Digital Phenotyping in Young Breast Cancer Patients Treated With Neoadjuvant Chemotherapy

NCT05011721 | Completed DMC

• 1 other identifier: IC 2020-20
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer

Keywords

neoadjuvant; digital; prevention; activity tracker

Outcome Measures

Primary Outcomes (4)

• Describe physical activity profiles in breast cancer patients under 70 years of age treated by neoadjuvant chemotherapy

  The activity tracker will register step counts for each day. the investigators will plot the average daily step counts and the 95% confidence interval across the entire study period. Then will will study the change in step count trajectory during the study. Linear mixed model will be used for describing change over time

  Month 12

• Describe heart rate profiles in breast cancer patients under 70 years of age treated by neoadjuvant chemotherapy

  The activity tracker will register heart rate at 10-minute intervals for each day. The investigators will plot the average heart rate frequency and the 95% confidence interval across the entire study period. Then will will study the change in heart rate frequency trajectory during the study. Linear mixed model will be used for describing change over time

  Month 12

• Describe sleep profiles in breast cancer patients under 70 years of age treated by neoadjuvant chemotherapy

  The activity tracker will register sleep duration for each day. The investigators will plot the average sleep duration and the 95% confidence interval across the entire study period. Then will tudy the change in sleep duration trajectory during the study. Linear mixed model will be used for describing change over time

  Month 12

• Identify digital profiles (physical activity, heart rate, sleep) in breast cancer patients under 70 years of age treated by neoadjuvant chemotherapy

  To identify digital profiles, The investigators will combine step counts profiles, heart frequency profiles and sleep profiles using mixed models with latent classes. The use of a mixed model will make it possible to analyze repeat data for the population, and to determine an average profile or trajectory for the whole population. The optimal number of classes will be determined a posteriori, based on a set of statistical and clinical criteria. The most widely used statistical criterion is the "Bayesian information criterion" (BIC), which penalizes the model's likelihood according to its complexity. The BIC, which is stricter than many other criteria, has been shown to have a better performance in simulations. The number of trajectories will also be based on clinical interpretation (whether it is worthwhile retaining classes containing very small numbers of subjects, etc.).

  Month 12

Secondary Outcomes (6)

• Analyze the effects of digital profiles on treatment toxicity

  End of neoadjuvant chemotherapy, Month 12

• Analyze the effects of digital profiles on quality of life

  End of neoadjuvant chemotherapy, Month 12

• Analyze the effects of digital profiles on fatigue

  End of neoadjuvant chemotherapy, Month 12

• Develop models for predicting toxicity during the course of treatment

  End of the neoadjuvant chemotherapy, Month 12

• Develop models for predicting fatigue changes during the course of treatment

  End of the neoadjuvant chemotherapy, Month 12

Study Arms (1)

Intervention with activity tracker

EXPERIMENTAL

Women allocated to the intervention arm will used an activity tracker

Device: Activity tracker

Interventions

Activity tracker 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.

Intervention with activity tracker

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (3)

Institut Curie

Paris, 75005, France

Location

Institut Jean Godinot

Reims, 51100, France

Location

Institut Curie

Saint-Cloud, 92, France

Location

Related Publications (1)

• 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.

  PMID: 35509030 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• Fabien Reyal, MD

  Institut Curie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 18, 2021
• Study Start: September 20, 2021
• Primary Completion: March 3, 2025
• Study Completion: March 3, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR (3)