Breast Cancer
Conditions
Brief summary
The goal of this clinical trial is to evaluate the acceptability by patients treated for breast cancer of an adapted motor activity program over a period of 15 months controlled by a postural and functional analysis.. Participant population/health conditions: patients with newly operated breast cancer who are candidates for an adapted physical activity program
Detailed description
This is a prospective, longitudinal, single-center, open-label study of a population of newly operated breast cancer patients who were candidates for an adapted motor activity program. All included patients will be followed for a period of 15 months. Participating physicians will have the opportunity to recruit their patients during the 24 months following the study's initiation. The study will be completed once the last included patient has a final evaluation. The total duration of the study is 39 months (24 months of recruitment and 15 months of follow-up). Each patient will be assessed four times: at inclusion before initiation of cancer treatment, and at M3, M9 and M15. At each patient visit with the investigating physician, an assessment will be completed on the electronic CRF by the physician or by the site CRA under the responsibility of the investigating physician.
Interventions
OTHERAdapted motor activity
15-month adapted motor activity program based on a postural and functional analysis
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This is a prospective, longitudinal, single-center, open-label study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult woman, having given her consent to participate in the study, * Patient with non-metastatic breast cancer, * Cancer to be treated by surgery with or without adjuvant treatment (radiotherapy and/or chemotherapy).
Exclusion criteria
* Contraindication to the practice of a physical activity, * Mental deficiency or any other reason that could hinder the understanding or the strict application of the protocol, * Patient not affiliated to the French social security system, * Patient under legal protection, guardianship or curatorship, * Patient already included in another therapeutic study protocol aimed at evaluating the benefits of adapted physical activity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of compliance | Month 15 | Patients will be considered compliant if they have attended more than 50% of the physical adaptation program sessions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postural evaluation | Month 3 | The postural evaluation will be carried out using a force platform with strain gauges as sensors, allowing to measure the moment of the vertical force exerted on the plate, and to locate the center of pressure of the feet and to record the variations on the antero-posterior and lateral axes. The dual-tray platform used in the study allows separate assessment of the forces exerted under each of the lower limbs. |
| Pain assessment | Month 3 | Pain intensity will be assessed using a simple numerical scale (SNS) graduated from 0 (no pain) to 10 (worst pain imaginable). |
| Functional and mobility assessment of the shoulder | Month 3 | This evaluation will be carried out using the Constant questionnaire composed of 11 questions grouped into 4 items (pain, activities of daily living, mobility and power of the shoulder). A global score ranging from 0 to 100 is obtained (almost no function to normal function). |
| Assessment of the functional impact of the disease | Month 3 | The Primus is used to establish a score during the performance of a movement. The number and nature of the movements evaluated are independent from one patient to another, nevertheless 4 very precise movements will be carried out in all the patients included in this study: ironing, vacuuming, driving and the hand-grip. The tests performed on the same patient will be strictly identical from one examination to the next. A Primus score will be calculated for each gesture. A global score will be calculated for each patient. It corresponds to the total score obtained by the patient divided by the number of tests performed. For each test and for the global score, the score recorded at Day 0 will constitute the reference value. The evolution of the scores during the follow-up will be expressed as a percentage of variation in relation to this basal score. |
| Assessment of the impact of the disease on quality of life | Month 3 | Patients' quality of life will be assessed by completing the EORTC Core Quality of Life Questionnaire EORTC QLQ-C30 questionnaire with 30 questions |
| Assessment of sarcopenia | Month 15 | Sarcopenia will be measured by impedancemetry. The parameters collected will be in kilograms. |
| Assessment of the emotional impact of the disease | Month 3 | The emotional impact of the disease will be more precisely evaluated by the HAD questionnaire, a screening tool for the most common manifestations of anxiety and depressive disorders to be completed by the patient. The scale consists of 14 questions, with 7 items assessing anxiety and 7 items assessing depression. A minimum score of 10 on one of the sub-scores was retained as a screening criterion for depressive or anxious manifestations. |
Countries
France
Contacts
Primary ContactCyril FOA, MD
Backup ContactEmilie BIALECKI, PHD
Outcome results
None listed