Quality of Life in Patients With Multimetastatic Melanoma Currently in Remission (QUALM)

NCT03518814 | Completed

• 1 other identifier: RC-P0062
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Melanoma (Skin) Stage IV; Remission

Keywords

Melanoma stage IV; Remission; Quality of life

Outcome Measures

Primary Outcomes (2)

• Quality of life assessed by the Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaire

  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

  day 0

• Health status surveyed by the Medical Outcome Study Short Form - 36 (MOS SF 36) questionnaire

  The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. The eight sections are: * vitality * physical functioning * bodily pain * general health perceptions * physical role functioning * emotional role functioning * social role functioning * mental health

  day 0

Study Arms (1)

Multimetastatic melanoma in remission

Questionnaires

Other: Questionnaires

Interventions

Questionnaires OTHER

FACT-M (Functional Assessment of Cancer Therapy - Melanoma) questionnaire, MOS SF (medical outcome study short form) -36 questionnaire

Multimetastatic melanoma in remission

Eligibility Criteria

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

Study Population

Patients with multimetastatic melanoma currently in remission

You may qualify if:

• 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

You may not qualify if:

• Adjuvant treatment
• Patient under tutorship or curatorship
• Refusal to participate in the study

Sponsors & Collaborators

• Lille Catholic University: lead
• University Hospital, Lille: collaborator

Study Sites (2)

Lille Catholic Hospitals

Lille, Nord, 59020, France

Location

CHRU Lille

Lille, Nord, 59037, France

Location

MeSH Terms

Conditions

Melanoma

Interventions

Surveys and Questionnaires

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Aurore Le Guern

  Lille Catholic University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: May 8, 2018
• Study Start: April 9, 2018
• Primary Completion: June 5, 2018
• Study Completion: June 5, 2018
• Last Updated: July 19, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)