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

11 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

66

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Evelyn Villalobos
  • Número de teléfono: 434-297-4579
  • Correo electrónico: ev4pd@uvahealth.org

Ubicaciones de estudio

  • Estados Unidos
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22908
        • University of Virginia Health System

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Decisional conflict score
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Sentinel lymph node biopsy knowledge questionnaire
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Virginia

Investigadores

  • Investigador principal: Russell Witt, MD, University of Virginia

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

1 de enero de 2028

Finalización del estudio (Estimado)

1 de enero de 2028

Fechas de registro del estudio

Enviado por primera vez

8 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

11 de junio de 2026

Publicado por primera vez (Actual)

17 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

11 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HSR302710

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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