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.
Subjects in the intervention arm will be provided with life expectancy estimates specific to
their age and health status. Life expectancy estimates for prostate and kidney cancer
patients will be estimated by age and Charlson comorbidity score cutoffs, and life expectancy
for bladder cancer patients will be determined using definitions as noted by Cho et al.
Talking points will be provided to counseling physicians on how to meaningfully communicate
life expectancy data. Subjects will also complete a computer-based conjoint analysis exercise
prior to the counseling visit; results will be used to help physicians understand how the
subject values life expectancy compared with other decision attributes. The control arm will
consist of the current standard of care for treatment counseling.
The intervention will be randomized at the level of the patient after stratification by type
of cancer.
All participants will be asked to fill out a validated questionnaire to measure decisional
conflict at the conclusion of their counseling visit. Investigators will audiotape treatment
counseling visits to allow for qualitative analysis of the quality of communication of life
expectancy information. Treatment choice will be documented to assess rates of aggressive
versus non-aggressive treatment among patients with limited life expectancy.
| Overal Status | Start Date | Phase | Study Type |
|---|---|---|---|
| Recruiting | September 1, 2021 | N/A | Interventional |
Primary Outcome 1 - Measure: Decisional Conflict
Primary Outcome 1 - Time Frame: At time of treatment decision, up to 12 weeks after diagnosis
Criteria:
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
Show More
Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Timothy Daskivich, MD, MSHPM
Role: Principal Investigator
Affiliation: Cedars-Sinai Medical Center
Name: Timothy Daskivich, MD, MSHPM
Phone: (310) 423-4700
Email: timothy.daskivich@csmc.edu
| Facility | Status | Contact |
|---|---|---|
| Cedars-Sinai Medical Center Los Angeles, California 90048 United States |
Recruiting |
Timothy Daskivich, MD, MSPHM 310-423-4700 timothy.daskivich@cshs.org |
