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NCT Number: NCT07031830

APA (Adapted Physical Activity) for Patients With Advanced Melanoma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Rouen Hospital

Rouen, 76031, France

Location status: Recruiting

Location contact

Claire CM MIGNARD, Doctor

CONTACT

[email protected]

02 32 88 53 84 ext. +33

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Evaluation of a personalized hospital program

    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.

  2. Evaluation of a personalized hospital program

    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.

Secondary outcomes

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

    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

  2. Evaluation of the maintenance of physical activity over time

    Time frame: 12 months

    Evaluation of - Percentage of patients having maintained physical activity at 12 months according to groups and reason for stopping

  3. Evaluation of the maintenance of physical activity over time

    Time frame: 24 months

    Evaluation of - Percentage of patients having maintained physical activity at 24 months according to groups and reason for stopping

  4. Evaluation of the evolution of physical capacities in the short

    Time frame: At enrollment visit and 6 months

    Assessment of Percentage of improvement in the walking test at enrollment visit

  5. Evaluation of the evolution of physical capacities in the short

    Time frame: "Baseline"

    Assessment of Percentage of improvement in the grip test at enrollment visit

  6. Evaluation of the evolution of physical capacities in the short

    Time frame: "Baseline"

    Assessment of Percentage of improvement in the flexibility test at enrollment visit

  7. Evaluation of the evolution of physical capacities in the short

    Time frame: "Baseline"

    Assessment of Percentage of improvement in the balance test at enrollment visit

  8. Evaluation of the evolution of physical capacities in the long term

    Time frame: 6 months

    Assessment of Percentage of improvement in the walking test between 0 and 6 months

  9. Evaluation of the evolution of physical capacities in the long term

    Time frame: 6 months

    Assessment of Percentage of improvement in the grip test, between 0 and 6 months

  10. Evaluation of the evolution of physical capacities in the long term

    Time frame: 6 months

    Assessment of Percentage of improvement in the flexibility test between 0 and 6 months

  11. Evaluation of the evolution of physical capacities in the long term

    Time frame: 6 months

    Assessment of Percentage of improvement in the balance test between 0 and 6 months

  12. Evaluation of the evolution of quality of life in the short term

    Time frame: "Baseline"

    Evaluation of percentage of improvement in the QLQ C30 score At enrollment visit

  13. Evaluation of the evolution of quality of life in the long term

    Time frame: 6 months, 12 months and 24 months

    Evaluation of percentage of improvement in the QLQ C30 score between 0 and 6 months

  14. Evaluation of the evolution of quality of life in the long term

    Time frame: At enrollment visit, 12 months

    Evaluation of percentage of improvement in the QLQ C30 score 0-12 months

  15. Evaluation of the evolution of quality of life in the long term

    Time frame: At enrollment visit, 24 months

    Evaluation of percentage of improvement in the QLQ C30 score between 0-24 months

Study contacts

Contact information is provided by the study sponsor or research team.

David DM MALLET, Director

CONTACT

[email protected]

02 32 88 82 65 ext. +33

Vincent VF FERRANTI, ARC

CONTACT

[email protected]

02 32 88 82 65 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study 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

Acronym: APA-M

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Jun 22, 2025
Registry last updated
Jun 22, 2025

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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