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| Name | Class |
|---|---|
| Fondation ARC | OTHER |
| National Cancer Institute, France | OTHER_GOV |
| Fondation pour la Recherche Médicale | OTHER |
| Cancéropôle Lyon Auvergne Rhône-Alpes |
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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.
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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Connected device | Experimental | 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 | Experimental | 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. |
|
| Combined | Experimental | Women will benefit from both the "connected device" intervention and the "therapeutic education" intervention and receive international recommendations on physical activity. |
|
| Control | No Intervention | Women will receive standard care, i.e., international recommendations on physical activity, without further intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Connected device | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-utility of the interventions as assessed using clinical data (treatments received, patients' diary on medical consultations) and hospital costs (national data). | The cost-utility of implementing each intervention will be assessed. | 12 months |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Béatrice Fervers, MD, PhD | Centre Léon Bérard, Lyon, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Sainte-Catherine | Avignon | France | ||||
| CHRU Besançon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21935600 | Background | Beasley JM, Kwan ML, Chen WY, Weltzien EK, Kroenke CH, Lu W, Nechuta SJ, Cadmus-Bertram L, Patterson RE, Sternfeld B, Shu XO, Pierce JP, Caan BJ. Meeting the physical activity guidelines and survival after breast cancer: findings from the after breast cancer pooling project. Breast Cancer Res Treat. 2012 Jan;131(2):637-43. doi: 10.1007/s10549-011-1770-1. Epub 2011 Sep 21. | |
| 28387544 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| D057185 | Sedentary Behavior |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| OTHER |
| AG2R La Mondiale | OTHER |
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.
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|
| Therapeutic education | Behavioral | 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:
|
|
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) |
The cost-effectiveness of implementing each intervention will be assessed. |
| 12 months |
| Assessment of the association between the objective and subjective characteristics of living spaces and patients' PA practices. | ALPHA questionnaire | 12 months |
| Besançon |
| France |
| Centre Léon Bérard | Lyon | 69008 | France |
| Background |
| Beg MS, Gupta A, Stewart T, Rethorst CD. Promise of Wearable Physical Activity Monitors in Oncology Practice. J Oncol Pract. 2017 Feb;13(2):82-89. doi: 10.1200/JOP.2016.016857. |
| 26071863 | Background | Cadmus-Bertram LA, Marcus BH, Patterson RE, Parker BA, Morey BL. Randomized Trial of a Fitbit-Based Physical Activity Intervention for Women. Am J Prev Med. 2015 Sep;49(3):414-8. doi: 10.1016/j.amepre.2015.01.020. Epub 2015 Jun 10. |
| 25890168 | Background | Ferguson T, Rowlands AV, Olds T, Maher C. The validity of consumer-level, activity monitors in healthy adults worn in free-living conditions: a cross-sectional study. Int J Behav Nutr Phys Act. 2015 Mar 27;12:42. doi: 10.1186/s12966-015-0201-9. |
| 25220842 | Background | Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9. |
| 20411366 | Background | Ibrahim EM, Al-Homaidh A. Physical activity and survival after breast cancer diagnosis: meta-analysis of published studies. Med Oncol. 2011 Sep;28(3):753-65. doi: 10.1007/s12032-010-9536-x. Epub 2010 Apr 22. |
| 25752971 | Background | Lahart IM, Metsios GS, Nevill AM, Carmichael AR. Physical activity, risk of death and recurrence in breast cancer survivors: A systematic review and meta-analysis of epidemiological studies. Acta Oncol. 2015 May;54(5):635-54. doi: 10.3109/0284186X.2014.998275. Epub 2015 Mar 9. |
| 28123997 | Background | Sullivan AN, Lachman ME. Behavior Change with Fitness Technology in Sedentary Adults: A Review of the Evidence for Increasing Physical Activity. Front Public Health. 2017 Jan 11;4:289. doi: 10.3389/fpubh.2016.00289. eCollection 2016. |
| 27286758 | Background | Thariat J, Creisson A, Chamignon B, Dejode M, Gastineau M, Hebert C, Boissin F, Topfer C, Gilbert E, Grondin B, Guennoc H, Mari V, Buzzo S, Saja D, Duboue N, Boulahssass R, Tosi A, Verne S, Ducray J, Benard-Thiery I, Ferrero JM. [Integrating patient education in your oncology practice]. Bull Cancer. 2016 Jul-Aug;103(7-8):674-90. doi: 10.1016/j.bulcan.2016.04.007. Epub 2016 Jun 7. French. |
| 18562971 | Background | Tudor-Locke C, Hatano Y, Pangrazi RP, Kang M. Revisiting "how many steps are enough?". Med Sci Sports Exerc. 2008 Jul;40(7 Suppl):S537-43. doi: 10.1249/MSS.0b013e31817c7133. |
| 34518245 | Derived | Touillaud M, Fournier B, Perol O, Delrieu L, Maire A, Belladame E, Perol D, Perrier L, Preau M, Leroy T, Fassier JB, Fillol F, Pascal S, Durand T, Fervers B. Connected device and therapeutic patient education to promote physical activity among women with localised breast cancer (DISCO trial): protocol for a multicentre 2x2 factorial randomised controlled trial. BMJ Open. 2021 Sep 13;11(9):e045448. doi: 10.1136/bmjopen-2020-045448. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |