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BRIEF TITLE: A Patient-Centered Approach to Integration of Life Expectancy Into Treatment Decision Making for Patients With Genitourinary Malignancy

A Patient-Centered Approach to Integration of Life Expectancy Into Treatment Decision Making for Patients With Genitourinary Malignancy


  • Org Study ID: Pro00052777
  • Secondary ID:
  • NCT ID: NCT03522155
  • NCT Alias:
  • Sponsor: Cedars-Sinai Medical Center - Other
  • Source: Cedars-Sinai Medical Center

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.

Detailed Description


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 Outcomes:

Primary Outcome 1 - Measure: Decisional Conflict

Primary Outcome 1 - Time Frame: At time of treatment decision, up to 12 weeks after diagnosis

Condition:

  • Prostate Cancer Stage I
  • Kidney Cancer Stage I
  • Bladder Cancer Stage II
  • Prostate Cancer Stage II

Eligibility

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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Timothy Daskivich, MD, MSHPM

Role: Principal Investigator

Affiliation: Cedars-Sinai Medical Center

Overall Contact

Name: Timothy Daskivich, MD, MSHPM

Phone: (310) 423-4700

Email: timothy.daskivich@csmc.edu

Location

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