Efficacy of Exercise Using Connected Activity Trackers and Therapeutic Education in Localized Breast Cancer (DISCO)

Randomized Controlled Trial Evaluating the Efficacy of an Adapted Physical Activity Program Using a Connected Device With Activity Trackers and a Therapeutic Education Program Among Women With Localized Breast Cancer

The 3-year DISCO study aims to systematically implement physical activity in breast cancer patients. The primary objective is to investigate the efficacy of a connected device (personalized non-supervised exercise program including a wristband as activity tracker, a smartphone application, and a website) and the efficacy of a therapeutic education program on the physical activity level of patients at the end of the 6-month programs. The research hypothesis is that patients participating in the intervention with the connected device or in the therapeutic education program will achieve the international recommendations in terms of physical activity, compared to women receiving only physical activity recommendations.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Connected device; Behavioral: Therapeutic education

Detailed Description

Rationale:

In women with breast cancer, weight gain, obesity, and lack of physical activity have been shown to increase the risk of comorbidities and deleterious long-term outcomes. Despite the safety of physical activity and the benefits of physical activity performed concomitant to treatment on fatigue, quality of life, and possibly survival, its implementation is not systematic in the cancer care pathway.

Methods:

The DISCO study is a randomized, controlled, multicenter intervention study that will be conducted among 432 women treated for localized breast cancer. Patients will be randomly assigned to one of the four arms of the study according to a 1:1:1:1 ratio.

• Women allocated to the "connected device" arm will benefit from a 6-month personalized exercise program consisting of three weekly sessions of aerobic and strength exercises, carried out autonomously with a connected device (wristband, smartphone application, website).
• Women allocated to the "therapeutic education" arm will follow a 6-month program of therapeutic patient education.
• Women allocated to the "combined" arm will benefit from both interventions in parallel.
• Women allocated to the "control" arm will receive standard care, i.e., international recommendations on physical activity.

Evaluations will be conducted at inclusion (T1, baseline), 6 months (T2, end of interventions), and 12 months (T3, 12 months post-inclusion to study maintenance of behavior change) on the following parameters: level of physical activity and sedentary behavior (RPAQ self-administered questionnaire), physical condition assessed by functional tests (6-min walking test, sit-to-stand test, hang-grip test, sit-and-reach flexibility test, single-leg balance test), anthropometrics (weight, height, waist circumference, hip circumference, calculated body mass index), body composition (fat mass, lean body mass, fat free mass, water), biological factors (blood sample at baseline and 6 months), lifestyle factors (tobacco status, alcohol intake), psychological factors (quality of life assessed by the EORTC QLQ-C30 / BR-23 questionnaire, health-related quality of life assessed by the EQ-5D-5L questionnaire, fatigue assessed by the PFS-12 questionnaire), socio-economic parameters (social deprivation assessed by the EPICES questionnaire, level of education, family situation, professional status assessed through a self-administered questionnaire). Clinical data will be obtained from patients' medical records. Acceptability of connected device and of therapeutic education program will be assessed within the population. The medico-economic impact of the interventions will be evaluated through cost-utility and cost-effectiveness analyses. Data will be recorded using an e-CRF. Women will be recruited over 2 years and will be followed up for 12 months.

Hypothesis:

The research hypothesis is that patients participating in the 6-month intervention with the connected device or in the 6-month therapeutic education program will be more likely to achieve the international recommendations in terms of physical activity, compared to women receiving only physical activity recommendations.

Expected results are to identify best modalities to implement exercise during and after breast cancer treatment. In a public health perspective, the challenge is to reduce geographical, social, and organizational inequalities among patients to practice regular physical activity and to promote the systematic integration of physical activity in routine cancer care.

• Study Type: Interventional
• Enrollment (Actual): 436
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Avignon, France
    • Institut Sainte-Catherine
  • Besançon, France
    • CHRU Besançon
  • Lyon, France, 69008
    • Centre Léon Bérard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female between 18 and 75 years old,
• Being diagnosed with a first primary non-metastatic invasive breast carcinoma, that has been histologically confirmed,
• Having been operated and requiring the prescription of an adjuvant treatment (chemotherapy, hormonotherapy, radiotherapy),
• Whose adjuvant treatment will be prescribed (for hormone therapy) or carried out (for chemotherapy and radiotherapy) in one of the investigating centers,
• Being able to practice adapted physical activity and providing a medical certificate of no contraindications to exercise issued by the investigator physician, the general practitioner, or the referring physician,
• Available and willing to participate in the study for the duration of the interventions and follow-up,
• Using a personal smartphone compatible with the application (iOS operating system from version 9.3, Android operating system from version 5.0, no Microsoft operating system) and having Internet access on a computer,
• Able to understand, read, and write French,
• Affiliated with a social security scheme,
• Having dated and signed an informed consent.

Exclusion Criteria:

• Woman with recurrent, metastatic, or inflammatory breast cancer,
• Personal history or co-existence of another primary cancer (except of in situ cancer regardless of the site and/or basal cell skin cancer and/or non-mammary cancer in complete remission for more than 5 years),
• Presenting a contraindication to exercise according to the investigator (such as cardiorespiratory or bone pathologies, non-stabilized chronic diseases such as diabetes, malnutrition, etc.),
• In a state of severe malnutrition according to the criteria of the French National Health Authority (i.e., in women ≤ 70 years: weight loss ≥ 15% in 6 months or ≥ 10% in 1 month; in women > 70 years: weight loss ≥ 15% in 6 months or ≥ 10% in 1 month, and body mass index < 18 kg/m²),
• Unable to be followed for medical, social, family, geographic or psychological reasons for the duration of the study,
• Participating in simultaneous physical activity studies,
• Deprived of their liberty by court or administrative decision,
• Pregnant or breastfeeding or of childbearing age without effective contraception for the duration of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Connected device; Women randomized to the "connected device" arm will follow a 6-month exercise program using a connected device that includes an activity tracker and subscription to an exercise and physical activity management program through a smartphone application and a website. They will also receive international recommendations on physical activity.	Device: Connected device; Women will receive a connected wristband (https://www.carefitness.com/) and a subscription to a smartphone application and website (http://disco.biomouv.com/). They will have to participate in a 6-month personalized non-supervised exercise program consisting of 3 weekly sessions of 20 min to 1-hr of moderate-to-vigorous physical activity (≥3 METs): 2 sessions of brisk walking and 1 session of muscle strengthening. Women should wear the wristband daily to track their number of steps (automatic Bluetooth synchronization to the application). Duration and intensity of sessions and target number of daily steps will progressively increase (+15% up to 10,000 steps) to place the patients in a progression dynamic. Women will receive phone-based follow-up at 1 week, 2 months, and 4 months.
Experimental: Therapeutic education; Women randomized to the "therapeutic education" arm will follow a 6-month program of therapeutic patient education. They will also receive international recommendations on physical activity.	Behavioral: Therapeutic education; Women will be invited to participate in the 6-month therapeutic patient education program "Mieux manger, mieux bouger" ("Eat better, move better") elaborated at the Léon Bérard cancer center. The program consists in four sessions: a 1-hour individual session of "educational diagnosis" to assess their needs and establish a contract of objectives,; two "educational sessions" of 1h30 each using tools, in group of 10 patients maximum to improve their daily practice of physical activity,; a 1-hour individual session of "educational assessment" to evaluate whether their objectives were reached.
Experimental: Combined; Women will benefit from both the "connected device" intervention and the "therapeutic education" intervention and receive international recommendations on physical activity.	Device: Connected device; Women will receive a connected wristband (https://www.carefitness.com/) and a subscription to a smartphone application and website (http://disco.biomouv.com/). They will have to participate in a 6-month personalized non-supervised exercise program consisting of 3 weekly sessions of 20 min to 1-hr of moderate-to-vigorous physical activity (≥3 METs): 2 sessions of brisk walking and 1 session of muscle strengthening. Women should wear the wristband daily to track their number of steps (automatic Bluetooth synchronization to the application). Duration and intensity of sessions and target number of daily steps will progressively increase (+15% up to 10,000 steps) to place the patients in a progression dynamic. Women will receive phone-based follow-up at 1 week, 2 months, and 4 months.; Behavioral: Therapeutic education; Women will be invited to participate in the 6-month therapeutic patient education program "Mieux manger, mieux bouger" ("Eat better, move better") elaborated at the Léon Bérard cancer center. The program consists in four sessions: a 1-hour individual session of "educational diagnosis" to assess their needs and establish a contract of objectives,; two "educational sessions" of 1h30 each using tools, in group of 10 patients maximum to improve their daily practice of physical activity,; a 1-hour individual session of "educational assessment" to evaluate whether their objectives were reached.
No Intervention: Control; Women will receive standard care, i.e., international recommendations on physical activity, without further intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients achieving the internationally recommended level of physical activity of at least 150 minutes per week of moderate-to-vigorous physical activity (intensity ≥3 METs)	Assessed by the RPAQ self-administered questionnaire	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients achieving the internationally recommended level of physical activity of at least 150 minutes per week of moderate-to-vigorous physical activity (intensity ≥3 METs)	Assessed by the RPAQ self-administered questionnaire	12 months
Proportion of patients who are compliant to the programs	Participation rate in planned sessions	6 months
Proportion of patients who change their physical activity profile (Time spent in different intensities of physical activity, time spent in sedentary activities)	Time spent in different intensities of physical activity, time spent in sedentary activities	Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their physical condition (6-min walking test)	6-min walking test	Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their physical condition (Sit to stand test)	Sit to stand test	Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their physical condition (Hand-grip test)	Hand-grip test	Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their physical condition (sit-and-reach flexibility test)	sit-and-reach flexibility test	Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their physical condition	single-leg balance test	Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their weight	Weight in kilograms	Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their waist circumference	Waist circumference in cms	Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their hip circumference	Hip circumference in cms	Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their BMI	weight in kilograms and height in meters will be combined to report BMI in kg/m^2	Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their fat mass in body composition	fat mass measured using bioelectronic impedancemetry	Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their lean body mass in body composition	lean body mass measured using bioelectronic impedancemetry	Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their fat free mass in body composition	fat free mass measured using bioelectronic impedancemetry	Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their water in body composition	water measured using bioelectronic impedancemetry	Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their tobacco use	Self-administered questionnaire	Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their alcohol intake	Self-administered questionnaire	Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients with a change in quality of life	EORTC QLQ-C30 questionnaire and its BR-23 module	Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients with a change in fatigue condition	PFS-12 questionnaire	Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients with a change in health-related quality of life	EQ-5D-5L questionnaire	Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who modify their professional status	Change in professional status, return to work, and perceived difficulty at work by a self-administered questionnaire.	Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients with a modification on serum circulating levels of endocrine factors (insulin, IGF1, estradiol)	Blood sample	Change between Day 0 and 6 months
Proportion of patients with a modification on plasma circulating levels of cytokines (inflammatory cytokines: IL-6, TNF, and CRP; adipokines: adiponectin and leptin)	Blood sample	Change between Day 0 and 6 months
Proportion of patients with a modification on vitamin D status	Blood sample	Change between Day 0 and 6 months
Number of patients who accept the connected device	Self-administered qualitative questionnaire used in social psychology science	Baseline, 6 months and 12 months
Number of patients who accept the therapeutic program	self-administered qualitative questionnaire used in social psychology science	Baseline, 6 months and 12 months
Proportion of patients who refuse to participate	Refusal rate among eligible patients to whom the study was presented	Baseline (day 0)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-utility of the interventions as assessed using clinical data (treatments received, patients' diary on medical consultations) and hospital costs (national data).	The cost-utility of implementing each intervention will be assessed.	12 months
Cost-effectiveness of the interventions as assessed using clinical data (treatments received, patients' diary on medical consultations), hospital costs (national data), and benefit in physical activity level.	The cost-effectiveness of implementing each intervention will be assessed.	12 months
Assessment of the association between the objective and subjective characteristics of living spaces and patients' PA practices.	ALPHA questionnaire	12 months

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Collaborators: National Cancer Institute, France; Fondation ARC; Fondation pour la Recherche Médicale; Cancéropôle Lyon Auvergne Rhône-Alpes; AG2R La Mondiale

Publications and helpful links

General Publications

• Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
• Beg MS, Gupta A, Stewart T, Rethorst CD. Promise of Wearable Physical Activity Monitors in Oncology Practice. J Oncol Pract. 2017 Feb;13(2):82-89. doi: 10.1200/JOP.2016.016857.
• Ibrahim EM, Al-Homaidh A. Physical activity and survival after breast cancer diagnosis: meta-analysis of published studies. Med Oncol. 2011 Sep;28(3):753-65. doi: 10.1007/s12032-010-9536-x. Epub 2010 Apr 22.
• Sullivan AN, Lachman ME. Behavior Change with Fitness Technology in Sedentary Adults: A Review of the Evidence for Increasing Physical Activity. Front Public Health. 2017 Jan 11;4:289. doi: 10.3389/fpubh.2016.00289. eCollection 2016.
• Lahart IM, Metsios GS, Nevill AM, Carmichael AR. Physical activity, risk of death and recurrence in breast cancer survivors: A systematic review and meta-analysis of epidemiological studies. Acta Oncol. 2015 May;54(5):635-54. doi: 10.3109/0284186X.2014.998275. Epub 2015 Mar 9.
• Tudor-Locke C, Hatano Y, Pangrazi RP, Kang M. Revisiting "how many steps are enough?". Med Sci Sports Exerc. 2008 Jul;40(7 Suppl):S537-43. doi: 10.1249/MSS.0b013e31817c7133.
• Beasley JM, Kwan ML, Chen WY, Weltzien EK, Kroenke CH, Lu W, Nechuta SJ, Cadmus-Bertram L, Patterson RE, Sternfeld B, Shu XO, Pierce JP, Caan BJ. Meeting the physical activity guidelines and survival after breast cancer: findings from the after breast cancer pooling project. Breast Cancer Res Treat. 2012 Jan;131(2):637-43. doi: 10.1007/s10549-011-1770-1. Epub 2011 Sep 21.
• Cadmus-Bertram LA, Marcus BH, Patterson RE, Parker BA, Morey BL. Randomized Trial of a Fitbit-Based Physical Activity Intervention for Women. Am J Prev Med. 2015 Sep;49(3):414-8. doi: 10.1016/j.amepre.2015.01.020. Epub 2015 Jun 10.
• Ferguson T, Rowlands AV, Olds T, Maher C. The validity of consumer-level, activity monitors in healthy adults worn in free-living conditions: a cross-sectional study. Int J Behav Nutr Phys Act. 2015 Mar 27;12:42. doi: 10.1186/s12966-015-0201-9.
• Thariat J, Creisson A, Chamignon B, Dejode M, Gastineau M, Hebert C, Boissin F, Topfer C, Gilbert E, Grondin B, Guennoc H, Mari V, Buzzo S, Saja D, Duboue N, Boulahssass R, Tosi A, Verne S, Ducray J, Benard-Thiery I, Ferrero JM. [Integrating patient education in your oncology practice]. Bull Cancer. 2016 Jul-Aug;103(7-8):674-90. doi: 10.1016/j.bulcan.2016.04.007. Epub 2016 Jun 7. French.
• Touillaud M, Fournier B, Perol O, Delrieu L, Maire A, Belladame E, Perol D, Perrier L, Preau M, Leroy T, Fassier JB, Fillol F, Pascal S, Durand T, Fervers B. Connected device and therapeutic patient education to promote physical activity among women with localised breast cancer (DISCO trial): protocol for a multicentre 2x2 factorial randomised controlled trial. BMJ Open. 2021 Sep 13;11(9):e045448. doi: 10.1136/bmjopen-2020-045448.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2018
• Primary Completion (Actual): March 4, 2022
• Study Completion (Actual): September 23, 2022

Study Registration Dates

• First Submitted: April 13, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (Actual): May 18, 2018

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Exercise; Obesity; Sedentary; Therapeutic education; Localized breast cancer; Adapted physical activity; Connected device; Activity trackers
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ET17-203 DISCO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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