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Trial record 3 of 12 for:    QUALMS

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03518814
Recruitment Status : Completed
First Posted : May 8, 2018
Last Update Posted : July 19, 2018
Sponsor:
Collaborator:
University Hospital, Lille
Information provided by (Responsible Party):
Lille Catholic University

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.


Condition or disease Intervention/treatment
Melanoma (Skin) Stage IV Remission Other: Questionnaires

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.

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Quality of Life in Patients With Multimetastatic Melanoma Currently in Remission
Actual Study Start Date : April 9, 2018
Actual Primary Completion Date : June 5, 2018
Actual Study Completion Date : June 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Group/Cohort Intervention/treatment
Multimetastatic melanoma in remission
Questionnaires
Other: Questionnaires
FACT-M (Functional Assessment of Cancer Therapy - Melanoma) questionnaire, MOS SF (medical outcome study short form) -36 questionnaire




Primary Outcome Measures :
  1. Quality of life assessed by the Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaire [ Time Frame: day 0 ]

    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

  2. Health status surveyed by the Medical Outcome Study Short Form - 36 (MOS SF 36) questionnaire [ Time Frame: day 0 ]

    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with multimetastatic melanoma currently in remission
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518814


Locations
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France
Lille Catholic Hospitals
Lille, Nord, France, 59020
CHRU Lille
Lille, Nord, France, 59037
Sponsors and Collaborators
Lille Catholic University
University Hospital, Lille
Investigators
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Principal Investigator: Aurore Le Guern Lille Catholic University
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Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT03518814    
Other Study ID Numbers: RC-P0062
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lille Catholic University:
Melanoma stage IV
Remission
Quality of life
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas