Recruiting

Observational Study

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT03522155

Conditions

Prostate Cancer Stage I

Kidney Cancer Stage I

Bladder Cancer Stage II

Prostate Cancer Stage II

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Patient-centered communication of life expectancy

Study Details

Brief summary:

Investigators will conduct a randomized trial to determine if providing patient-specific life expectancy estimates during treatment counseling via a targeted, patient-centered communication approach improves shared decision making and reduces rates of overtreatment of genitourinary malignancies.

Conditions

Prostate Cancer Stage I

Kidney Cancer Stage I

Bladder Cancer Stage II

Prostate Cancer Stage II

Study ID

NCT03522155

Start date

Sep 1, 2021

Status verified date

Feb, 2020

Completion date

Sep 30, 2023

Anticipated

Primary completion date

Sep 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Newly diagnosed clinical T1-2 prostate adenocarcinoma with Gleason scores of 7 or less
  • Newly diagnosed clinical T1a kidney cancer or renal masses < 4cm
  • Newly diagnosed clinical T2 nonmetastatic urothelial carcinoma of the bladder

Exclusion Criteria:

  • Under 18 years of age
  • Subjects with difficulty communicating or dementia
  • Non-English speakers

Study Design

Enrollment

136 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention Arm

Intervention: (1) Subjects will be provided with patient-specific LE estimates, (2) counseling physicians will receive "talking points" to assist in meaningful communication of life expectancy, and (3) subjects will complete a computer-based conjoint analysis exercise prior to counseling.

no intervention: Standard-of-care Arm

Patients in the standard-of-care arm will not receive an intervention and will receive the usual standard of care for treatment counseling.

Interventions

Patient-centered communication of life expectancy

The intervention arm will test if patient-specific LE estimates via a targeted, patient-centered communication approach paired with LE-specific conjoint analysis data improves decisional conflict, quality of LE discussion, and reduces rates of overtreatment of Genitourinary malignancies.

Primary outcome measure

  • Decisional Conflict [ Time Frame: At time of treatment decision, up to 12 weeks after diagnosis ]

Central Contacts and Locations

Central contacts

Timothy Daskivich, MD, MSHPM

(310) 423-4700timothy.daskivich@csmc.edu

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Timothy Daskivich, MD, MSPHM

310-423-4700timothy.daskivich@cshs.org

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Feb 6, 2020

Last verified

Feb, 2020

Keywords

  • Conjoint Analysis
  • Life Expectancy
  • Patient-centered

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2020-02-06.