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

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT07653087
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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 Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
66 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Decisional conflict score [ Time Frame: From the time of enrollment to the end of the intervention on Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Virginia Health SystemCharlottesvilleVirginia22908-

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University of Virginia Health System· Charlottesville, VA

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