RecruitingInterventional

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

NCT ID: NCT05387863Sponsor: NYU Langone HealthLast updated: 2025-12-02

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.

Arms & 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.

Outcome measures

Primary

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 Visit
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 Visit
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 Visit

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (1)

NYU Langone Health

New York, New York, 10016

Recruiting

Stella Kang, MD · Contact

Stella.kang@nyulangone.org

Samantha Sanger · Contact

Samantha.sanger@nyulangone.org

Stella Kang, MD · Principal Investigator

References

Fogarty J, Siriruchatanon M, Makarov D, Langford A, Kang S. An Evaluation of a Web-Based Decision Aid for Treatment Planning of Small Kidney Tumors: Pilot Randomized Controlled Trial. JMIR Res Protoc. 2022 Sep 2;11(9):e41451. doi: 10.2196/41451.(PubMed)