NCT06294379

Brief Summary

This study aims to develop test and evaluate a Patient Decision Aid called "The Decision Helper" among melanoma patients eligible for adjuvant treatment.

  • Is the Decision Helper an acceptable tool for patients and clinicians and is it feasible in clinical practice?
  • Are there any differences in the levels of decisional regret in the patients who have not used the Decision Helper (pre-implementation) compared to the ones who have (post-implementation?

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

March 5, 2024

Status Verified

February 1, 2024

Enrollment Period

2.8 years

First QC Date

December 19, 2023

Last Update Submit

February 27, 2024

Conditions

Malignant Melanoma

Outcome Measures

Primary Outcomes (2)

  • Development of a Patient Decision Aid "The Decision Helper" for melanoma patients receiving adjuvant theory

    To develop a Patient Decision Aid for melanoma patients receiving adjuvant theory

    1 year

  • Evaluation of the "The Decision Helper"

    To evaluate "The Decision Helper among patients and healthcare professionals"

    1 year

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients diagnosed with malignant melanoma who at about to receive adjuvant therapy with immunotherapy or targeted therapy

You may qualify if:

  • Danish speaking
  • Diagnosed with stage 3 malignant melanoma
  • Eligible for adjuvant immunotherapy

You may not qualify if:

  • Metastatic disease
  • Mental impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense C, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Lærke K Tolstrup, PhD

CONTACT

40295129laerke.tolstrup@rsyd.dk

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2023

First Posted

March 5, 2024

Study Start

March 1, 2022

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

March 5, 2024

Record last verified: 2024-02

Locations

DK(1)