Metastatic MelanomaNCT03326973
Long-Term Quality of Life in Patients With Metastatic Melanoma Treated With Checkpoint Inhibitors
An observational study of Metastatic Melanoma, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
Trial summary
To identify and describe long-term quality of life (QOL) issues in patients with metastatic melanoma treated with checkpoint inhibitors who achieved cancer control for a minimum of 12 months and remain on maintenance checkpoint inhibitor therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- EuroQoL EQ-5D-3L, EORTC QLQ-C30 and PRO-CTCAE
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 107 participants
- Where
- 6 sitesUnited States
- Study dates
- 25 Oct 2017to 14 Dec 2020
- 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: The melanoma service has agreed to provide this research team with access to a list of patients who are potentially eligible for this survey.
Who may be able to join
- Be able to speak and read English
- Be able to provide informed consent
- Have been diagnosed with metastatic melanoma at age 18 years or older
- Have been treated with either single agent or combination checkpoint inhibitor
- Be at least 12 months since first dose of above named agents
- Received no other systemic therapy after initiation of immunotherapy (interval radiation or surgery will be permitted based on review with primary treating medical oncologist)
Who cannot join
- Patients with cognitive, visual, or motor impairment such that they cannot complete the survey as assessed by the research or clinical team
- Patients who developed a subsequent cancer after starting on checkpoint inhibitor(s), exclusive of non-melanoma superficial skin cancers
- Patients with clinical documentation of progressive disease on the most recent assessment in the electronic medical record
- Patients with symptomatic progression but continue on immunotherapy
- Note: For any patients where the disease status is not clear, we will confirm that the disease is either stable or responsive with their primary treating medical oncologist
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Memoral Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memoral Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, 11570
About this study
To identify and describe long-term quality of life (QOL) issues in patients with metastatic melanoma treated with checkpoint inhibitors who achieved cancer control for a minimum of 12 months and remain on maintenance checkpoint inhibitor therapy.
- Conditions
- Metastatic Melanoma
- Being tested
- EuroQoL EQ-5D-3L, EORTC QLQ-C30, PRO-CTCAE, Fatigue severity score questionnaire, The COST
- Keywords
- Quality of Life (QoL), 17-518
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EuroQoL EQ-5D-3LBehavioural
Overall QOL
EORTC QLQ-C30Behavioural
General symptoms; physical, role, emotional, cognitive, and social functioning scales; fatigue, nausea/vomiting , and pain scales
PRO-CTCAEOther
Additional potential immune-specific symptoms
Fatigue severity score questionnaireBehavioural
Fatigue severity
The COSTBehavioural
Financial toxicity; satisfaction with ability to work
Physician informationBehavioural
Details on outside health providers
| Study group | Role | What they receive |
|---|---|---|
| online or telephone survey | This is a cross-sectional survey. Our main method of communication with patients will be email. Participants will complete a single online or telephone survey at a minimum of 12 months post initial treatment of checkpoint inhibitors and remain on maintenance therapy. Receives: Behavioral: EuroQoL EQ-5D-3L; Behavioral: EORTC QLQ-C30; Other: PRO-CTCAE; Behavioral: Fatigue severity score questionnaire; Behavioral: The COST; Behavioral: Physician information |
What is being measured
The primary outcome is the main question the study is designed to answer.
total score of Global QOL overall health index
On the EQ-5D-3L, respondents are asked to indicate their health state by marking the box associated with the most appropriate statement in each of the 5 dimensions, resulting in a one digit number expressing the level (1-3) selected for that dimension from no problems to extreme problems.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start25 Oct 2017
- Primary completion14 Dec 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah Korenstein, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326973
- Sponsor's protocol ID
- 17-518
- Status last verified
- Dec 2020
- First submitted
- 27 Oct 2017
- Last updated
- 17 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Quality of Life in Patients With Metastatic Melanoma Treated With Checkpoint Inhibitors
- ClinicalTrials.gov ID
- NCT03326973
- Acronym / sponsor ID
- 17-518
- Conditions
- Metastatic Melanoma
- Keywords
- Quality of Life (QoL), 17-518
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 31 Oct 2017 (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.
To identify and describe long-term quality of life (QOL) issues in patients with metastatic melanoma treated with checkpoint inhibitors who achieved cancer control for a minimum of 12 months and remain on maintenance checkpoint inhibitor therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| online or telephone survey | – | Behavioral: EuroQoL EQ-5D-3L, Behavioral: EORTC QLQ-C30, Other: PRO-CTCAE, Behavioral: Fatigue severity score questionnaire, Behavioral: The COST, Behavioral: Physician informationThis is a cross-sectional survey. Our main method of communication with patients will be email. Participants will complete a single online or telephone survey at a minimum of 12 months post initial treatment of checkpoint inhibitors and remain on maintenance therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The melanoma service has agreed to provide this research team with access to a list of patients who are potentially eligible for this survey.
Key inclusion criteria (6 listed)
- Be able to speak and read English
- Be able to provide informed consent
- Have been diagnosed with metastatic melanoma at age 18 years or older
- Have been treated with either single agent or combination checkpoint inhibitor
- Be at least 12 months since first dose of above named agents
Key exclusion criteria (5 listed)
- Patients with cognitive, visual, or motor impairment such that they cannot complete the survey as assessed by the research or clinical team
- Patients who developed a subsequent cancer after starting on checkpoint inhibitor(s), exclusive of non-melanoma superficial skin cancers
- Patients with clinical documentation of progressive disease on the most recent assessment in the electronic medical record
- Patients with symptomatic progression but continue on immunotherapy
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 |
|---|---|---|
| EuroQoL EQ-5D-3LOverall QOL | Behavioural | online or telephone survey |
| EORTC QLQ-C30General symptoms; physical, role, emotional, cognitive, and social functioning scales; fatigue, nausea/vomiting , and pain scales | Behavioural | online or telephone survey |
| PRO-CTCAEAdditional potential immune-specific symptoms | Other | online or telephone survey |
| Fatigue severity score questionnaireFatigue severity | Behavioural | online or telephone survey |
| The COSTFinancial toxicity; satisfaction with ability to work | Behavioural | online or telephone survey |
| Physician informationDetails on outside health providers | Behavioural | online or telephone survey |
Primary outcome
total score of Global QOL overall health index
Time frame: 1 year
On the EQ-5D-3L, respondents are asked to indicate their health state by marking the box associated with the most appropriate statement in each of the 5 dimensions, resulting in a one digit number expressing the level (1-3) selected for that dimension from no problems to extreme problems.
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 17 Dec 2020.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Deborah Korenstein, MD principal investigator
Memorial Sloan Kettering Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Melanoma, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
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 5 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 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
total score of Global QOL overall health index (time frame: 1 year). 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 17 Dec 2020.