Breast Neoplasms
Conditions
Keywords
Breast, Neoplams, adapted physical activity
Brief summary
Literature have shown the benefit of practicing regular physical activity during and after cancer treatment, particularly in terms of improving quality of life. The French Fencing Federation has thus developed an adapted physical activity program (Solution RIPOSTE) specially intended for patients with breast cancer. Adapted fencing sessions (saber) are thus offered to these patients in a perfectly secure context (i.e. compulsory medical-sports evaluation and trained fencing master). Since 2016, this RIPOSTE program has been implemented in several fencing halls in Lorraine. Our research project (controlled, randomized trial) aims to assess the impact of the practice of adapted fencing on the quality of life of patients, the functional capacities of the operated side (shoulder) and on the reduction of the sides effects of treatments. Our hypothesis is that such an adapted fencing program improves quality of life as well as functional abilities.
Interventions
OTHERAdapted Physical Activity
Intervention consists in 1h30/week of adapted fencing
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be a woman * ≥ 18 years old. * Have undergone unilateral breast surgery for primary invasive breast cancer * Time between surgery and inclusion between 2 to 4 weeks after surgery * Accept and be able to complete self-administered questionnaires * Satisfy the prior medico-sports evaluation * Be affiliated to a social security scheme or beneficiary of such a scheme * Have received full information on the organization of the research and have signed their informed consent.
Exclusion criteria
* Presence of bone metastases, especially vertebral * Presence of a contraindication to the practice of fencing during the medico-sports evaluation (post-surgery period that is too painful and / or requiring specific treatment in rehabilitation) * Refusal to participate in the study * Woman of childbearing age who does not have effective contraception. * Persons referred to Articles L.1121-5, L.1121-7 and L. 1121-8 of the Public Health Code * Pregnant woman, parturient or nursing mother * Minor (non-emancipated) * Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice) * Person of full age unable to express consent * Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline score of Quality of Life Questionnaire Core 30 (QLQ-C30) at 3 months. | Baseline (J0) and at 3 months (M3) | Questionnaire. 30 items. minimum value = 30. Maximum value = 120. A high score means a worse outcome (i.e. poor quality of life) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline score of Disabilities of the Arm, Shoulder and Hand measurement tool (DASH) at 3 months | Baseline (J0) and at 3 months (M3) | Questionnaire. 30 items. The score ranges from 0 (no disability) to 100 (most severe disability). |
| Change from baseline score of Multidimensional Fatigue Inventory (MFI-20) at 3 months | Baseline (J0) and at 3 months (M3) | Questionnaire. 20 items. Minimal value = 20. Maximal value = 100. A high score means a worse outcome (i.e. high level of fatigue) |
| Change from baseline score of Hospital Anxiety and Depression Scale at 3 months. | Baseline (J0) and at 3 months (M3) | Questionnaire. 14 items. The score ranges from 0 to 100. a high score means a worse outcome (i.e. high level of anxiety and depression) |
Countries
France
Contacts
Primary ContactMathias POUSSEL, MD, PhD
Outcome results
None listed