Sentinel Lymph Node Biopsy (SLNB)Mel73NCT07653087
Evaluating a Decision Aid for Sentinel Lymph Node Biopsy in Intermediate-Risk Melanoma
A study testing Decision Aid in people with Sentinel Lymph Node Biopsy (SLNB) and Melanoma (Skin Cancer), run by University of Virginia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sentinel Lymph Node Biopsy (SLNB), Melanoma (Skin Cancer)
- What is being tested?
- Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
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.
Read the detailed description
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.
- Being tested
- Decision Aid
- Keywords
- SLNB, Melanoma, Sentinel Lymph Node Biopsy, Decision Aid
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision AidOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Decision Aid Arm | Experimental | 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. Receives: Other: Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional conflict score
Change in decisional conflict score from pre-decision aid to post-decision aid, measured using a validated questionnaire (Decisional Conflict Scale - DCS).
Measured: From the time of enrollment to the end of the intervention on Day 1
Secondary outcomes (5)
Sentinel lymph node biopsy knowledge questionnaire
Change in patient knowledge regarding sentinel lymph node biopsy.
Measured: From the time of enrollment to the end of the intervention on Day 1
Consultation-related anxiety (STAI-6 questionnaire)
Change in consultation-related anxiety using the STAI-6 validated questionnaire
Measured: From the time of enrollment to the end of the intervention on Day 1
Sentinel lymph node biopsy decision
The proportion of patient participants who elect to undergo sentinel lymph node biopsy after decision aid-supported consultation
Measured: 30 days post-clinic visit
Patient-reported acceptability of the Decision Aid
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.
Measured: Within 48 hours of the intervention on Day 1
Feasibility of Decision Aid implementation in the clinic workflow
Proportion of eligible patients successfully completing review of the decision aid during the clinic visit
Measured: From the time of enrollment to the end of the intervention on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sentinel Lymph Node Biopsy (SLNB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Russell G. Witt, University of Virginia
- Investigators
- Russell Witt, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653087
- Sponsor's protocol ID
- HSR302710
- Acronym
- Mel73
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Decision Aid for Sentinel Lymph Node Biopsy in Intermediate-Risk Melanoma
- ClinicalTrials.gov ID
- NCT07653087
- Acronym / sponsor ID
- Mel73 / HSR302710
- Keywords
- SLNB, Melanoma, Sentinel Lymph Node Biopsy, Decision Aid
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decision Aid Arm | Experimental | Other: Decision AidParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Willingness and ability to comply with study procedures.
- Ability to provide informed consent.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision AidThe 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. | Other | Decision Aid Arm |
Primary outcome
Decisional conflict score
Time frame: 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).
5 secondary outcomes
Sentinel lymph node biopsy knowledge questionnaire
Time frame: From the time of enrollment to the end of the intervention on Day 1
Consultation-related anxiety (STAI-6 questionnaire)
Time frame: From the time of enrollment to the end of the intervention on Day 1
Sentinel lymph node biopsy decision
Time frame: 30 days post-clinic visit
Patient-reported acceptability of the Decision Aid
Time frame: Within 48 hours of the intervention on Day 1
Feasibility of Decision Aid implementation in the clinic workflow
Time frame: From the time of enrollment to the end of the intervention on Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Russell Witt, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid in people with Sentinel Lymph Node Biopsy (SLNB) and Melanoma (Skin Cancer), run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evelyn Villalobos (434-297-4579, ev4pd@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional conflict score (time frame: From the time of enrollment to the end of the intervention on Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.