APA (Adapted Physical Activity) for Patients With Advanced Melanoma
ConditionMelanoma of Skin
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Rouen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 population
Patient with advanced melanoma treated adjuvantly or curatively with immunotherapy or targeted therapy
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 1 trial groupGroup A: Evaluation of a personalized program at the hospital through adapted physical activity
Trial outcomes
Primary outcomes
1
Evaluation of a personalized hospital program
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 months2
Evaluation of a personalized hospital program
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
4 monthsSecondary outcomes
1
Evaluation of the adherence of patients with advanced melanoma to the physical activity project
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
24 months2
Evaluation of the maintenance of physical activity over time
Evaluation of - Percentage of patients having maintained physical activity at 12 months according to groups and reason for stopping
Time frame
12 months3
Evaluation of the maintenance of physical activity over time
Evaluation of - Percentage of patients having maintained physical activity at 24 months according to groups and reason for stopping
Time frame
24 months4
Evaluation of the evolution of physical capacities in the short
Assessment of Percentage of improvement in the walking test at enrollment visit
Time frame
At enrollment visit and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov