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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Connected device
* Behavioral: Therapeutic education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Connected device<br>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<br>* 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.<br>|
| Experimental: Therapeutic education<br>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<br>* 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.<br>|
| Experimental: Combined<br>Women will benefit from both the connected device intervention and the therapeutic education intervention and receive international recommendations on physical activity. | Device: Connected device<br>* 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.<br>Behavioral: Therapeutic education<br>* 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.<br>|
| No Intervention: Control<br>Women will receive standard care, i.e., international recommendations on physical activity, without further intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 
| Proportion of patients who are compliant to the programs | Participation rate in planned sessions | 6 months | 
| Proportion of patients who change their physical activity profile (Time spent in different intensities of physical activity, time spent in sedentary activities) | 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) | 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) | Sit to stand test | Change between baseline and 6 months and between 6 months and 12 months | 
| Proportion of patients who change their physical condition (Hand-grip test) | Hand-grip test | Change between baseline and 6 months and between 6 months and 12 months | 
| Proportion of patients who change their physical condition (sit-and-reach flexibility test) | sit-and-reach flexibility test | Change between baseline and 6 months and between 6 months and 12 months | 
| Proportion of patients who change their physical condition | single-leg balance test | Change between baseline and 6 months and between 6 months and 12 months | 
| Proportion of patients who change their weight | Weight in kilograms | Change between baseline and 6 months and between 6 months and 12 months | 
| Proportion of patients who change their waist circumference | Waist circumference in cms | Change between baseline and 6 months and between 6 months and 12 months | 
| Proportion of patients who change their hip circumference | Hip circumference in cms | Change between baseline and 6 months and between 6 months and 12 months | 
| Proportion of patients who change their BMI | weight in kilograms and height in meters will be combined to report BMI in kg/m^2 | Change between baseline and 6 months and between 6 months and 12 months | 
| Proportion of patients who change their fat mass in body composition | fat mass measured using bioelectronic impedancemetry | Change between baseline and 6 months and between 6 months and 12 months | 
| Proportion of patients who change their lean body mass in body composition | lean body mass measured using bioelectronic impedancemetry | Change between baseline and 6 months and between 6 months and 12 months | 
| Proportion of patients who change their fat free mass in body composition | fat free mass measured using bioelectronic impedancemetry | Change between baseline and 6 months and between 6 months and 12 months | 
| Proportion of patients who change their water in body composition | water measured using bioelectronic impedancemetry | Change between baseline and 6 months and between 6 months and 12 months | 
| Proportion of patients who change their tobacco use | Self-administered questionnaire | Change between baseline and 6 months and between 6 months and 12 months | 
| Proportion of patients who change their alcohol intake | Self-administered questionnaire | Change between baseline and 6 months and between 6 months and 12 months | 
| Proportion of patients with a change in quality of life | EORTC QLQ-C30 questionnaire and its BR-23 module | Change between baseline and 6 months and between 6 months and 12 months | 
| Proportion of patients with a change in fatigue condition | PFS-12 questionnaire | Change between baseline and 6 months and between 6 months and 12 months | 
| Proportion of patients with a change in health-related quality of life | EQ-5D-5L questionnaire | Change between baseline and 6 months and between 6 months and 12 months | 
| Proportion of patients who modify their professional status | Change in professional status, return to work, and perceived difficulty at work by a self-administered questionnaire. | Change between baseline and 6 months and between 6 months and 12 months | 
| Proportion of patients with a modification on serum circulating levels of endocrine factors (insulin, IGF1, estradiol) | Blood sample | Change between Day 0 and 6 months | 
| Proportion of patients with a modification on plasma circulating levels of cytokines (inflammatory cytokines: IL-6, TNF, and CRP; adipokines: adiponectin and leptin) | Blood sample | Change between Day 0 and 6 months | 
| Proportion of patients with a modification on vitamin D status | Blood sample | Change between Day 0 and 6 months | 
| Number of patients who accept the connected device | Self-administered qualitative questionnaire used in social psychology science | Baseline, 6 months and 12 months | 
| Number of patients who accept the therapeutic program | self-administered qualitative questionnaire used in social psychology science | Baseline, 6 months and 12 months | 
| Proportion of patients who refuse to participate | Refusal rate among eligible patients to whom the study was presented | Baseline (day 0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Localized breast cancer, Exercise, Adapted physical activity, Sedentary, Connected device, Activity trackers, Therapeutic education, Obesity