Melanoma (Skin) Stage IVQUALMNCT03518814
Quality of Life in Patients With Multimetastatic Melanoma Currently in Remission (QUALM)
An observational study of Melanoma (Skin) Stage IV and Remission, run by Lille Catholic University at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin) Stage IV, Remission
- What is being tested?
- Questionnaires
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- 9 Apr 2018to 5 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with multimetastatic melanoma currently in remission
Who may be able to join
- 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
Who cannot join
- Adjuvant treatment
- Patient under tutorship or curatorship
- Refusal to participate in the study
Trial locations and contacts
2 sites in 1 country.
France2 sites
Lille Catholic Hospitals
Lille, Nord, 59020
CHRU Lille
Lille, Nord, 59037
About this study
Official title: Evaluation of the Quality of Life in Patients With Multimetastatic Melanoma Currently in Remission
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.
Read the 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.
- Conditions
- Melanoma (Skin) Stage IV, Remission
- Being tested
- Questionnaires
- Keywords
- Melanoma stage IV, Remission, Quality of life
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
FACT-M (Functional Assessment of Cancer Therapy - Melanoma) questionnaire, MOS SF (medical outcome study short form) -36 questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Multimetastatic melanoma in remission | Questionnaires Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start9 Apr 2018
- Primary completion5 Jun 2018
- Study completion5 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin) Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille
- Responsible party
- Sponsor
- Investigators
- Aurore Le Guern, Principal investigator, Lille Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518814
- Sponsor's protocol ID
- RC-P0062
- Acronym
- QUALM
- Status last verified
- Jul 2018
- First submitted
- 25 Apr 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Quality of Life in Patients With Multimetastatic Melanoma Currently in Remission
- ClinicalTrials.gov ID
- NCT03518814
- Acronym / sponsor ID
- QUALM / RC-P0062
- Conditions
- Melanoma (Skin) Stage IV, Remission
- Keywords
- Melanoma stage IV, Remission, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- University Hospital, Lille
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 5 Jun 2018 (actual)
- Study completion
- 5 Jun 2018 (actual)
- First posted
- 8 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimetastatic melanoma in remission | – | Other: QuestionnairesQuestionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with multimetastatic melanoma currently in remission
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Adjuvant treatment
- Patient under tutorship or curatorship
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesFACT-M (Functional Assessment of Cancer Therapy - Melanoma) questionnaire, MOS SF (medical outcome study short form) -36 questionnaire | Other | Multimetastatic melanoma in remission |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Melanoma (Skin) Stage IV
RecruitingPhase 3
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
Melanoma
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 4
Dabrafenib and/or Trametinib Rollover Study
Melanoma, Non Small Cell Lung Cancer
RecruitingPhase 2
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurore Le Guern principal investigator
Lille Catholic University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma (Skin) Stage IV and Remission, run by Lille Catholic University at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life assessed by the Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaire (time frame: day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.