Clinical trial NCT03522155: Patient-Centered Communication of Life Expectancy Estimates in Genitourinary Malignancies
Official title: A Patient-Centered Approach to Integration of Life Expectancy Into Treatment Decision Making for Patients With Genitourinary Malignancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer Stage I
Kidney Cancer Stage I
Bladder Cancer Stage II
Prostate Cancer Stage II
Keywords: Conjoint Analysis
Life Expectancy
Patient-centered
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This randomized controlled trial will involve two arms: (1) an intervention arm consisting of a patient-centered communication strategy for life expectancy and (2) standard of care treatment counseling. The intervention will be randomized at the level of the patient to balance study arms in terms of measured and unmeasured patient characteristics.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Decisional Conflict
timeFrame: At time of treatment decision, up to 12 weeks after diagnosis
Secondary outcomes:
measure: Treatment Choice
timeFrame: At time of treatment decision, up to 12 weeks after diagnosis
measure: Mention of life expectancy
timeFrame: At time of treatment decision, up to 12 weeks after diagnosis
measure: Time devoted to life expectancy
timeFrame: At time of treatment decision, up to 12 weeks after diagnosis
measure: Number of questions asked about life expectancy
timeFrame: At time of treatment decision, up to 12 weeks after diagnosis
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Timothy Daskivich, MD, MSHPM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Daskivich TJ, Tan HJ, Litwin MS, Hu JC. Life Expectancy and Variation in Treatment for Early Stage Kidney Cancer. J Urol. 2016 Sep;196(3):672-7. doi: 10.1016/j.juro.2016.03.133. Epub 2016 Mar 21.
citation: Daskivich TJ, Lai J, Dick AW, Setodji CM, Hanley JM, Litwin MS, Saigal C; Urologic Diseases in America Project. Variation in treatment associated with life expectancy in a population-based cohort of men with early-stage prostate cancer. Cancer. 2014 Dec 1;120(23):3642-50. doi: 10.1002/cncr.28926. Epub 2014 Jul 17.
citation: Cho H, Klabunde CN, Yabroff KR, Wang Z, Meekins A, Lansdorp-Vogelaar I, Mariotto AB. Comorbidity-adjusted life expectancy: a new tool to inform recommendations for optimal screening strategies. Ann Intern Med. 2013 Nov 19;159(10):667-76. doi: 10.7326/0003-4819-159-10-201311190-00005.
citation: Ryan M, Farrar S. Using conjoint analysis to elicit preferences for health care. BMJ. 2000 Jun 3;320(7248):1530-3. doi: 10.1136/bmj.320.7248.1530. No abstract available.
citation: O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.