Informations générales (source: ClinicalTrials.gov)
Digital Phenotyping (Physical Activity, Sleep) in Women Over 70 Years of Age Treated for Breast Cancer With Any Type of Treatment (GrannyFit)
Interventional
N/A
Institut Curie (Voir sur ClinicalTrials)
février 2023
mai 2026
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/12/2024 12:44:15 | Contacter | |||
| CLCC RENE HUGUENIN INSTITUT CURIE | 04/12/2024 12:44:02 | Contacter | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Léon Bérard - 69008 - Lyon - France | Catherine TERRET | Contact (sur clinicalTrials) | |||
| Institut GODINOT - 51100 - Reims - France | Christelle JOUANNAUD, MD | Contact (sur clinicalTrials) | |||
Critères
Femme
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.
- 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.
- 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,