Clinical trial NCT05634395: Digital Phenotyping in Women Over 70 Years of Age Treated for Breast Cancer With Any Type of Treatment
Official title: Digital Phenotyping (Physical Activity, Sleep) in Women Over 70 Years of Age Treated for Breast Cancer With Any Type of Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: digital
activity tracker
lifestyle
prevention
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 200
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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,

Primary outcomes:
measure: Describe physical activity profiles in breast cancer patients over 70 years of age
timeFrame: Month 12
measure: Describe sleep profiles in breast cancer patients over 70 years of age
timeFrame: Month 12
measure: Identify digital profiles (physical activity, sleep) in breast cancer patients over 70 years of age
timeFrame: Month 12
Secondary outcomes:
measure: Analyze the effects of digital profiles on quality of life
timeFrame: Month 6, Month 12
measure: Analyze the effects of digital profiles on fatigue
timeFrame: Month 6, Month 12
measure: Analyze the effects of digital profiles on comorbidities
timeFrame: Month 6, Month 12
measure: Analyze the effects of digital profiles on significant life events
timeFrame: Month 6, Month 12
measure: Analyze the effects of digital profiles on physical activity
timeFrame: Month 6, Month 12
measure: Develop models for predicting fatigue changes during the course of treatment
timeFrame: Month 6, Month 12
measure: Develop models for predicting quality of life changes during the course of treatment
timeFrame: Month 6, Month 12
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
city: Paris
country: France
facility: Institut Curie
city: Reims
country: France
facility: Institut GODINOT
city: Saint-Cloud
country: France
facility: Institut Curie
Study officials:
affiliation: Institut Curie
name: Fabien Reyal, MD
role: PRINCIPAL_INVESTIGATOR
References: