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
Qualifiers
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
Treatments tested in this trial
- Decision Aid
Treatment groups
66 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov