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| Name | Class |
|---|---|
| University Hospital, Lille | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimetastatic melanoma in remission | Questionnaires |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Other | FACT-M (Functional Assessment of Cancer Therapy - Melanoma) questionnaire, MOS SF (medical outcome study short form) -36 questionnaire |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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:
| 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:
| day 0 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with multimetastatic melanoma currently in remission
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| Name | Affiliation | Role |
|---|---|---|
| Aurore Le Guern | Lille Catholic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lille Catholic Hospitals | Lille | Nord | 59020 | France | ||
| CHRU Lille |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Lille |
| Nord |
| 59037 |
| France |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |