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

NCT03529383 | Completed

• 1 other identifier: ET17-203 DISCO
• Study Type: interventional
• Target: 436
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Breast Cancer

Keywords

Localized breast cancer; Exercise; Adapted physical activity; Sedentary; Connected device; Activity trackers; Therapeutic education; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (28)

• 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)

  12 months

• Proportion of patients who are compliant to the programs

  6 months

• Proportion of patients who change their physical activity profile (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)

  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)

  Change between baseline and 6 months and between 6 months and 12 months

Other Outcomes (3)

• Cost-utility of the interventions as assessed using clinical data (treatments received, patients' diary on medical consultations) and hospital costs (national data).

  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.

  12 months

• Assessment of the association between the objective and subjective characteristics of living spaces and patients' PA practices.

  12 months

Study Arms (4)

Connected device

EXPERIMENTAL

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

Therapeutic education

EXPERIMENTAL

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

Combined

EXPERIMENTAL

Women will benefit from both the "connected device" intervention and the "therapeutic education" intervention and receive international recommendations on physical activity.

Device: Connected device; Behavioral: Therapeutic education

Control

NO INTERVENTION

Women will receive standard care, i.e., international recommendations on physical activity, without further intervention.

Interventions

Connected device 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.

Combined; Connected device

Therapeutic education BEHAVIORAL

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.

Combined; Therapeutic education

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

Institut Sainte-Catherine

Avignon, France

Location

CHRU Besançon

Besançon, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Related Publications (11)

• 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.

  PMID: 21935600 BACKGROUND

• 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.

  PMID: 28387544 BACKGROUND

• 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.

  PMID: 26071863 BACKGROUND

• 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.

  PMID: 25890168 BACKGROUND

• 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.

  PMID: 25220842 BACKGROUND

• 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.

  PMID: 20411366 BACKGROUND

• 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.

  PMID: 25752971 BACKGROUND

• 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.

  PMID: 28123997 BACKGROUND

• 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.

  PMID: 27286758 BACKGROUND

• 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.

  PMID: 18562971 BACKGROUND

• 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.

  PMID: 34518245 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Sedentary Behavior; Obesity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Béatrice Fervers, MD, PhD

  Centre Léon Bérard, Lyon, France

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Two interventions, each alone and in combination, are evaluated in parallel against a control group. Women assigned to the "connected device" arm will follow a 6-month exercise program using a connected device. Women assigned to the "therapeutic education" arm will follow a 6-month program of therapeutic patient education in physical activity. Women assigned to the "combined" arm will follow both programs. Women assigned to the "control" arm will receive international recommendations on physical activity.

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: May 18, 2018
• Study Start: May 18, 2018
• Primary Completion: March 4, 2022
• Study Completion: September 23, 2022
• Last Updated: March 22, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)