Using activity trackers to monitor lifestyle changes in older women with breast cancer
Digital Phenotyping (Physical Activity, Sleep) in Women Over 70 Years of Age Treated for Breast Cancer With Any Type of Treatment
This study tests whether using activity trackers can help older women who have been treated for breast cancer improve their health and lifestyle over a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 70 Years and up |
| Sex | Female |
| Sponsor | Institut Curie Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Lyon and 3 other locations) |
| Trial ID | NCT05634395 on ClinicalTrials.gov |
What this trial studies
GrannyFit is a national, multicenter study focusing on women over 70 years of age who have been treated for breast cancer. Participants will wear a Withings Steel activity tracker continuously for 12 months to monitor their physical activity, sleep patterns, and overall lifestyle changes. Assessments will be conducted at baseline, 6 months, and 12 months to evaluate clinical parameters, quality of life, fatigue, and physical activity. The study aims to identify unmet needs in this population and optimize their care through tailored interventions.
Who should consider this trial
Good fit: Ideal candidates are women over 70 years old with histologically confirmed invasive breast cancer, regardless of treatment type.
Not a fit: Patients with disabling metastases or severe cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life and care for older women with breast cancer by providing insights into their lifestyle and health needs.
How similar studies have performed: Other studies utilizing digital phenotyping and activity tracking in cancer patients have shown promise, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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,
Where this trial is running
Lyon and 3 other locations
- Centre Léon Bérard — Lyon, France (Recruiting)
- Institut Curie — Paris, France (Recruiting)
- Institut GODINOT — Reims, France (Recruiting)
- Institut Curie — Saint-Cloud, France (Recruiting)
Study contacts
- Principal investigator: Fabien Reyal, MD — Institut Curie
- Study coordinator: Fabien Reyal, MD
- Email: fabien.reyal@curie.fr
- Phone: +33144324660
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.