APA (Adapted Physical Activity) for Patients With Advanced Melanoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Melanoma of Skin. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
APA (Adapted Physical Activity) for Patients With Advanced Melanoma APA (Adapted Physical Activity) for Patients With Advanced Melanoma Undergoing Treatment: Evaluation of a Personalized Program at the Hospital
Overview
APA (adapted physical activity) for patients with advanced melanoma APA (adapted physical activity) for patients with advanced melanoma undergoing treatment: evaluation of a personalized program at the hospital Melanoma is a malignant tumor developed from melanocytes. It accounts for approximately 4% of all incident cancers and 1.2% of cancer deaths, regardless of sex. Since 2011, the advent of new therapies (targeted therapies and immunotherapies) has revolutionized the management of advanced-stage melanoma (unresectable stage III or stage IV). These treatments have led to a significant improvement in the prognosis of metastatic melanoma, with a 5-year overall survival rate of 34% for targeted therapies, 44% for monotherapy with immunotherapy, and 52% for the combination of nivolumab + ipilimumab. Due to the improvement in survival rates, advanced melanoma has become a chronic disease affecting all ages. It is therefore essential to maintain the quality of life for these patients.
Detailed description
We know that melanoma and its treatments have an impact on the quality of life of patients: fatigue or impairment of muscular and cardiorespiratory capacities, for example.
Indeed, after a cancer diagnosis, the majority of patients reduce their physical activity. It is estimated that 50 to 75% of these patients do not meet the WHO recommendations (physically inactive). Five years after the cancer diagnosis, nearly half of the patients report limitations in their daily physical activities (walking, carrying, standing for extended periods, etc.).
This physical deconditioning can lead to an exercise intolerance state, resulting in decreased autonomy, quality of life, and self-esteem, along with increased physical and psychological symptoms, and fatigue.
In this context, the High Authority of Health (HAH) has issued several reports integrating physical activity into the care pathway of cancer patients. Indeed, numerous studies have shown the benefits of exercise, particularly in patients with breast or prostate cancer, in order to improve body composition, cardiorespiratory capacity, muscle strength, cancer-related fatigue, pain, anxiety, and quality of life, as well as to prevent treatment-related side effects. Some even mention an impact on survival in prostate cancer.
Currently, despite these reports and various publications illustrating the benefits of physical activity and its feasibility even in metastatic patients, there are many barriers to the prescription of adapted physical activity (APA) by healthcare professionals, who fear, for example, insufficient physical abilities for engaging in sports.
Moreover, to date, few adapted physical activity programs exist in France for patients with advanced melanoma being followed in dermatology. However, this is a population that is sometimes still young and active, requiring the prevention of physical deconditioning and its consequences.
Finally, patients with a history of advanced cancer are sometimes reluctant to resume an activity, Indeed, facing external club partners without health issues, in unfamiliar places, can be a barrier to resuming physical activity. Moreover, patients' motivation wanes over time despite the benefits gained.
Currently, no study has evaluated the interest of a hospital-based adapted physical activity (APA) program consisting of weekly sessions and/or regular in-person and phone motivational interviews for the resumption of physical activity and the maintenance of this activity over time.
Primary outcome measures
- Evaluation of a personalized hospital program [Time frame: 4 months]
- Evaluation of a personalized hospital program [Time frame: 4 months]
Secondary outcome measures (12)
- Evaluation of the adherence of patients with advanced melanoma to the physical activity project [Time frame: 24 months]
- Evaluation of the maintenance of physical activity over time [Time frame: 12 months]
- Evaluation of the maintenance of physical activity over time [Time frame: 24 months]
- Evaluation of the evolution of physical capacities in the short [Time frame: At enrollment visit and 6 months]
- Evaluation of the evolution of physical capacities in the short [Time frame: "Baseline"]
- Evaluation of the evolution of physical capacities in the short [Time frame: "Baseline"]
- Evaluation of the evolution of physical capacities in the short [Time frame: "Baseline"]
- Evaluation of the evolution of physical capacities in the long term [Time frame: 6 months]
- Evaluation of the evolution of physical capacities in the long term [Time frame: 6 months]
- Evaluation of the evolution of physical capacities in the long term [Time frame: 6 months]
- Evaluation of the evolution of physical capacities in the long term [Time frame: 6 months]
- Evaluation of the evolution of quality of life in the short term [Time frame: "Baseline"]
Eligibility criteria
Inclusion criteria
- Male or female patient aged 18 or older
- Advanced melanoma treated adjuvantly or curatively with immunotherapy or targeted therapy
- Patient who has read and understood the information letter and does not object to participating in the study
- Member of or beneficiary of a social security scheme
- Patients who have agreed to participate in the adapted sports module
Exclusion criteria
- Minor patient
- Melanoma not requiring systemic treatment
- Condition making 6-month follow-up impossible
- Protected incapacitated persons (judicial protection, guardianship, curatorship, deprivation of liberty)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- University Rouen Hospital — Rouen
Identifiers
NCT: NCT07031830 · 2024/0153/OB · N° IDRCB : 2024-A01567-40