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NCT Number: NCT05387863

Decision Aid (DA) for Renal Patients

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.

Recruiting

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Key information

Conditions

Kidney Tumor Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Renal Cancer Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Location contact

Samantha Sanger

CONTACT

[email protected]

Stella Kang, MD

CONTACT

[email protected]

Stella Kang, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decision Aid (DA) Web Tool

Other

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

Other

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

Primary outcomes

  1. Knowledge Score

    Time frame: Pre-Counsel, 1 day Visit

    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.

  2. Decision Satisfaction Score

    Time frame: Post-Counsel, 1 day Visit

    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.

  3. Shared Decision Making

    Time frame: Post-Counsel, 1 day Visit

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Samantha Sanger

CONTACT

[email protected]

646-501-0086

Stella Kang, MD

CONTACT

[email protected]

212-263-6246

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 24, 2022
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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