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

NCT07653087 | Not Yet Recruiting DMC

• 1 other identifier: HSR302710
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sentinel Lymph Node Biopsy (SLNB); Melanoma (Skin Cancer)

Keywords

SLNB; Melanoma; Sentinel Lymph Node Biopsy; Decision Aid

Outcome Measures

Primary Outcomes (1)

• Decisional conflict score

  Change in decisional conflict score from pre-decision aid to post-decision aid, measured using a validated questionnaire (Decisional Conflict Scale - DCS).

  From the time of enrollment to the end of the intervention on Day 1

Secondary Outcomes (5)

• Sentinel lymph node biopsy knowledge questionnaire

  From the time of enrollment to the end of the intervention on Day 1

• Consultation-related anxiety (STAI-6 questionnaire)

  From the time of enrollment to the end of the intervention on Day 1

• Sentinel lymph node biopsy decision

  30 days post-clinic visit

• Patient-reported acceptability of the Decision Aid

  Within 48 hours of the intervention on Day 1

• Feasibility of Decision Aid implementation in the clinic workflow

  From the time of enrollment to the end of the intervention on Day 1

Study Arms (1)

Decision Aid Arm

EXPERIMENTAL

Participants in this arm will receive the Decision Aid intervention. Participants will be asked to complete pre- and post- intervention questionnaires. All participants will be assigned to this arm.

Other: Decision Aid

Interventions

Decision Aid OTHER

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.

Decision Aid Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥18 years old) with a histologically confirmed diagnosis of cutaneous melanoma.
• Clinical stage I or II disease, for whom sentinel lymph node biopsy (SLNB) is being considered.
• Patients with either:
• An estimated risk of sentinel lymph node metastasis between 5 and 10 percent based on the MIA risk calculator, or
• A discordant risk scenario will be defined as a case in which the individualized probability of sentinel lymph node metastasis predicted by the MIA model falls into a different risk category (\<5%, 5-10%, or \>10%) than the category suggested by clinicopathologic staging features used in NCCN guideline-based counseling.
• Willingness and ability to comply with study procedures.
• Ability to provide informed consent.

You may not qualify if:

• Patients with clinical evidence of nodal or distant metastatic disease at the time of consultation.
• Patients with prior sentinel lymph node biopsy or nodal surgery for the current melanoma diagnosis.
• Inability to speak or read English.
• Inability or unwillingness to provide informed consent.
• Prisoners

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Russell Witt, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evelyn Villalobos

CONTACT

434-297-4579; ev4pd@uvahealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 17, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)