Kidney TumorNCT05387863
Decision Aid (DA) for Renal Patients
A study testing Decision Aid (DA) Web Tool and Institutional Pamphlet in people with Kidney Tumor and Renal Cancer, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Tumor, Renal Cancer
- What is being tested?
- Decision Aid (DA) Web Tool and Institutional Pamphlet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2022to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Stage IV cancer of any type
- Inability to provide informed consent
- Vulnerable subjects will not be recruited
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
Stella Kang, MD, Stella.kang@nyulangone.org
Samantha Sanger, Samantha.sanger@nyulangone.org
About this study
Official title: Evaluation of a Decision Aid in the Treatment Planning of Small Renal Tumors
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
- Being tested
- Decision Aid (DA) Web Tool, Institutional Pamphlet
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Aid (DA) Web ToolOther
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 PamphletOther
The institutional pamphlet provides information on kidney masses, but does not use risk communication, directed teaching, or interactive benefit-harm assessment.
| Study group | Role | What they receive |
|---|---|---|
| Decision Aid (DA) Web Tool | Experimental | Not described Receives: Other: Decision Aid (DA) Web Tool |
| Institutional Pamphlet | Active comparator | Not described Receives: Other: Institutional Pamphlet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Post-Counsel, 1 day Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start12 Sep 2022
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TumorStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stella Kang, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387863
- Sponsor's protocol ID
- 21-01670
- Status last verified
- Nov 2025
- First submitted
- 19 May 2022
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Publications
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 36053558
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Decision Aid in the Treatment Planning of Small Renal Tumors
- ClinicalTrials.gov ID
- NCT05387863
- Acronym / sponsor ID
- 21-01670
- Conditions
- Kidney Tumor, Renal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision Aid (DA) Web Tool | Experimental | Other: Decision Aid (DA) Web Tool |
| Institutional Pamphlet | Active comparator | Other: Institutional Pamphlet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Stage IV cancer of any type
- Inability to provide informed consent
- Vulnerable subjects will not be recruited
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision Aid (DA) Web ToolThe 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. | Other | Decision Aid (DA) Web Tool |
| Institutional PamphletThe institutional pamphlet provides information on kidney masses, but does not use risk communication, directed teaching, or interactive benefit-harm assessment. | Other | Institutional Pamphlet |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Derived from this study: PubMed 36053558Fogarty 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stella Kang, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid (DA) Web Tool and Institutional Pamphlet in people with Kidney Tumor and Renal Cancer, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stella Kang, MD (212-263-6246, Stella.kang@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge Score (time frame: Pre-Counsel, 1 day Visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05387863, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.