Evaluating a Decision Aid for Sentinel Lymph Node Biopsy in Intermediate-Risk Melanoma (Mel73)
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Evelyn Villalobos
- 电话号码：434-297-4579
- 邮箱：ev4pd@uvahealth.org
学习地点
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Virginia
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Charlottesville、Virginia、美国、22908
- University of Virginia Health System
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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:
- 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.
- 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:
- 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.
- Prisoners
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Decision Aid Arm
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.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Decisional conflict score
大体时间：From the time of enrollment to the end of the intervention on Day 1
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Change in decisional conflict score from pre-decision aid to post-decision aid, measured using a validated questionnaire (Decisional Conflict Scale - DCS).
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From the time of enrollment to the end of the intervention on Day 1
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Sentinel lymph node biopsy knowledge questionnaire
大体时间：From the time of enrollment to the end of the intervention on Day 1
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Change in patient knowledge regarding sentinel lymph node biopsy.
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From the time of enrollment to the end of the intervention on Day 1
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Consultation-related anxiety (STAI-6 questionnaire)
大体时间：From the time of enrollment to the end of the intervention on Day 1
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Change in consultation-related anxiety using the STAI-6 validated questionnaire
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From the time of enrollment to the end of the intervention on Day 1
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Sentinel lymph node biopsy decision
大体时间：30 days post-clinic visit
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The proportion of patient participants who elect to undergo sentinel lymph node biopsy after decision aid-supported consultation
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30 days post-clinic visit
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Patient-reported acceptability of the Decision Aid
大体时间：Within 48 hours of the intervention on Day 1
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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.
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Within 48 hours of the intervention on Day 1
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Feasibility of Decision Aid implementation in the clinic workflow
大体时间：From the time of enrollment to the end of the intervention on Day 1
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Proportion of eligible patients successfully completing review of the decision aid during the clinic visit
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From the time of enrollment to the end of the intervention on Day 1
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合作者和调查者
调查人员
- 首席研究员：Russell Witt, MD、University of Virginia
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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