Ignite Creation Date:
2024-05-06 @ 4:32 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05011721
Status:
RECRUITING
Last Update Posted:
2024-01-29
First Post:
2021-07-19
Brief Title:
Digital Phenotyping in Young Breast Cancer Patients Treated With Neoadjuvant Chemotherapy
Sponsor:
Institut Curie
Organization:
Institut Curie
Study Overview
Official Title:
Digital Phenotyping Physical Activity Heart Rate Sleep in Young Breast Cancer Patients Treated With Neoadjuvant Chemotherapy
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NeoFit
Brief Summary:
NeoFit is a prospective national multicenter single-arm open-label study It will include a total of 300 participants under the age of 70 years treated with neoadjuvant chemotherapy for BC Participants will receive a Withing Steel HR 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 the end of neoadjuvant chemotherapy and at 12 months The investigators will evaluate clinical eg toxicity efficacy of chemotherapy 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 young women breast cancer BC has particular characteristics such as a more advanced stage at diagnosis aggressive tumor characteristics and a poorer prognosis NeoFit aims to use an activity tracker to identify and describe various digital profiles physical activity heart rate sleep in women under 70 years of age treated with neoadjuvant chemotherapy for BC
METHODS NeoFit is a prospective national multicenter single-arm open-label study It will include a total of 300 participants under the age of 70 years treated with neoadjuvant chemotherapy for BC Participants will receive a Withing Steel HR 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 the end of neoadjuvant chemotherapy and at 12 months The investigators will evaluate clinical eg toxicity efficacy of chemotherapy lifestyle quality of life fatigue and physical activity parameters All questionnaires will be completed on a REDCap form via a secure internet link
DISCUSSION NeoFit will make it possible through the use of an activity tracker to visualize changes over a one-year period in the lifestyle of young women treated for BC by neoadjuvant chemotherapy This exploratory study will provide fundamental knowledge about the digital phenotypes of young BC patients treated with NAC and their relationships to chemotherapy toxicity and efficacy This trial will pave the way for interventional studies on physical activity and sleep interventions
METHODS NeoFit is a prospective national multicenter single-arm open-label study It will include a total of 300 participants under the age of 70 years treated with neoadjuvant chemotherapy for BC Participants will receive a Withing Steel HR 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 the end of neoadjuvant chemotherapy and at 12 months The investigators will evaluate clinical eg toxicity efficacy of chemotherapy lifestyle quality of life fatigue and physical activity parameters All questionnaires will be completed on a REDCap form via a secure internet link
DISCUSSION NeoFit will make it possible through the use of an activity tracker to visualize changes over a one-year period in the lifestyle of young women treated for BC by neoadjuvant chemotherapy This exploratory study will provide fundamental knowledge about the digital phenotypes of young BC patients treated with NAC and their relationships to chemotherapy toxicity and efficacy This trial will pave the way for interventional studies on physical activity and sleep interventions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None