Clinical trial NCT03518814: Quality of Life in Patients With Multimetastatic Melanoma Currently in Remission (QUALM)
Official title: Evaluation of the Quality of Life in Patients With Multimetastatic Melanoma Currently in Remission
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma (Skin) Stage IV
Remission
Keywords: Melanoma stage IV
Remission
Quality of life
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: University Hospital, Lille
First posted: 2018-05-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with multimetastatic melanoma currently in remission

Brief summary: 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.

Detailed description: The cutaneous melanoma, (9th rank of all cancers), was until recently neglected and poorly known by the general public. The metastatic stages have dramatic rates of survival: 25% at 1 year and 2% at 5 years with a median of about 6.2 months. However, in the last ten years, the treatment of metastatic forms has undergone a real revolution.

Its high metastatic potential for a very low initial tumor mass, gives evidence of a great aggressiveness. The cutaneous melanoma is resistant to the main therapeutics (chemotherapy and radiotherapy). Thanks to the emergence of immunotherapies and targeted therapies anti-RAF (Rapidly Accelerated Fibrosarcoma) and anti-MEK (Mitogen-activated Extracellular) the prognosis of patients with metastatic melanoma has considerably improved, increasing the number of "long-term survivors".

However, these treatments can cause many adverse effects that can impact patients' quality of life, despite a better tolerance compared to conventional chemotherapies. To our knowledge there are no data regarding the quality of life of patients with metastatic melanoma currently in remission.For this purpose, it is necessary to obtain solid data using validated questionnaires. Thus, we have chosen to evaluate quality of life using specific questionnaires to better understand patients' expectations, their difficulties, and then to improve the relationship between the patient and the physician.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life assessed by the Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaire
timeFrame: day 0
measure: Health status surveyed by the Medical Outcome Study Short Form - 36 (MOS SF 36) questionnaire
timeFrame: day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Lille Catholic Hospitals
state: Nord
city: Lille
country: France
facility: CHRU Lille
state: Nord
Study officials:
affiliation: Lille Catholic University
name: Aurore Le Guern
role: PRINCIPAL_INVESTIGATOR
References: