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NOT YET RECRUITING
NCT07653087
NA

Evaluating a Decision Aid for Sentinel Lymph Node Biopsy in Intermediate-Risk Melanoma

Sponsor: University of Virginia

View on ClinicalTrials.gov

Summary

This research study is testing a decision aid to help patients think through whether to have sentinel lymph node biopsy for melanoma. Sentinel lymph node biopsy (SLNB) can be a difficult decision for some patients because the potential benefits and risks may not be clear. This study is being done to learn whether providing structured, easy-to-understand information helps patients feel more informed and less uncertain about their decision. Patients in this study will be given a paper decision aid (DA). Patients will be given other short questionnaires to complete before and after the decision aid.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2026-06

Completion Date

2028-01

Last Updated

2026-06-17

Healthy Volunteers

No

Interventions

OTHER

Decision Aid

The melanoma-specific decision aid is a structured, evidence-based informational tool designed to support shared decision-making regarding sentinel lymph node biopsy. The DA is a paper based tool that includes: (1) a plain-language explanation of melanoma staging and the purpose of SLNB; (2) individualized estimates of SLNB positivity risk based on the MIA risk model; (3) a balanced presentation of the potential benefits, risks, and uncertainties associated with SLNB; and (4) a values clarification component prompting patients to reflect on personal preferences related to risk tolerance, diagnostic certainty, and potential downstream treatment implications. The decision aid is provided to patients prior to surgical consultation and is reviewed during the clinic visit to facilitate structured discussion between the patient and surgeon. The decision aid does not provide treatment recommendations and does not replace physician counseling.

Locations (1)

University of Virginia Health System

Charlottesville, Virginia, United States