Clinical trial · Interventional
Digital Phenotyping in Women Over 70 Years of Age Treated for Breast Cancer With Any Type of Treatment
Digital Phenotyping (Physical Activity, Sleep) in Women Over 70 Years of Age Treated for Breast Cancer With Any Type of Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Activity tracker | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention with activity tracker
- description
- Women allocated to the intervention arm will used an activity tracker
- interventionNames
- Device: Activity tracker
Primary outcomes (3)
- measure
- Describe physical activity profiles in breast cancer patients over 70 years of age
- timeFrame
- Month 12
- description
- 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
- measure
- Describe sleep profiles in breast cancer patients over 70 years of age
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 70 Years
Show eligibility criteria text
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,
References
Publications (0)
Data not yet available