Decision Aid (DA) for Renal Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health
About this trial
The objective of this study is to understand how patients make decisions about treating their kidney masses, and to identify key values and preferences for treating their kidney masses. The study team will develop a decision aid (DA) using the decision-analytic model to communicate personalized benefit/harm estimates to patients and promote patient-centered treatment of renal tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female post-op and pre-op patients, ages 18 and older, diagnosed with a localized renal tumor up to 4 cm in diameter.
Patients scheduled for standard-of-care clinical exams with the NYU Urology Department
Disqualifiers
Stage IV cancer of any type
Inability to provide informed consent
Vulnerable subjects will not be recruited
Trial design
Design model
Parallel
Treatments tested in this trial
Decision Aid (DA) Web Tool
Other interventionThe DA web tool provides information on kidney masses and available treatment options. It uses risk communication, directed teaching, and interactive benefit-harm assessment to present information.
Institutional Pamphlet
Other interventionThe institutional pamphlet provides information on kidney masses, but does not use risk communication, directed teaching, or interactive benefit-harm assessment.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Decision Aid (DA) Web ToolExperimental treatment 1 intervention
Group B: Institutional PamphletActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Knowledge Score
Via a survey, patients will be asked general questions about kidney masses and their treatments. There are 10 questions, each scored as correct or incorrect (0 or 1), and the last question has 3 sub-components each scored 0-1. The total range of score is 0-10; a score of 10 indicates strongest knowledge on kidney masses/treatments.
Time frame
Pre-Counsel, 1 day Visit2
Decision Satisfaction Score
Via a survey, patients provide their opinion on 16 statements. Each statement is scored 1 (strongly disagree) to 5 (strongly agree). The total range of score is 1-80; a higher score indicates higher satisfaction.
Time frame
Post-Counsel, 1 day Visit3
Shared Decision Making
This is a binary outcome measure. Patients will be asked whether or not they felt they participated in a shared decision making process: 0 for no, 1 for yes.
Time frame
Post-Counsel, 1 day VisitSponsors and contacts
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Source ClinicalTrials.gov