Clinical trial · Observational
Quality of Life in Patients With Multimetastatic Melanoma Currently in Remission (QUALM)
Evaluation of the Quality of Life in Patients With Multimetastatic Melanoma Currently in Remission
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Few studies have been conducted on the quality of life of patients with stage IV melanoma. Particularly, there is no data regarding the quality of life of patients with a multimetastatic melanoma currently in remission. Then, the main objective of this study is to evaluate the quality of life from a point of view medico-psycho-social in patients with multimetastatic melanoma in remission for more than 6 months.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) Stage IV | Melanoma | PROBABILISTIC | 0.70 |
| Remission | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Multimetastatic melanoma in remission
- description
- Questionnaires
- interventionNames
- Other: Questionnaires
Primary outcomes (2)
- measure
- Quality of life assessed by the Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaire
- timeFrame
- day 0
- description
- The FACT-M questionnaire is a specific quality of life scale for patients treated for melanoma. It includes 51 items grouped into nine multi-item scores: six subscale scores and three summary scores. The six subscales consist of four subscales from the FACT-G: * physical well-being \[PWB\], score range: 0-28, higher values represent a worse outcome. * social well-being \[SWB\], score range: 0-28, higher values represent a better outcome. * emotional well-being \[EWB\], score range: 0-24, higher values represent a worse outcome. * functional well-being \[FWB\]), score range: 0-28, higher values represent a better outcome. One Melanoma scale, score range: 0-64, higher values represent a worse outcome. One Melanoma surgery scale, score range: 0-32, higher values represent a worse outcome. The three summary scores include: * the FACT-M Trial Outcome Index (TOI), score range: 0-120 * the FACT-G total score, score range: 0-108 * the FACT-M total score, score range: 0-172
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients * Presenting a stage IV melanoma of the American Joint Committee on Cancer (AJCC) classification (multimetastatic) in remission for more than 6 months: * Complete remission (defined as the complete disappearance of target lesions according to the RECIST criteria, based on a thoraco-abdomino-pelvic CT scan and a brain Magnetic resonance imaging (MRI) or * Complete metabolic remission (defined as the complete disappearance of target lesions in PET CT (positron emission tomography computed tomograph, that is to say, disappearance of the hypermetabolic character of the anatomic structures. There may remain target lesions in conventional CT but they are not hypermetabolic in PET CT) * Patients able to answer the questionnaires * Patients with enough understanding of the French language Exclusion Criteria: * Adjuvant treatment * Patient under tutorship or curatorship * Refusal to participate in the study
References
Publications (0)
Data not yet available