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Evaluating a Decision Aid for Sentinel Lymph Node Biopsy in Intermediate-Risk Melanoma (Mel73)

11 juni 2026 uppdaterad av: Russell G. Witt, University of Virginia

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

66

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • Virginia
      • Charlottesville, Virginia, Förenta staterna, 22908
        • University of Virginia Health System

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Exclusion Criteria:

  1. Patients with clinical evidence of nodal or distant metastatic disease at the time of consultation.
  2. Patients with prior sentinel lymph node biopsy or nodal surgery for the current melanoma diagnosis.
  3. Inability to speak or read English.
  4. Inability or unwillingness to provide informed consent.
  5. Prisoners

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Övrig: Decision 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Decisional conflict score
Tidsram: 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).
From the time of enrollment to the end of the intervention on Day 1

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Sentinel lymph node biopsy knowledge questionnaire
Tidsram: From the time of enrollment to the end of the intervention on Day 1
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)
Tidsram: 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
From the time of enrollment to the end of the intervention on Day 1
Sentinel lymph node biopsy decision
Tidsram: 30 days post-clinic visit
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
Tidsram: 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.
Within 48 hours of the intervention on Day 1
Feasibility of Decision Aid implementation in the clinic workflow
Tidsram: 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
From the time of enrollment to the end of the intervention on Day 1

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Virginia

Utredare

  • Huvudutredare: Russell Witt, MD, University of Virginia

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juni 2026

Primärt slutförande (Beräknad)

1 januari 2028

Avslutad studie (Beräknad)

1 januari 2028

Studieregistreringsdatum

Först inskickad

8 juni 2026

Först inskickad som uppfyllde QC-kriterierna

11 juni 2026

Första postat (Faktisk)

17 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • HSR302710

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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