- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05115006
A Study of Adjuvant Melanoma Stakeholder Treatment Preferences
June 29, 2022 updated by: Bristol-Myers Squibb
Adjuvant Melanoma Stakeholder Treatment Preference Study
The purpose of this study is to understand the trade-offs that participants with surgically treated melanoma would be willing to make among key features and outcomes of adjuvant anti-cancer treatments or no adjuvant treatment / observation.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
294
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Victoria
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Melbourne, Victoria, Australia, 3084
- Local Institution
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
This study is to include 350 adult participants from the US, Australia, UK, Germany, France, Spain, and Italy who self-report to have stage IIb, IIc, or III melanoma and who have had surgery for melanoma within 12 months.
Description
Inclusion Criteria:
- Self-reported medical diagnosis of stage II or stage III melanoma
- Have been resected (had surgery) for their melanoma within 12 months prior to study participation
Exclusion Criteria:
- Self-reported stage IIa
- Self-reported recurrence of melanoma after surgery
Other protocol-defined inclusion/exclusion criteria apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Cohort 1
Participants diagnosed with stage II and stage III melanoma who have undergone surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Preference weights or utilities (a measure of relative preference; on a continuous variable scale) for each treatment attribute level based on responses to the Discrete Choice Experiment (DCE) choice tasks
Time Frame: At Baseline
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At Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 7, 2021
Primary Completion (Actual)
June 2, 2022
Study Completion (Actual)
June 2, 2022
Study Registration Dates
First Submitted
October 28, 2021
First Submitted That Met QC Criteria
November 9, 2021
First Posted (Actual)
November 10, 2021
Study Record Updates
Last Update Posted (Actual)
June 30, 2022
Last Update Submitted That Met QC Criteria
June 29, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CA209-8YR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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