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Decision Aid (DA) for Renal Patients

Evaluation of a Decision Aid in the Treatment Planning of Small Renal Tumors

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05387863
Enrollment
40
Registered
2022-05-24
Start date
2022-09-12
Completion date
2026-09-30
Last updated
2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Tumor, Renal Cancer

Brief summary

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.

Interventions

OTHERDecision Aid (DA) Web Tool

The 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.

OTHERInstitutional Pamphlet

The institutional pamphlet provides information on kidney masses, but does not use risk communication, directed teaching, or interactive benefit-harm assessment.

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Stage IV cancer of any type * Inability to provide informed consent * Vulnerable subjects will not be recruited

Design outcomes

Primary

MeasureTime frameDescription
Knowledge ScorePre-Counsel, 1 day VisitVia 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.
Decision Satisfaction ScorePost-Counsel, 1 day VisitVia 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.
Shared Decision MakingPost-Counsel, 1 day VisitThis 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.

Countries

United States

Contacts

Primary ContactStella Kang, MD
Stella.kang@nyulangone.org212-263-6246
Backup ContactSamantha Sanger
Samantha.sanger@nyulangone.org646-501-0086

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026