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

Breast Cancer Clinical Trial

— DISCO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03529383
• Other study ID #: ET17-203 DISCO
• Status: Completed
• Phase: N/A
• Start date: May 18, 2018
• Est. completion date: September 23, 2022

Study information

• Verified date: July 2022
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 436
• Est. completion date: September 23, 2022
• Est. primary completion date: March 4, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Female between 18 and 75 years old,
• Being diagnosed with a first primary non-metastatic invasive breast carcinoma, that has been histologically con?rmed,
• 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 certi?cate 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Institut Sainte-Catherine	Avignon
France	CHRU Besançon	Besançon
France	Centre Léon Bérard	Lyon

Sponsors (6)

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

Country where clinical trial is conducted

France, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Assessment of the association between the objective and subjective characteristics of living spaces and patients' PA practices.	ALPHA questionnaire	12 months
Primary	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	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
Secondary	Proportion of patients who are compliant to the programs	Participation rate in planned sessions	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportion of patients who change their weight	Weight in kilograms	Change between baseline and 6 months and between 6 months and 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportion of patients who change their tobacco use	Self-administered questionnaire	Change between baseline and 6 months and between 6 months and 12 months
Secondary	Proportion of patients who change their alcohol intake	Self-administered questionnaire	Change between baseline and 6 months and between 6 months and 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportion of patients with a modification on vitamin D status	Blood sample	Change between Day 0 and 6 months
Secondary	Number of patients who accept the connected device	Self-administered qualitative questionnaire used in social psychology science	Baseline, 6 months and 12 months
Secondary	Number of patients who accept the therapeutic program	self-administered qualitative questionnaire used in social psychology science	Baseline, 6 months and 12 months
Secondary	Proportion of patients who refuse to participate	Refusal rate among eligible patients to whom the study was presented	Baseline (day 0)