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Recruiting
NCT05634395
Digital Phenotyping in Women Over 70 Years of Age Treated for Breast Cancer With Any Type of Treatment
Conditions: Breast Cancer
Sex: Female
Ages: 70 Years – N/A
Phase: NA
Enrollment: 200
Sponsor: Institut Curie
Location: France
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.
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,
Source: ClinicalTrials.gov (NCT05634395). StuddyBuddy aggregates publicly available trial information.