Recruiting

Decision Aid

Sponsor:

NYU Langone Health

Code:

NCT05387863

Conditions

Kidney Tumor

Renal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Decision Aid (DA) Web Tool

Institutional Pamphlet

Study Details

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.

Conditions

Kidney Tumor

Renal Cancer

Study ID

NCT05387863

Start date

Sep 12, 2022

Status verified date

Nov, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Decision Aid (DA) Web Tool

active comparator: Institutional Pamphlet

Interventions

Decision 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.

Institutional Pamphlet

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

Primary outcome measure

  • Knowledge Score [ Time Frame: Pre-Counsel, 1 day Visit ]
  • Decision Satisfaction Score [ Time Frame: Post-Counsel, 1 day Visit ]
  • Shared Decision Making [ Time Frame: Post-Counsel, 1 day Visit ]

Central Contacts and Locations

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Principal Investigator:

Stella Kang, MD

More Information

Sponsor

NYU Langone Health

Last update posted

Dec 2, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2025-12-02.