Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-24 @ 2:11 PM
NCT ID:
NCT05634395
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.
Detailed Description:
BACKGROUND: In metropolitan France in 2017, 58,968 new cases of breast cancer (BC) were estimated, of which 25,283 (46.7%) involved women older than 65 years. Older patients with cancer often present complex health needs, in particular because of the burden of comorbidities combined with the effects of aging, the cancer and its treatments. GrannyFit aims to use an activity tracker to identify and describe various digital profiles (physical activity, sleep) in women over 70 years of age treated de novo or recurrent (local or distant) BC.
METHODS: 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.
DISCUSSION: GrannyFit will make it possible, through the use of an activity tracker, to visualize changes, over a one-year period, in the lifestyle of older BC patients. This study identify more precisely the unmets needs of this population and optimize their care through specific paths. This trial will also pave the way for interventional studies on physical activity and sleep interventions in this population.
Study:
NCT05634395
Study Brief:
Protocol Section:
NCT05634395