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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Evelyn Villalobos
- 電話番号：434-297-4579
- メール：ev4pd@uvahealth.org
研究場所
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Virginia
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Charlottesville、Virginia、アメリカ、22908
- University of Virginia Health System
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
|
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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Decisional conflict score
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sentinel lymph node biopsy knowledge questionnaire
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Russell Witt, MD、University of Virginia
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- HSR302710
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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黒色腫 (皮膚がん)の臨床試験
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Novartis Pharmaceuticals終了しましたメラノーマ | 高度なEGFR変異体非小さな細胞肺cancer（NSCLC） | KRAS G12変異NSCLC | 食道扁平上皮がん（SCC） | ヘッド/ネックSCC | 進行した胃腸間質腫瘍（GIST） | 進行したNRAS/BRAFT WT皮膚黒色腫アメリカ, 台湾, オランダ, カナダ, スペイン, シンガポール, イタリア, 日本, 韓国
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
Decision Aidの臨床試験
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Washington University School of MedicineNational Cancer Institute (NCI)募集
-
Fondazione Poliambulanza Istituto Ospedaliero完了
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Kaiser PermanenteNational Institute of Mental Health (NIMH); University of Washington招待による登録
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University of Alabama at BirminghamNational Cancer Institute (NCI)積極的、募集していない
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University of Texas at Austin積極的、募集していない