APA (Adapted Physical Activity) for Patients With Advanced Melanoma

NCT07031830 | Recruiting

• 2 other identifiers: 2024/0153/OBN° IDRCB : 2024-A01567-40
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma of Skin

Keywords

adapted physical activity

Outcome Measures

Primary Outcomes (2)

• 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.

  4 months

• 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.

  4 months

Secondary Outcomes (15)

• Evaluation of the adherence of patients with advanced melanoma to the physical activity project

  24 months

• Evaluation of the maintenance of physical activity over time

  12 months

• Evaluation of the maintenance of physical activity over time

  24 months

• Evaluation of the evolution of physical capacities in the short

  At enrollment visit and 6 months

• Evaluation of the evolution of physical capacities in the short

  "Baseline"

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with advanced melanoma treated adjuvantly or curatively with immunotherapy or targeted therapy

You may qualify if:

• 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

You may not qualify if:

• Minor patient
• Melanoma not requiring systemic treatment
• Condition making 6-month follow-up impossible
• Protected incapacitated persons (judicial protection, guardianship, curatorship, deprivation of liberty)

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

University Rouen Hospital

Rouen, 76031, France

RECRUITING

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

David DM MALLET, Director

CONTACT

02 32 88 82 65; David.Mallet@chu-rouen.fr

Vincent VF FERRANTI, ARC

CONTACT

02 32 88 82 65; Vincent.Ferranti@chu-rouen.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 22, 2025
• Study Start: November 18, 2024
• Primary Completion (Estimated): November 18, 2028
• Study Completion (Estimated): January 2, 2029
• Last Updated: June 22, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)