Digital Phenotyping in Young Breast Cancer Patients Treated With Neoadjuvant Chemotherapy

NCT ID: NCT05011721

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-20
• Study Completion Date: 2025-03-03

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 (e.g. 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 (e.g. 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention with activity tracker

Women allocated to the intervention arm will used an activity tracker

Group Type: EXPERIMENTAL

Activity tracker

Intervention Type: DEVICE

Participants will receive a Withings Steel HR 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 "NeoFit" 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 "NeoFit" space.

Interventions

Activity tracker

Participants will receive a Withings Steel HR 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 "NeoFit" 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 "NeoFit" space.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• female
• ≥ 18 years old and <70 years old
• histologically confirmed BC, whatever the histological subtype (hormone receptor positive (RH+), negative (RH-), with (HER2+) overexpression or without (HER2-) HER2 overexpression, or triple negative)
• planned NAC (up to the day of the first neoadjuvant chemotherapy treatment)
• Eastern Cooperative Oncology Group Performance status ≤2
• willing to participate for the entire duration of the study
• ability to use a compatible smartphone or Tablet PC to download the application Withings Health Mate (from iOS 10 and Android 5.0 or above)
• Internet access
• valid health insurance
• able to read, write and understand French

Exclusion Criteria

• presence of metastases
• Presence of bilateral breast cancer
• a history of cancer other than basal cell skin lesions and cervical dysplasia
• pregnancy, likelihood of pregnancy, or breastfeeding
• impossibility of follow-up throughout the study for medical, social, family, geographic or psychological reasons
• deprived of liberty through a judicial or administrative decision.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Curie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabien Reyal, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Curie

Locations

Institut Curie

Paris, , France

Institut Jean Godinot

Reims, , France

Institut Curie

Saint-Cloud, , France

Countries

France

References

Delrieu L, Hamy AS, Coussy F, Kassara A, Asselain B, Antero J, De Villele P, Dumas E, Forstmann N, Guerin J, Hotton J, Jouannaud C, Milder M, Leopold A, Sedeaud A, Soibinet P, Toussaint JF, Vercamer V, Laas E, Reyal F. Digital phenotyping in young breast cancer patients treated with neoadjuvant chemotherapy (the NeoFit Trial): protocol for a national, multicenter single-arm trial. BMC Cancer. 2022 May 4;22(1):493. doi: 10.1186/s12885-022-09608-y.

Reference Type: BACKGROUND

PMID: 35509030 (View on PubMed)

Other Identifiers

IC 2020-20

Identifier Type: -

Identifier Source: org_study_id