Melanoma (Skin Cancer), Sentinel Lymph Node Biopsy (SLNB)
Conditions
Keywords
SLNB, Melanoma, Sentinel Lymph Node Biopsy, Decision Aid
Brief summary
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.
Detailed description
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: * Decisional conflict questionnaire: A validated multi-item questionnaire that assesses uncertainty, clarity of values, feeling informed, and confidence in decision-making regarding sentinel lymph node biopsy. * Melanoma sentinel lymph node biopsy knowledge questionnaire: A brief study-specific knowledge assessment evaluating patient understanding of the purpose of sentinel lymph node biopsy, potential benefits, risks, and areas of uncertainty. * Anxiety questionnaire: (State Trait Anxiety Inventory \[STAI-6\]) A validated short-form questionnaire assessing situational anxiety related to the clinical consultation and upcoming decision. * Health literacy assessment: A brief validated word-recognition screening tool to assess health literacy. * Demographic and contextual factors: Including residential zip code (for rurality and travel distance), insurance category, and basic socioeconomic indicators. After reviewing the decision aid and participating in a brief follow-up discussion with the clinician, patients will complete post-decision aid questionnaires, including: * Decisional conflict questionnaire (post): Re-administered to assess change in decisional conflict following use of the decision aid. * Melanoma sentinel lymph node biopsy knowledge questionnaire (post): Re-administered to assess change in knowledge. * Anxiety questionnaire (post): Re-administered to assess whether use of the decision aid increases, decreases, or does not change anxiety levels. * Final decision regarding sentinel lymph node biopsy: Documented as proceeding with or declining the procedure. * Decision Aid Evaluation form: a brief written questionnaire assessing usability, clarity, perceived value of the DA. A 30-day chart review will document whether SLNB was ultimately performed.
Interventions
OTHERDecision Aid
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.
Sponsors
University of Virginia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decisional conflict score | From the time of enrollment to the end of the intervention on Day 1 | Change in decisional conflict score from pre-decision aid to post-decision aid, measured using a validated questionnaire (Decisional Conflict Scale - DCS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sentinel lymph node biopsy knowledge questionnaire | From the time of enrollment to the end of the intervention on Day 1 | Change in patient knowledge regarding sentinel lymph node biopsy. |
| Consultation-related anxiety (STAI-6 questionnaire) | From the time of enrollment to the end of the intervention on Day 1 | Change in consultation-related anxiety using the STAI-6 validated questionnaire |
| Sentinel lymph node biopsy decision | 30 days post-clinic visit | The proportion of patient participants who elect to undergo sentinel lymph node biopsy after decision aid-supported consultation |
| Patient-reported acceptability of the Decision Aid | Within 48 hours of the intervention on Day 1 | 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. |
| Feasibility of Decision Aid implementation in the clinic workflow | From the time of enrollment to the end of the intervention on Day 1 | Proportion of eligible patients successfully completing review of the decision aid during the clinic visit |
Countries
United States
Contacts
CONTACTEvelyn Villalobos
PRINCIPAL_INVESTIGATORRussell Witt, MD
University of Virginia
Outcome results
None listed