Clinical trial NCT04536584: Impact of Personalized and Remote Support Centered on Exercise and Physical Activity for Breast Cancer Patients
Official title: Randomized Study Estimating the Impact of a Personalized and Remote Support Centered on Exercise and Physical Activity for Patients After Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Keywords: Non metastatic breast cancer
Post breast cancer support
Physical activities
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: Stimulab
First posted: 2020-09-02
Enrollment: 824
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Quality of Life (QoL): SF 36 PCS
timeFrame: 1 year from the inclusion
measure: Quality of Life (QoL): SF 36 MCS
timeFrame: 1 year from the inclusion
Secondary outcomes:
measure: Success/Failure score
timeFrame: at 12 months after start of the program
measure: Health Related Quality of Life (HRQoL)
timeFrame: at the baseline, 4 months, 8 months and 12 months.
measure: Practice of Exercise and Physical Activities (EPA)
timeFrame: at the baseline, 4 months, 8 months and 12 months.
measure: Fatigue
timeFrame: at the baseline, and 12 months.
measure: Pain level
timeFrame: at the baseline, and 12 months.
measure: Depression
timeFrame: at the baseline, and 12 months.
measure: Sleep
timeFrame: at the baseline, and 12 months.
measure: Biometric measures (impedance)
timeFrame: at the baseline, 4 months, 8 months and 12 months.
measure: Physical capacities
timeFrame: at the baseline, 4 months, 8 months and 12 months.
measure: Adverse Events
timeFrame: at the baseline, 4 months, 8 months and 12 months.
measure: Professional activity status
timeFrame: at the baseline, 4 months, 8 months and 12 months.
measure: Drug intake
timeFrame: at the baseline, 4 months, 8 months and 12 months.
measure: Disease-free survival
timeFrame: at the baseline, 4 months, 8 months and 12 months.
measure: Health states descriptive system
timeFrame: at the baseline, 4 months, 8 months and 12 months.
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
state: Auvergne-Rhône-Alpes
city: Lorient
country: France
facility: Groupe Hospitalier Bretagne Sud
state: Bretagne
city: Plérin
country: France
facility: CARIO Hôpital Privé des Côtes d'Armor
state: Bretagne
city: Rennes
country: France
facility: Centre Eugène marquis
state: Bretagne
city: Saint-Doulchard
country: France
facility: Centre d'oncologie et radiothérapie Saint-Jean
state: Centre Val-de-Loire
city: Lille
country: France
facility: Centre Oscar Lambret
state: Hauts-de- France
city: Arras
country: France
facility: Centre Marie Curie
state: Hauts-de-France
city: Beuvry
country: France
facility: Centre Pierre Curie
state: Hauts-de-France
city: Boulogne-sur-Mer
country: France
facility: CH de Boulogne-sur-Mer
state: Hauts-de-France
city: Compiègne
country: France
facility: Centre de radiothérapie Amethyst
state: Hauts-de-France
city: Dunkerque
country: France
facility: Institut André Dutreix
state: Hauts-de-France
city: Maubeuge
country: France
facility: Centre Gray-Amethyst Radiothérapie
state: Hauts-de-France
city: Roubaix
country: France
facility: CH de Roubaix
state: Hauts-de-France
city: Saint-Martin-Boulogne
country: France
facility: Centre Joliot Curie
state: Hauts-de-France
city: Valenciennes
country: France
facility: Centre de cancérologie Les Dentellières
state: Hauts-de-France
city: Valenciennes
country: France
facility: CH de Valenciennes
state: Hauts-de-France
city: Évreux
country: France
facility: Centre Hospitalier Eure-Seine - Hôpital d'Evreux
state: Normandie
city: Bordeaux
country: France
facility: Institut Bergonié
state: Nouvelle-Aquitaine
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
state: Nouvelle-Aquitaine
city: Nantes
country: France
facility: Hôpital Privé du Confluent
state: Pays de la Loire
city: Avignon
country: France
facility: Sainte Catherine Institut du Cancer Avignon Provence
city: Villejuif
country: France
facility: Institut Gustave Roussy
state: Île-de-France
Study officials:
affiliation: Centre Oscar Lambret
name: Laurence VANLEMMENS, MD
role: PRINCIPAL_INVESTIGATOR
References: