Efficacy of Exercise Using Connected Activity Trackers and Therapeutic Education in Localized Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Device: Connected deviceBehavioral: Therapeutic education
- Registration Number
- NCT03529383
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 436
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Combined Therapeutic education Women will benefit from both the "connected device" intervention and the "therapeutic education" intervention and receive international recommendations on physical activity. Combined Connected device Women will benefit from both the "connected device" intervention and the "therapeutic education" intervention and receive international recommendations on physical activity. Connected device 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. Therapeutic education 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.
- Primary Outcome Measures
Name Time Method 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) 6 months Assessed by the RPAQ self-administered questionnaire
- Secondary Outcome Measures
Name Time Method Proportion of patients who change their physical condition (Hand-grip test) Change between baseline and 6 months and between 6 months and 12 months Hand-grip test
Proportion of patients who change their physical condition (sit-and-reach flexibility test) Change between baseline and 6 months and between 6 months and 12 months sit-and-reach flexibility test
Proportion of patients who change their waist circumference Change between baseline and 6 months and between 6 months and 12 months Waist circumference in cms
Proportion of patients who change their BMI 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
Proportion of patients with a modification on plasma circulating levels of cytokines (inflammatory cytokines: IL-6, TNF, and CRP; adipokines: adiponectin and leptin) Change between Day 0 and 6 months Blood sample
Number of patients who accept the therapeutic program Baseline, 6 months and 12 months self-administered qualitative questionnaire used in social psychology science
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 Time spent in different intensities of physical activity, time spent in sedentary activities
Proportion of patients who change their lean body mass in body composition Change between baseline and 6 months and between 6 months and 12 months lean body mass measured using bioelectronic impedancemetry
Proportion of patients who change their tobacco use Change between baseline and 6 months and between 6 months and 12 months Self-administered questionnaire
Proportion of patients who change their alcohol intake Change between baseline and 6 months and between 6 months and 12 months Self-administered questionnaire
Proportion of patients with a change in health-related quality of life Change between baseline and 6 months and between 6 months and 12 months EQ-5D-5L questionnaire
Proportion of patients with a modification on serum circulating levels of endocrine factors (insulin, IGF1, estradiol) Change between Day 0 and 6 months Blood sample
Proportion of patients who refuse to participate Baseline (day 0) Refusal rate among eligible patients to whom the study was presented
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 Assessed by the RPAQ self-administered questionnaire
Proportion of patients who are compliant to the programs 6 months Participation rate in planned sessions
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 6-min walking test
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 Sit to stand test
Proportion of patients who change their fat mass in body composition Change between baseline and 6 months and between 6 months and 12 months fat mass measured using bioelectronic impedancemetry
Proportion of patients who change their fat free mass in body composition Change between baseline and 6 months and between 6 months and 12 months fat free mass measured using bioelectronic impedancemetry
Proportion of patients with a modification on vitamin D status Change between Day 0 and 6 months Blood sample
Proportion of patients who change their physical condition Change between baseline and 6 months and between 6 months and 12 months single-leg balance test
Proportion of patients who change their weight Change between baseline and 6 months and between 6 months and 12 months Weight in kilograms
Proportion of patients who change their hip circumference Change between baseline and 6 months and between 6 months and 12 months Hip circumference in cms
Proportion of patients who change their water in body composition Change between baseline and 6 months and between 6 months and 12 months water measured using bioelectronic impedancemetry
Proportion of patients with a change in quality of life Change between baseline and 6 months and between 6 months and 12 months EORTC QLQ-C30 questionnaire and its BR-23 module
Proportion of patients with a change in fatigue condition Change between baseline and 6 months and between 6 months and 12 months PFS-12 questionnaire
Proportion of patients who modify their professional status 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.
Number of patients who accept the connected device Baseline, 6 months and 12 months Self-administered qualitative questionnaire used in social psychology science
Trial Locations
- Locations (3)
CHRU Besançon
🇫🇷Besançon, France
Institut Sainte-Catherine
🇫🇷Avignon, France
Centre Léon Bérard
🇫🇷Lyon, France