Evaluating a Decision Aid for Sentinel Lymph Node Biopsy in Intermediate-Risk Melanoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Virginia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Decision Aid
Other interventionThe 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.
Treatment groups
66 Participants
are divided into 1 treatment groupGroup A: Decision Aid ArmExperimental treatment 1 intervention
Trial outcomes
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).
Time frame
From the time of enrollment to the end of the intervention on Day 1Secondary outcomes
1
Sentinel lymph node biopsy knowledge questionnaire
Change in patient knowledge regarding sentinel lymph node biopsy.
Time frame
From the time of enrollment to the end of the intervention on Day 12
Consultation-related anxiety (STAI-6 questionnaire)
Change in consultation-related anxiety using the STAI-6 validated questionnaire
Time frame
From the time of enrollment to the end of the intervention on Day 13
Sentinel lymph node biopsy decision
The proportion of patient participants who elect to undergo sentinel lymph node biopsy after decision aid-supported consultation
Time frame
30 days post-clinic visit4
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.
Time frame
Within 48 hours of the intervention on Day 1Sponsors and contacts
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Source ClinicalTrials.gov
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