Melanoma of SkinAPA-MNCT07031830
APA (Adapted Physical Activity) for Patients With Advanced Melanoma
An observational study of Melanoma of Skin, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma of Skin
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 18 Nov 2024to 2 Jan 2029
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with advanced melanoma treated adjuvantly or curatively with immunotherapy or targeted therapy
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Rouen Hospital
Rouen, 76031
Claire CM MIGNARD, Doctor, 02 32 88 53 84 ext. +33, Claire.Mignard@chu-rouen.fr
About this study
Official 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
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).
Read more
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.
Read the detailed description
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.
- Conditions
- Melanoma of Skin
- Keywords
- adapted physical activity
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 months
Secondary outcomes (15)
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
Measured: 24 months
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
Measured: 12 months
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
Measured: 24 months
Evaluation of the evolution of physical capacities in the short
Assessment of Percentage of improvement in the walking test at enrollment visit
Measured: At enrollment visit and 6 months
Evaluation of the evolution of physical capacities in the short
Assessment of Percentage of improvement in the grip test at enrollment visit
Measured: "Baseline"
Evaluation of the evolution of physical capacities in the short
Assessment of Percentage of improvement in the flexibility test at enrollment visit
Measured: "Baseline"
Evaluation of the evolution of physical capacities in the short
Assessment of Percentage of improvement in the balance test at enrollment visit
Measured: "Baseline"
Evaluation of the evolution of physical capacities in the long term
Assessment of Percentage of improvement in the walking test between 0 and 6 months
Measured: 6 months
Evaluation of the evolution of physical capacities in the long term
Assessment of Percentage of improvement in the grip test, between 0 and 6 months
Measured: 6 months
Evaluation of the evolution of physical capacities in the long term
Assessment of Percentage of improvement in the flexibility test between 0 and 6 months
Measured: 6 months
Evaluation of the evolution of physical capacities in the long term
Assessment of Percentage of improvement in the balance test between 0 and 6 months
Measured: 6 months
Evaluation of the evolution of quality of life in the short term
Evaluation of percentage of improvement in the QLQ C30 score At enrollment visit
Measured: "Baseline"
Evaluation of the evolution of quality of life in the long term
Evaluation of percentage of improvement in the QLQ C30 score between 0 and 6 months
Measured: 6 months, 12 months and 24 months
Evaluation of the evolution of quality of life in the long term
Evaluation of percentage of improvement in the QLQ C30 score 0-12 months
Measured: At enrollment visit, 12 months
Evaluation of the evolution of quality of life in the long term
Evaluation of percentage of improvement in the QLQ C30 score between 0-24 months
Measured: At enrollment visit, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start18 Nov 2024
- Primary completion18 Nov 2028 (estimated)
- Study completion2 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma of SkinStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031830
- Sponsor's protocol ID
- 2024/0153/OB
- Other IDs
- N° IDRCB : 2024-A01567-40
- Acronym
- APA-M
- Status last verified
- Dec 2024
- First submitted
- 4 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07031830
- Acronym / sponsor ID
- APA-M / 2024/0153/OB
- Conditions
- Melanoma of Skin
- Keywords
- adapted physical activity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 18 Nov 2028 (estimated)
- Study completion
- 2 Jan 2029 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with advanced melanoma treated adjuvantly or curatively with immunotherapy or targeted therapy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Minor patient
- Melanoma not requiring systemic treatment
- Condition making 6-month follow-up impossible
- Protected incapacitated persons (judicial protection, guardianship, curatorship, deprivation of liberty)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
15 secondary outcomes
Evaluation of the adherence of patients with advanced melanoma to the physical activity project
Time frame: 24 months
Evaluation of the maintenance of physical activity over time
Time frame: 12 months
Evaluation of the maintenance of physical activity over time
Time frame: 24 months
Evaluation of the evolution of physical capacities in the short
Time frame: At enrollment visit and 6 months
Evaluation of the evolution of physical capacities in the short
Time frame: "Baseline"
Evaluation of the evolution of physical capacities in the short
Time frame: "Baseline"
Evaluation of the evolution of physical capacities in the short
Time frame: "Baseline"
Evaluation of the evolution of physical capacities in the long term
Time frame: 6 months
Evaluation of the evolution of physical capacities in the long term
Time frame: 6 months
Evaluation of the evolution of physical capacities in the long term
Time frame: 6 months
Evaluation of the evolution of physical capacities in the long term
Time frame: 6 months
Evaluation of the evolution of quality of life in the short term
Time frame: "Baseline"
Evaluation of the evolution of quality of life in the long term
Time frame: 6 months, 12 months and 24 months
Evaluation of the evolution of quality of life in the long term
Time frame: At enrollment visit, 12 months
Evaluation of the evolution of quality of life in the long term
Time frame: At enrollment visit, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma of Skin, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David DM MALLET, Director (02 32 88 82 65 ext. +33, David.Mallet@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of a personalized hospital program (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.