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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529383
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : January 13, 2020
Sponsor:
Collaborators:
Fondation ARC
National Cancer Institute, France
Fondation pour la Recherche Médicale
Cancéropôle Lyon Auvergne Rhône-Alpes
AG2R La Mondiale
Information provided by (Responsible Party):
Centre Leon Berard

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Connected device Behavioral: Therapeutic education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : May 18, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


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" (in the month following randomization in the study) to assess their needs and establish a contract of objectives,
  • two "educational sessions" of 1h30 each using tools, in group of 10 patients maximum (between months 2 and 4) to improve their daily practice of physical activity,
  • a 1-hour individual session of "educational assessment" (month 5 to 6) 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" (in the month following randomization in the study) to assess their needs and establish a contract of objectives,
  • two "educational sessions" of 1h30 each using tools, in group of 10 patients maximum (between months 2 and 4) to improve their daily practice of physical activity,
  • a 1-hour individual session of "educational assessment" (month 5 to 6) 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.



Primary Outcome Measures :
  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) [ Time Frame: 6 months ]
    Assessed by the RPAQ self-administered questionnaire


Secondary Outcome Measures :
  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) [ Time Frame: 12 months ]
    Assessed by the RPAQ self-administered questionnaire

  2. Proportion of patients who are compliant to the programs [ Time Frame: 6 months ]
    Participation rate in planned sessions

  3. Proportion of patients who change their physical activity profile (Time spent in different intensities of physical activity, time spent in sedentary activities) [ Time Frame: Change between baseline and 6 months and between 6 months and 12 months ]
    Time spent in different intensities of physical activity, time spent in sedentary activities

  4. Proportion of patients who change their physical condition (6-min walking test) [ Time Frame: Change between baseline and 6 months and between 6 months and 12 months ]
    6-min walking test

  5. Proportion of patients who change their physical condition (Sit to stand test) [ Time Frame: Change between baseline and 6 months and between 6 months and 12 months ]
    Sit to stand test

  6. Proportion of patients who change their physical condition (Hand-grip test) [ Time Frame: Change between baseline and 6 months and between 6 months and 12 months ]
    Hand-grip test

  7. Proportion of patients who change their physical condition (sit-and-reach flexibility test) [ Time Frame: Change between baseline and 6 months and between 6 months and 12 months ]
    sit-and-reach flexibility test

  8. Proportion of patients who change their physical condition [ Time Frame: Change between baseline and 6 months and between 6 months and 12 months ]
    single-leg balance test

  9. Proportion of patients who change their weight [ Time Frame: Change between baseline and 6 months and between 6 months and 12 months ]
    Weight in kilograms

  10. Proportion of patients who change their waist circumference [ Time Frame: Change between baseline and 6 months and between 6 months and 12 months ]
    Waist circumference in cms

  11. Proportion of patients who change their hip circumference [ Time Frame: Change between baseline and 6 months and between 6 months and 12 months ]
    Hip circumference in cms

  12. Proportion of patients who change their BMI [ Time Frame: Change between baseline and 6 months and between 6 months and 12 months ]
    weight in kilograms and height in meters will be combined to report BMI in kg/m^2

  13. Proportion of patients who change their fat mass in body composition [ Time Frame: Change between baseline and 6 months and between 6 months and 12 months ]
    fat mass measured using bioelectronic impedancemetry

  14. Proportion of patients who change their lean body mass in body composition [ Time Frame: Change between baseline and 6 months and between 6 months and 12 months ]
    lean body mass measured using bioelectronic impedancemetry

  15. Proportion of patients who change their fat free mass in body composition [ Time Frame: Change between baseline and 6 months and between 6 months and 12 months ]
    fat free mass measured using bioelectronic impedancemetry

  16. Proportion of patients who change their water in body composition [ Time Frame: Change between baseline and 6 months and between 6 months and 12 months ]
    water measured using bioelectronic impedancemetry

  17. Proportion of patients who change their tobacco use [ Time Frame: Change between baseline and 6 months and between 6 months and 12 months ]
    Self-administered questionnaire

  18. Proportion of patients who change their alcohol intake [ Time Frame: Change between baseline and 6 months and between 6 months and 12 months ]
    Self-administered questionnaire

  19. Proportion of patients with a change in quality of life [ Time Frame: Change between baseline and 6 months and between 6 months and 12 months ]
    EORTC QLQ-C30 questionnaire and its BR-23 module

  20. Proportion of patients with a change in fatigue condition [ Time Frame: Change between baseline and 6 months and between 6 months and 12 months ]
    PFS-12 questionnaire

  21. Proportion of patients with a change in health-related quality of life [ Time Frame: Change between baseline and 6 months and between 6 months and 12 months ]
    EQ-5D-5L questionnaire

  22. Proportion of patients who modify their professional status [ Time Frame: Change between baseline and 6 months and between 6 months and 12 months ]
    Change in professional status, return to work, and perceived difficulty at work by a self-administered questionnaire.

  23. Proportion of patients with a modification on serum circulating levels of endocrine factors (insulin, IGF1, estradiol) [ Time Frame: Change between Day 0 and 6 months ]
    Blood sample

  24. Proportion of patients with a modification on plasma circulating levels of cytokines (inflammatory cytokines: IL-6, TNF, and CRP; adipokines: adiponectin and leptin) [ Time Frame: Change between Day 0 and 6 months ]
    Blood sample

  25. Proportion of patients with a modification on vitamin D status [ Time Frame: Change between Day 0 and 6 months ]
    Blood sample

  26. Number of patients who accept the connected device [ Time Frame: Baseline, 6 months and 12 months ]
    Self-administered qualitative questionnaire used in social psychology science

  27. Number of patients who accept the therapeutic program [ Time Frame: Baseline, 6 months and 12 months ]
    self-administered qualitative questionnaire used in social psychology science

  28. Proportion of patients who refuse to participate [ Time Frame: Baseline (day 0) ]
    Refusal rate among eligible patients to whom the study was presented


Other Outcome Measures:
  1. Cost-utility of the interventions as assessed using clinical data (treatments received, patients' diary on medical consultations) and hospital costs (national data). [ Time Frame: 12 months ]
    The cost-utility of implementing each intervention will be assessed.

  2. 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. [ Time Frame: 12 months ]
    The cost-effectiveness of implementing each intervention will be assessed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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),
  • Followed-up 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,
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529383


Contacts
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Contact: Marina Touillaud, PhD +33 (0)4 69 16 66 44 marina.touillaud@lyon.unicancer.fr
Contact: Aurélia Maire, MS +33 (0)4 69 85 62 18 aurelia.maire@lyon.unicancer.fr

Locations
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France
Centre Léon Bérard Recruiting
Lyon, France, 69008
Contact: Marina Touillaud, PhD    +33 (0)4 69 16 66 44    marina.touillaud@lyon.unicancer.fr   
Contact: Aurélia Maire, MS    +33 (0)4 69 85 62 18    aurelia.maire@lyon.unicancer.fr   
Principal Investigator: Béatrice Fervers, MD, PhD         
Sponsors and Collaborators
Centre Leon Berard
Fondation ARC
National Cancer Institute, France
Fondation pour la Recherche Médicale
Cancéropôle Lyon Auvergne Rhône-Alpes
AG2R La Mondiale
Investigators
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Principal Investigator: Béatrice Fervers, MD, PhD Centre Léon Bérard, Lyon, France
Publications:

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Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT03529383    
Other Study ID Numbers: ET17-203 DISCO
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Leon Berard:
Localized breast cancer
Exercise
Adapted physical activity
Sedentary
Connected device
Activity trackers
Therapeutic education
Obesity
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases