Digital Phenotyping in Young Breast Cancer Patients Treated With Neoadjuvant Chemotherapy (NeoFit)

Digital Phenotyping (Physical Activity, Heart Rate, Sleep) in Young Breast Cancer Patients Treated With Neoadjuvant Chemotherapy

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Activity tracker

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabien Reyal, MD; Phone Number: +33144324660; Email: fabien.reyal@curie.fr
• Study Contact Backup: Name: Jean-Guillaume Feron, MD

Study Locations

• France
  • Paris, France, 75005
    • Recruiting
    • Institut Curie
    • Contact: Fabien Reyal, MD; Email: fabien.reyal@curie.fr
    • Contact: Jean-Guillaume Feron, MD; Email: jeanguillaume.feron@curie.fr
  • Reims, France, 51100
    • Recruiting
    • Institut Jean Godinot
    • Contact: Fabien REYAL, MD; Phone Number: 03 26 50 44 44; Email: fabien.reyal@reims.unicancer.fr
    • Principal Investigator: Fabien REYNAL, MD
  • Saint-Cloud, France, 92
    • Recruiting
    • Institut Curie
    • Contact: Florence LEREBOURS, MD; Phone Number: 01 47 11 15 15; Email: florence.lerebours@curie.fr
    • Principal Investigator: Florence LEREBOURS, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention with activity tracker; Women allocated to the intervention arm will used an activity tracker

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analyze the effects of digital profiles on treatment toxicity	Occurence of severe toxicity (grade >2) according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) Tests will be performed to compare means (Student's t test), or categorical variables (chi2test). The investigators will also perform multinomial logistic regression analyses with univariate and multivariate models, to determine the probability of belonging to a class relative to the corresponding reference class	End of neoadjuvant chemotherapy, Month 12
Analyze the effects of digital profiles on quality of life	Quality of life will be assessed with the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30) Quality of Life Questionnaire (EORTC QLQ-C30) version 3 validated in 2000, a multidimensional questionnaire validated for use with cancer patients. The QLQC30 questionnaire contains 30 items assessing five functional domains (physical, role, emotional, cognitive, and social), one overall quality-of-life domain, three symptom domains (pain, fatigue and nausea), and six individual items (dyspnea, insomnia, anorexia, diarrhea, constipation, and financial impact). Participants will respond on a Likert scale ranging from "not at all" to "very much" and from "very poor" to "excellent" for the overall quality-of-life questions only. Scores will be standardized on a scale of 0 to 100, according to the EORTC scoring manual. Higher scores correspond to better functioning, a better overall quality of life and more symptoms.	End of neoadjuvant chemotherapy, Month 12
Analyze the effects of digital profiles on fatigue	The multidimensional aspects of fatigue will be evaluated with the EORTC QLQ-FA12 version 1 module, which was validated for cancer-related fatigue in 2017. EORTC QLQ-FA12 contains 12 items assessing the physical, cognitive, and emotional domains of cancer-related fatigue. Participants will complete a four-point Likert-scale questionnaire, with responses ranging from "not at all" to "very much". All scores will be transformed to a scale of 0 to 100, with higher scores indicating a greater degree of fatigue. The estimated completion time for this questionnaire is five minutes. Tests will be performed to compare means (Student's t test), or categorical variables (chi2test). The investigators will also perform multinomial logistic regression analyses with univariate and multivariate models, to determine the probability of belonging to a class relative to the corresponding reference class	End of neoadjuvant chemotherapy, Month 12
Develop models for predicting toxicity during the course of treatment	The prediction of treatment toxicity will be assessed by CTCAE v4.0.	End of the neoadjuvant chemotherapy, Month 12
Develop models for predicting fatigue changes during the course of treatment	The prediction of fatigue will be assessed by change from baseline in fatigue scores on FA12 questionnaire and at the end of the neoadjuvant chemotherapy and at 12 months..	End of the neoadjuvant chemotherapy, Month 12
Develop models for predicting quality of life changes during the course of treatment	The prediction of a deterioration of the quality of life will be assessed by change in the global score in EORTC QLQC30 questionnaire from baseline and at the end of the neoadjuvant chemotherapy and at 12 months..	End of the neoadjuvant chemotherapy, Month 12

Collaborators and Investigators

• Sponsor: Institut Curie
• Investigators: Principal Investigator: Fabien Reyal, MD, Institut Curie

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: neoadjuvant; prevention; activity tracker; digital
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IC 2020-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• IPD Sharing 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No