Clinical trial · Interventional
Evaluating a Decision Aid for Sentinel Lymph Node Biopsy in Intermediate-Risk Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin Cancer) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| Sentinel Lymph Node Biopsy (SLNB) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decision Aid | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Decision Aid Arm
- description
- 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.
- interventionNames
- Other: Decision Aid
Primary outcomes (1)
- measure
- Decisional conflict score
- timeFrame
- From the time of enrollment to the end of the intervention on Day 1
- description
- Change in decisional conflict score from pre-decision aid to post-decision aid, measured using a validated questionnaire (Decisional Conflict Scale - DCS).
Secondary outcomes (5)
- measure
- Sentinel lymph node biopsy knowledge questionnaire
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available