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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.
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:
After reviewing the decision aid and participating in a brief follow-up discussion with the clinician, patients will complete post-decision aid questionnaires, including:
A 30-day chart review will document whether SLNB was ultimately performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decision Aid Arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From the time of enrollment to the end of the intervention on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Sentinel lymph node biopsy knowledge questionnaire | Change in patient knowledge regarding sentinel lymph node biopsy. | From the time of enrollment to the end of the intervention on Day 1 |
| Consultation-related anxiety (STAI-6 questionnaire) |
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Inclusion Criteria:
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.
Patients with either:
Willingness and ability to comply with study procedures.
Ability to provide informed consent.
Pregnant women, and other vulnerable populations are not specifically excluded unless they meet other exclusion criteria; the study presents minimal risk.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evelyn Villalobos | Contact | 434-297-4579 | ev4pd@uvahealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Russell Witt, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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|
Change in consultation-related anxiety using the STAI-6 validated questionnaire
| From the time of enrollment to the end of the intervention on Day 1 |
| Sentinel lymph node biopsy decision | The proportion of patient participants who elect to undergo sentinel lymph node biopsy after decision aid-supported consultation | 30 days post-clinic visit |
| 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. | Within 48 hours of the intervention on Day 1 |
| Feasibility of Decision Aid implementation in the clinic workflow | Proportion of eligible patients successfully completing review of the decision aid during the clinic visit | From the time of enrollment to the end of the intervention on Day 1 |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |