Evaluating a Decision Aid for Sentinel Lymph Node Biopsy in Intermediate-Risk Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •; 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.
研究者
Russell G. Witt
Assistant Professor
University of Virginia