Evaluating a Decision Aid for Sentinel Lymph Node Biopsy in Intermediate-Risk Melanoma (Mel73)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Melanoma (Skin Cancer); Sentinel Lymph Node Biopsy (SLNB)
• Intervention / Treatment: Other: Decision Aid

Detailed Description

The melanoma-specific decision aid (DA) is a structured, evidence-based informational tool designed to support shared decision-making regarding sentinel lymph node biopsy (SLNB). The DA 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.

Immediately after written informed consent and before reviewing the decision aid, patients will complete baseline questionnaires reflecting their understanding and feelings following standard-of-care counseling alone. These baseline measures include:

• Decisional conflict questionnaire: A validated multi-item questionnaire that assesses uncertainty, clarity of values, feeling informed, and confidence in decision-making regarding sentinel lymph node biopsy.
• Melanoma sentinel lymph node biopsy knowledge questionnaire: A brief study-specific knowledge assessment evaluating patient understanding of the purpose of sentinel lymph node biopsy, potential benefits, risks, and areas of uncertainty.
• Anxiety questionnaire: (State Trait Anxiety Inventory [STAI-6]) A validated short-form questionnaire assessing situational anxiety related to the clinical consultation and upcoming decision.
• Health literacy assessment: A brief validated word-recognition screening tool to assess health literacy.
• Demographic and contextual factors: Including residential zip code (for rurality and travel distance), insurance category, and basic socioeconomic indicators.

After reviewing the decision aid and participating in a brief follow-up discussion with the clinician, patients will complete post-decision aid questionnaires, including:

• Decisional conflict questionnaire (post): Re-administered to assess change in decisional conflict following use of the decision aid.
• Melanoma sentinel lymph node biopsy knowledge questionnaire (post): Re-administered to assess change in knowledge.
• Anxiety questionnaire (post): Re-administered to assess whether use of the decision aid increases, decreases, or does not change anxiety levels.
• Final decision regarding sentinel lymph node biopsy: Documented as proceeding with or declining the procedure.
• Decision Aid Evaluation form: a brief written questionnaire assessing usability, clarity, perceived value of the DA.

A 30-day chart review will document whether SLNB was ultimately performed.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Evelyn Villalobos; Phone Number: 434-297-4579; Email: ev4pd@uvahealth.org

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults (≥18 years old) with a histologically confirmed diagnosis of cutaneous melanoma.
2. Clinical stage I or II disease, for whom sentinel lymph node biopsy (SLNB) is being considered.

3. 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.
4. Willingness and ability to comply with study procedures.
5. Ability to provide informed consent.
6. Pregnant women, and other vulnerable populations are not specifically excluded unless they meet other exclusion criteria; the study presents minimal risk.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Decision Aid Arm; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sentinel lymph node biopsy knowledge questionnaire	Change in patient knowledge regarding sentinel lymph node biopsy.	From the time of enrollment to the end of the intervention on Day 1
Consultation-related anxiety (STAI-6 questionnaire)	Change in consultation-related anxiety using the STAI-6 validated questionnaire	From the time of enrollment to the end of the intervention on Day 1
Sentinel lymph node biopsy decision	The proportion of patient participants who elect to undergo sentinel lymph node biopsy after decision aid-supported consultation	30 days post-clinic visit
Patient-reported acceptability of the Decision Aid	The Decision Aid Evaluation Form will be used to describe patient-reported acceptability of the decision aid. This questionnaire utilizes Likert-scale items and an optional, written, free-text response section.	Within 48 hours of the intervention on Day 1
Feasibility of Decision Aid implementation in the clinic workflow	Proportion of eligible patients successfully completing review of the decision aid during the clinic visit	From the time of enrollment to the end of the intervention on Day 1

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Russell Witt, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Melanoma; Decision Aid; Sentinel Lymph Node Biopsy; SLNB
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Melanoma; Investigative Techniques; Decision Support Techniques
• Other Study ID Numbers: HSR302710

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No