NCT05115006

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
294

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2022

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

1.4 years

First QC Date

October 28, 2021

Last Update Submit

June 29, 2022

Conditions

Melanoma

Keywords

MelanomaDiscrete choice experimentResected melanomaAdjuvant treatmentPatient preference

Outcome Measures

Primary Outcomes (1)

  • 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

    At Baseline

Study Arms (1)

Cohort 1

Participants diagnosed with stage II and stage III melanoma who have undergone surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Self-reported stage IIa
  • Self-reported recurrence of melanoma after surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Melbourne, Victoria, 3084, Australia

Location

Related Links

MeSH Terms

Conditions

MelanomaPatient Preference

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesPatient SatisfactionTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2021

First Posted

November 10, 2021

Study Start

January 7, 2021

Primary Completion

June 2, 2022

Study Completion

June 2, 2022

Last Updated

June 30, 2022

Record last verified: 2022-06

Locations

AU(1)