Breast CancerDISCONCT03529383
Efficacy of Exercise Using Connected Activity Trackers and Therapeutic Education in Localized Breast Cancer
A study testing Connected device and Therapeutic education in people with Breast Cancer, run by Centre Leon Berard at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Connected device and Therapeutic education
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 436 participants
- Where
- 3 sitesFrance
- Study dates
- 18 May 2018to 23 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Institut Sainte-Catherine
Avignon
CHRU Besançon
Besançon
Centre Léon Bérard
Lyon, 69008
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Connected device, Therapeutic education
- Keywords
- Localized breast cancer, Exercise, Adapted physical activity, Sedentary, Connected device, Activity trackers, Therapeutic education, Obesity
- Medical subject headings
- Breast Neoplasms, Motor Activity, Sedentary Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connected deviceDevice
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.
Therapeutic educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Connected device |
| 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. Receives: Behavioral: Therapeutic education |
| Combined | Experimental | Women will benefit from both the "connected device" intervention and the "therapeutic education" intervention and receive international recommendations on physical activity. Receives: Device: Connected device; Behavioral: Therapeutic education |
| Control | No intervention | Women will receive standard care, i.e., international recommendations on physical activity, without further intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (28)
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
Measured: 12 months
Proportion of patients who are compliant to the programs
Participation rate in planned sessions
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their weight
Weight in kilograms
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their tobacco use
Self-administered questionnaire
Measured: Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their alcohol intake
Self-administered questionnaire
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Change between Day 0 and 6 months
Proportion of patients with a modification on vitamin D status
Blood sample
Measured: Change between Day 0 and 6 months
Number of patients who accept the connected device
Self-administered qualitative questionnaire used in social psychology science
Measured: Baseline, 6 months and 12 months
Number of patients who accept the therapeutic program
self-administered qualitative questionnaire used in social psychology science
Measured: Baseline, 6 months and 12 months
Proportion of patients who refuse to participate
Refusal rate among eligible patients to whom the study was presented
Measured: Baseline (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start18 May 2018
- Primary completion4 Mar 2022
- Study completion23 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- 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)
- Enrolment
- 436 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation ARC, National Cancer Institute, France, Fondation pour la Recherche Médicale, Cancéropôle Lyon Auvergne Rhône-Alpes, AG2R La Mondiale
- Responsible party
- Sponsor
- Investigators
- Béatrice Fervers, MD, PhD, Principal investigator, Centre Léon Bérard, Lyon, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529383
- Sponsor's protocol ID
- ET17-203 DISCO
- Acronym
- DISCO
- Status last verified
- Jul 2022
- First submitted
- 13 Apr 2018
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21935600Beg 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.
PubMed 28387544Cadmus-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.
PubMed 26071863Ferguson 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.
PubMed 25890168Ferlay 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.
PubMed 25220842Ibrahim 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.
PubMed 20411366Lahart 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.
PubMed 25752971Sullivan 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.
PubMed 28123997Thariat 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.
PubMed 27286758Tudor-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.
PubMed 18562971Touillaud 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.
PubMed 34518245
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03529383
- Acronym / sponsor ID
- DISCO / ET17-203 DISCO
- Conditions
- Breast Cancer
- Keywords
- Localized breast cancer, Exercise, Adapted physical activity, Sedentary, Connected device, Activity trackers, Therapeutic education, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 436 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- Fondation ARC, National Cancer Institute, France, Fondation pour la Recherche Médicale, Cancéropôle Lyon Auvergne Rhône-Alpes, AG2R La Mondiale
- Study start
- 18 May 2018 (actual)
- Primary completion
- 4 Mar 2022 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 18 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Connected device | Experimental | Device: Connected deviceWomen 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 | Behavioral: Therapeutic educationWomen 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 | Device: Connected device, Behavioral: Therapeutic educationWomen 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Connected deviceWomen 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. | Device | Combined, Connected device |
| Therapeutic educationWomen 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. | Behavioural | Combined, Therapeutic education |
Primary outcome
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)
Time frame: 6 months
Assessed by the RPAQ self-administered questionnaire
28 secondary outcomes
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)
Time frame: 12 months
Proportion of patients who are compliant to the programs
Time frame: 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 frame: 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)
Time frame: 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)
Time frame: Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their physical condition (Hand-grip test)
Time frame: 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)
Time frame: Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their physical condition
Time frame: Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their weight
Time frame: Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their waist circumference
Time frame: Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their hip circumference
Time frame: Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their BMI
Time frame: Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their fat mass in body composition
Time frame: 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
Time frame: 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
Time frame: Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their water in body composition
Time frame: Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their tobacco use
Time frame: Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who change their alcohol intake
Time frame: Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients with a change in quality of life
Time frame: Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients with a change in fatigue condition
Time frame: 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
Time frame: Change between baseline and 6 months and between 6 months and 12 months
Proportion of patients who modify their professional status
Time frame: 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)
Time frame: 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)
Time frame: Change between Day 0 and 6 months
Proportion of patients with a modification on vitamin D status
Time frame: Change between Day 0 and 6 months
Number of patients who accept the connected device
Time frame: Baseline, 6 months and 12 months
Number of patients who accept the therapeutic program
Time frame: Baseline, 6 months and 12 months
Proportion of patients who refuse to participate
Time frame: Baseline (day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Background: PubMed 21935600Beasley 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.
- Background: PubMed 28387544Beg 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.
- Background: PubMed 26071863Cadmus-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.
- Background: PubMed 25890168Ferguson 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.
- Background: PubMed 25220842Ferlay 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.
- Background: PubMed 20411366Ibrahim 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.
- Background: PubMed 25752971Lahart 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.
- Background: PubMed 28123997Sullivan 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.
- Background: PubMed 27286758Thariat 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.
- Background: PubMed 18562971Tudor-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.
- Derived from this study: PubMed 34518245Touillaud 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Béatrice Fervers, MD, PhD principal investigator
Centre Léon Bérard, Lyon, France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connected device and Therapeutic education in people with Breast Cancer, run by Centre Leon Berard at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03529383, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.