APA (Adapted Physical Activity) for Patients With Advanced Melanoma

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APA (Adapted Physical Activity) for Patients With Advanced Melanoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07031830
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Hospital, Rouen
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma of Skin

Additional Details

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.

Arms & Interventions

Arms

: Evaluation of a personalized program at the hospital through adapted physical activity

Evaluation of a personalized hospital program consisting of 4 months of weekly group sports activity sessions and/or regular in-person and phone motivational interviews for the resumption of physical activity.

Interventions

Contact a Trial Team

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