Trial Title:
Digital Phenotyping in Women Over 70 Years of Age Treated for Breast Cancer With Any Type of Treatment
NCT ID:
NCT05634395
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
digital
activity tracker
lifestyle
prevention
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Activity tracker
Description:
Participants will receive a Withings Steel activity tracker (Withings,
Issy-les-Moulineaux, France), which they will be asked to wear 24 hours per day
throughout the whole intervention (12 months). At baseline, the Withings Health Mate
mobile phone application will be downloaded onto each participant's smartphone or tablet.
The clinical research assistant will instruct the participant in the use of the activity
tracker. The participant will then accept and activate the sharing of the data collected
with the secure server dedicated to the "GrannyFit" study at the Institut Curie.
Participants will be asked to synchronize the activity tracker regularly (ideally daily)
via Bluetooth with the Withings Health Mate application, for automatic transfer of the
data to the secure "GrannyFit" space.
Arm group label:
Intervention with activity tracker
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.
Criteria for 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,
Gender:
Female
Minimum age:
70 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Zip:
69008
Country:
France
Status:
Recruiting
Contact:
Last name:
Catherine TERRET
Email:
catherine.terret@lyon.unicancer.fr
Investigator:
Last name:
Catherine TERRET, MD
Email:
Principal Investigator
Facility:
Name:
Institut Curie
Address:
City:
Paris
Zip:
75005
Country:
France
Status:
Recruiting
Contact:
Last name:
Fabien Reyal, MD
Phone:
+33144324660
Email:
fabien.reyal@curie.fr
Contact backup:
Last name:
Jean-Guillaume Feron, MD
Email:
jeanguillaume.feron@curie.fr
Facility:
Name:
Institut GODINOT
Address:
City:
Reims
Zip:
51100
Country:
France
Status:
Recruiting
Contact:
Last name:
Christelle JOUANNAUD, MD
Email:
christelle.jouannaud@reims.unicancer.fr
Investigator:
Last name:
Christelle JOUANNAUD, MD
Email:
Principal Investigator
Facility:
Name:
Institut Curie
Address:
City:
Saint-Cloud
Zip:
92210
Country:
France
Status:
Recruiting
Contact:
Last name:
Florence LEREBOURS, MD
Email:
florence.lerebours@curie.fr
Investigator:
Last name:
Florence LEREBOURS
Email:
Principal Investigator
Start date:
February 17, 2023
Completion date:
May 13, 2026
Lead sponsor:
Agency:
Institut Curie
Agency class:
Other
Source:
Institut Curie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05634395
