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

NCT04536584 | Completed

• 3 other identifiers: eMOUVOIR-1902PHRC-K18-1612020-A00851-38
• Study Type: interventional
• Target: 824
• Locations: 1 country
• Sites: 22

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.

Conditions

Breast Cancer Female

Keywords

Non metastatic breast cancer; Post breast cancer support; Physical activities

Outcome Measures

Primary Outcomes (2)

• Quality of Life (QoL): SF 36 PCS

  This study will evaluate, in each randomized group, the difference between the baseline score and the 12-month score of summary score of this questionnaire: PCS (Physical Component Summary)

  1 year from the inclusion

• Quality of Life (QoL): SF 36 MCS

  This study will evaluate, in each randomized group, the difference between the baseline score and the 12-month score of summary score of this questionnaire: MCS (Mental Component Summary)

  1 year from the inclusion

Secondary Outcomes (14)

• Success/Failure score

  at 12 months after start of the program

• Health Related Quality of Life (HRQoL)

  at the baseline, 4 months, 8 months and 12 months.

• Practice of Exercise and Physical Activities (EPA)

  at the baseline, 4 months, 8 months and 12 months.

• Fatigue

  at the baseline, and 12 months.

• Pain level

  at the baseline, and 12 months.

Study Arms (2)

Arm A: personalized coaching for physical activities

EXPERIMENTAL

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

Other: Personalized Coaching (Arm A)

Arm B: standard supportive approach

ACTIVE COMPARATOR

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.

Other: Standard supportive approach (Arm B)

Interventions

Personalized Coaching (Arm A) 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 A: personalized coaching for physical activities

Standard supportive approach (Arm B) OTHER

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

Arm B: standard supportive approach

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient ≥18;
• Diagnosis of invasive non-metastatic breast cancer;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Oscar Lambret: lead
• Stimulab: collaborator

Study Sites (22)

Centre Léon Bérard

Lyon, Auvergne-Rhône-Alpes, 69379, France

Location

Groupe Hospitalier Bretagne Sud

Lorient, Brittany Region, 56100, France

Location

CARIO Hôpital Privé des Côtes d'Armor

Plérin, Brittany Region, 22190, France

Location

Centre Eugène marquis

Rennes, Brittany Region, 35042, France

Location

Centre d'oncologie et radiothérapie Saint-Jean

Saint-Doulchard, Centre-Val de Loire, 18230, France

Location

Sainte Catherine Institut du Cancer Avignon Provence

Avignon, France, 84918, France

Location

Centre Marie Curie

Arras, Hauts-de-France, 62000, France

Location

Centre Pierre Curie

Beuvry, Hauts-de-France, 62660, France

Location

CH de Boulogne-sur-Mer

Boulogne-sur-Mer, Hauts-de-France, 62321, France

Location

Centre de radiothérapie Amethyst

Compiègne, Hauts-de-France, 60200, France

Location

Institut André Dutreix

Dunkirk, Hauts-de-France, 59240, France

Location

Centre Oscar Lambret

Lille, Hauts-de-France, 59020, France

Location

Centre Gray-Amethyst Radiothérapie

Maubeuge, Hauts-de-France, 59600, France

Location

CH de Roubaix

Roubaix, Hauts-de-France, 59056, France

Location

Centre Joliot Curie

Saint-Martin-Boulogne, Hauts-de-France, 62280, France

Location

Centre de cancérologie Les Dentellières

Valenciennes, Hauts-de-France, 59300, France

Location

CH de Valenciennes

Valenciennes, Hauts-de-France, 59322, France

Location

Centre Hospitalier Eure-Seine - Hôpital d'Evreux

Évreux, Normandy, 27015, France

Location

Institut Bergonié

Bordeaux, Nouvelle-Aquitaine, 33076, France

Location

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, Nouvelle-Aquitaine, 33077, France

Location

Hôpital Privé du Confluent

Nantes, Pays de la Loire Region, 44277, France

Location

Institut Gustave Roussy

Villejuif, Île-de-France Region, 94800, France

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Laurence VANLEMMENS, MD

  Centre Oscar Lambret

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: September 2, 2020
• Study Start: December 18, 2020
• Primary Completion: June 26, 2024
• Study Completion: June 26, 2024
• Last Updated: March 18, 2026

Record last verified: 2025-09

Locations

FR (22)