is stricter than many other criteria, has been shown to have a better performance in simulations. The number of trajectories will also be based on clinical interpretation (whether it is worthwhile retaining classes containing very small numbers of subjects, etc.).

  Month 12

Secondary Outcomes (7)

• Analyze the effects of digital profiles on quality of life

  Month 6, Month 12

• Analyze the effects of digital profiles on fatigue

  Month 6, Month 12

• Analyze the effects of digital profiles on comorbidities

  Month 6, Month 12

• Analyze the effects of digital profiles on significant life events

  Month 6, Month 12

• Analyze the effects of digital profiles on physical activity

  Month 6, Month 12

Study Arms (1)

Intervention with activity tracker

EXPERIMENTAL

Women allocated to the intervention arm will used an activity tracker

Device: Activity tracker

Interventions

Activity tracker 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.

Intervention with activity tracker

Eligibility Criteria

• Age: 70 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (4)

Centre Léon Bérard

Lyon, 69008, France

Location

Institut Curie

Paris, 75005, France

Location

Institut GODINOT

Reims, 51100, France

Location

Institut Curie

Saint-Cloud, 92210, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• Fabien Reyal, MD

  Institut Curie

  PRINCIPAL INVESTIGATOR

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: November 22, 2022
• First Posted: December 2, 2022
• Study Start: February 17, 2023
• Primary Completion (Estimated): May 19, 2026
• Study Completion (Estimated): May 19, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR (4)