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

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.

• Sentinel lymph node biopsy knowledge questionnaire [Срок оценки: From the time of enrollment to the end of the intervention on Day 1]
• Consultation-related anxiety (STAI-6 questionnaire) [Срок оценки: From the time of enrollment to the end of the intervention on Day 1]
• Sentinel lymph node biopsy decision [Срок оценки: 30 days post-clinic visit]
• Patient-reported acceptability of the Decision Aid [Срок оценки: Within 48 hours of the intervention on Day 1]
• Feasibility of Decision Aid implementation in the clinic workflow [Срок оценки: From the time of enrollment to the end of the intervention on Day 1]