University Rouen Hospital
Rouen, 76031, France
Location status: Recruiting
NCT Number: NCT07031830
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Rouen, 76031, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 4 months
Evaluation of a personalized hospital program consisting of 4 months of weekly collective sports activity sessions for the resumption of physical activity.
Time frame: 4 months
Evaluation of a personalized hospital program consisting of 4 months of regular in-person and phone motivational interviews for the resumption of physical activity.
Time frame: 24 months
Evaluation of the percentage of patients who accepted the sports module (hospital or club) among new patients treated for advanced melanoma during the inclusion period
Time frame: 12 months
Evaluation of - Percentage of patients having maintained physical activity at 12 months according to groups and reason for stopping
Time frame: 24 months
Evaluation of - Percentage of patients having maintained physical activity at 24 months according to groups and reason for stopping
Time frame: At enrollment visit and 6 months
Assessment of Percentage of improvement in the walking test at enrollment visit
Time frame: "Baseline"
Assessment of Percentage of improvement in the grip test at enrollment visit
Time frame: "Baseline"
Assessment of Percentage of improvement in the flexibility test at enrollment visit
Time frame: "Baseline"
Assessment of Percentage of improvement in the balance test at enrollment visit
Time frame: 6 months
Assessment of Percentage of improvement in the walking test between 0 and 6 months
Time frame: 6 months
Assessment of Percentage of improvement in the grip test, between 0 and 6 months
Time frame: 6 months
Assessment of Percentage of improvement in the flexibility test between 0 and 6 months
Time frame: 6 months
Assessment of Percentage of improvement in the balance test between 0 and 6 months
Time frame: "Baseline"
Evaluation of percentage of improvement in the QLQ C30 score At enrollment visit
Time frame: 6 months, 12 months and 24 months
Evaluation of percentage of improvement in the QLQ C30 score between 0 and 6 months
Time frame: At enrollment visit, 12 months
Evaluation of percentage of improvement in the QLQ C30 score 0-12 months
Time frame: At enrollment visit, 24 months
Evaluation of percentage of improvement in the QLQ C30 score between 0-24 months
Contact information is provided by the study sponsor or research team.
David DM MALLET, Director
CONTACT
02 32 88 82 65 ext. +33
Vincent VF FERRANTI, ARC
CONTACT
02 32 88 82 65 ext. +33
University Hospital, Rouen
Other
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
Acronym: APA-M
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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