Clinical trial NCT03529383: Efficacy of Exercise Using Connected Activity Trackers and Therapeutic Education in Localized Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Localized breast cancer
Exercise
Adapted physical activity
Sedentary
Connected device
Activity trackers
Therapeutic education
Obesity
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
Collaborators: name: Fondation ARC
name: National Cancer Institute, France
name: Fondation pour la Recherche Médicale
name: Cancéropôle Lyon Auvergne Rhône-Alpes
name: AG2R La Mondiale
First posted: 2018-05-18
Enrollment: 436
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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),
* 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.

Primary outcomes:
measure: 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)
timeFrame: 6 months
Secondary outcomes:
measure: 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)
timeFrame: 12 months
measure: Proportion of patients who are compliant to the programs
timeFrame: 6 months
measure: Proportion of patients who change their physical activity profile (Time spent in different intensities of physical activity, time spent in sedentary activities)
timeFrame: Change between baseline and 6 months and between 6 months and 12 months
measure: Proportion of patients who change their physical condition (6-min walking test)
timeFrame: Change between baseline and 6 months and between 6 months and 12 months
measure: Proportion of patients who change their physical condition (Sit to stand test)
timeFrame: Change between baseline and 6 months and between 6 months and 12 months
measure: Proportion of patients who change their physical condition (Hand-grip test)
timeFrame: Change between baseline and 6 months and between 6 months and 12 months
measure: Proportion of patients who change their physical condition (sit-and-reach flexibility test)
timeFrame: Change between baseline and 6 months and between 6 months and 12 months
measure: Proportion of patients who change their physical condition
timeFrame: Change between baseline and 6 months and between 6 months and 12 months
measure: Proportion of patients who change their weight
timeFrame: Change between baseline and 6 months and between 6 months and 12 months
measure: Proportion of patients who change their waist circumference
timeFrame: Change between baseline and 6 months and between 6 months and 12 months
measure: Proportion of patients who change their hip circumference
timeFrame: Change between baseline and 6 months and between 6 months and 12 months
measure: Proportion of patients who change their BMI
timeFrame: Change between baseline and 6 months and between 6 months and 12 months
measure: Proportion of patients who change their fat mass in body composition
timeFrame: Change between baseline and 6 months and between 6 months and 12 months
measure: Proportion of patients who change their lean body mass in body composition
timeFrame: Change between baseline and 6 months and between 6 months and 12 months
measure: Proportion of patients who change their fat free mass in body composition
timeFrame: Change between baseline and 6 months and between 6 months and 12 months
measure: Proportion of patients who change their water in body composition
timeFrame: Change between baseline and 6 months and between 6 months and 12 months
measure: Proportion of patients who change their tobacco use
timeFrame: Change between baseline and 6 months and between 6 months and 12 months
measure: Proportion of patients who change their alcohol intake
timeFrame: Change between baseline and 6 months and between 6 months and 12 months
measure: Proportion of patients with a change in quality of life
timeFrame: Change between baseline and 6 months and between 6 months and 12 months
measure: Proportion of patients with a change in fatigue condition
timeFrame: Change between baseline and 6 months and between 6 months and 12 months
measure: Proportion of patients with a change in health-related quality of life
timeFrame: Change between baseline and 6 months and between 6 months and 12 months
measure: Proportion of patients who modify their professional status
timeFrame: Change between baseline and 6 months and between 6 months and 12 months
measure: Proportion of patients with a modification on serum circulating levels of endocrine factors (insulin, IGF1, estradiol)
timeFrame: Change between Day 0 and 6 months
measure: Proportion of patients with a modification on plasma circulating levels of cytokines (inflammatory cytokines: IL-6, TNF, and CRP; adipokines: adiponectin and leptin)
timeFrame: Change between Day 0 and 6 months
measure: Proportion of patients with a modification on vitamin D status
timeFrame: Change between Day 0 and 6 months
measure: Number of patients who accept the connected device
timeFrame: Baseline, 6 months and 12 months
measure: Number of patients who accept the therapeutic program
timeFrame: Baseline, 6 months and 12 months
measure: Proportion of patients who refuse to participate
timeFrame: Baseline (day 0)
Other outcomes:
measure: Cost-utility of the interventions as assessed using clinical data (treatments received, patients' diary on medical consultations) and hospital costs (national data).
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
measure: Assessment of the association between the objective and subjective characteristics of living spaces and patients' PA practices.
timeFrame: 12 months
Locations:
city: Avignon
country: France
facility: Institut Sainte-Catherine
city: Besançon
country: France
facility: CHRU Besançon
city: Lyon
country: France
facility: Centre Léon Bérard
Study officials:
affiliation: Centre Léon Bérard, Lyon, France
name: Béatrice Fervers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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