Impact of Personalized and Remote Support Centered on Exercise and Physical Activity for Breast Cancer Patients

NCT ID: NCT04536584

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 824 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-18
• Study Completion Date: 2024-06-26

Brief Summary

A study that evaluates the benefits of a personalized remote exercise and physical activity coaching compared with the standard supportive approach in terms of health-related quality of life at 12 months in breast cancer survivors treated in an adjuvant setting.

Detailed Description

A multicentric, phase III, randomized open-labelled study with two parallel groups which evaluates the benefits of a personalized remote exercise and physical activity coaching compared with the standard supportive approach in terms of health-related quality of life at 12 months in breast cancer survivors treated in an adjuvant setting.

Other objectives include:

• To evaluate the impact of the intervention on each dimension of the SF-36 at 12 months
• To evaluate the impact of the program on the health-related quality of life over time
• To evaluate the impact of the program on the practice of exercise and physical activity (EPA) at the recommended intensity (30min of moderate EPA, 5 days/week)
• To evaluate the impact of the program on:

o fatigue, pain, depression, sleep, motivation for the practice, self-respect, biometric measures (including fat mass and lean mass), physical capacities, patient's satisfaction regarding the assigned program, occurrence of Adverse Events (AE) related to the treatment, professional life for patients who worked before the announcement of getting cancer and psychotropic and analgesic drug intake

• To evaluate the compliance to the program through the engagement score during the first 4 months (in the experimental group).
• To evaluate the impact of the program in terms of disease-free survival

Additional objectives on health economics include:

• To evaluate the efficiency of the personalized remote exercise and physical activity coaching compared with the standard supportive approach in BC survivors treated in an adjuvant setting.
• To characterize the health-state utility of BC survivors over time; assessing the association of change in health-utility with changes in other variables such as exercise and physical activity.

Conditions

Breast Cancer Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm A: personalized coaching for physical activities

This arm consists of providing patients with a personalized coaching focused on exercise and physical activity, with or without connected watch.

Group Type: EXPERIMENTAL

Personalized Coaching (Arm A)

Intervention Type: OTHER

Patients will receive personalized physical activity coaching with an online digital platform to take online educational workshops and interact with other peers of the cohort with a online private forum. They will also have a connected watch that will measure several physical activity metrics.

Arm B: standard supportive approach

The standard supportive approach will consist in recommendations made during visits with the oncologist. The delivery of post-treatment care by oncologists and their team systematically provide exercise advice patients including recommendations for strength training and aerobic activity.

Group Type: ACTIVE_COMPARATOR

Standard supportive approach (Arm B)

Intervention Type: OTHER

Patients will receive the standard recommendations during their visits with the oncologist. The exercise recommendations include strength training and aerobic activities.

Interventions

Personalized Coaching (Arm A)

Patients will receive personalized physical activity coaching with an online digital platform to take online educational workshops and interact with other peers of the cohort with a online private forum. They will also have a connected watch that will measure several physical activity metrics.

Intervention Type: OTHER

Standard supportive approach (Arm B)

Patients will receive the standard recommendations during their visits with the oncologist. The exercise recommendations include strength training and aerobic activities.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient ≥18;
• Diagnosis of invasive non-metastatic breast cancer;
• 5 months (+/- 3 months) after the end of the treatment by surgery and/or radiotherapy and/or chemotherapy and/or other "short-term" systemic treatment : immunotherapy, PARP inhibitor, trastuzumab or TDM1 ; the continuation of hormonotherapy (more or less associated with an anti-CDK4/6), trastuzumab or TDM1 is possible during the study period;
• SF-36 filled in completely
• Medical certificate for sports practice delivered by a healthcare professional or oncologist. Neither the previous sports practice, nor the motivation for the proposed program is necessary to participate in the program.
• Agreement for follow-ups during the study period lasting 12 months;
• Ability to understand, read and write French;
• Patient covered by the French "Social Security" regime;
• Signed informed consent for the participation in the study, including the randomization with a 50%/50% chance of being allocated to one or the other group.

Exclusion Criteria

• Relapse of invasive breast cancer (loco-regional relapse, contralateral relapse)
• Inability to exercise because of a severe handicap or vulnerability. These contraindications are left to the discretion of the healthcare professional assessing capacity (ex : severe malnutrition, pregnancy …);
• Metastatic cancer;
• Expressed preference for one arm;
• Inability to comply with follow-up (4 and 12 months) of the trial (geographical, social, medical or psychological reasons);
• Person under guardianship or curatorship.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stimulab

UNKNOWN

Sponsor Role: collaborator

Centre Oscar Lambret

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurence VANLEMMENS, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Oscar Lambret

Locations

Centre Léon Bérard

Lyon, Auvergne-Rhône-Alpes, France

Groupe Hospitalier Bretagne Sud

Lorient, Brittany Region, France

CARIO Hôpital Privé des Côtes d'Armor

Plérin, Brittany Region, France

Centre Eugène marquis

Rennes, Brittany Region, France

Centre d'oncologie et radiothérapie Saint-Jean

Saint-Doulchard, Centre-Val de Loire, France

Sainte Catherine Institut du Cancer Avignon Provence

Avignon, France, France

Centre Marie Curie

Arras, Hauts-de-France, France

Centre Pierre Curie

Beuvry, Hauts-de-France, France

CH de Boulogne-sur-Mer

Boulogne-sur-Mer, Hauts-de-France, France

Centre de radiothérapie Amethyst

Compiègne, Hauts-de-France, France

Institut André Dutreix

Dunkirk, Hauts-de-France, France

Centre Oscar Lambret

Lille, Hauts-de-France, France

Centre Gray-Amethyst Radiothérapie

Maubeuge, Hauts-de-France, France

CH de Roubaix

Roubaix, Hauts-de-France, France

Centre Joliot Curie

Saint-Martin-Boulogne, Hauts-de-France, France

Centre de cancérologie Les Dentellières

Valenciennes, Hauts-de-France, France

CH de Valenciennes

Valenciennes, Hauts-de-France, France

Centre Hospitalier Eure-Seine - Hôpital d'Evreux

Évreux, Normandy, France

Institut Bergonié

Bordeaux, Nouvelle-Aquitaine, France

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, Nouvelle-Aquitaine, France

Hôpital Privé du Confluent

Nantes, Pays de la Loire Region, France

Institut Gustave Roussy

Villejuif, Île-de-France Region, France

Countries

France

Other Identifiers

eMOUVOIR-1901

Identifier Type: -

Identifier Source: org_study_id