Efficacy of Exercise Using Connected Activity Trackers and Therapeutic Education in Localized Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

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.
    

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.
    

Intervention name(s): Connected device; Therapeutic education
Intervention type(s): Device; Behavioral
Intervention description(s): 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.; 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.
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
Keywords: Localized breast cancer; Exercise; Adapted physical activity; Sedentary; Connected device; Activity trackers; Therapeutic education; Obesity