Patient-Centered Communication of Life Expectancy Estimates in Genitourinary Malignancies

Not Applicable

• Conditions: Prostate Cancer Stage I; Kidney Cancer Stage I; Prostate Cancer Stage II; Bladder Cancer Stage II

• Registration Number: NCT03522155
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2018-04-18
• Study First Submitted QC: 2018-04-30
• Study First Posted: 2018-05-11
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-05
• Last Update Posted: 2020-02-06
• Study Start: 2021-09-01
• Primary Completion: 2022-09-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 136

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Decisional Conflict	At time of treatment decision, up to 12 weeks after diagnosis	Decisional conflict evaluated based on the total decisional conflict score (DCS). The scale measures the degree of certainty/uncertainty an individual feels in selecting choices, feelings of being uninformed or unclear about values, and feelings of satisfaction with the selected decision. Scores range from 0 to 100. A total score of 0 indicates no decisional conflict, while a score of 100 indicates extremely high levels of decisional conflict.

Secondary Outcome Measures

Name	Time	Method
Number of questions asked about life expectancy	At time of treatment decision, up to 12 weeks after diagnosis	Difference in number of questions asked about life expectancy
Mention of life expectancy	At time of treatment decision, up to 12 weeks after diagnosis	Difference in odds of mention of life expectancy (binary variable)
Time devoted to life expectancy	At time of treatment decision, up to 12 weeks after diagnosis	Difference in proportion of time devoted to discussion of life expectancy (minutes discussed/total minutes)
Treatment Choice	At time of treatment decision, up to 12 weeks after diagnosis	The investigator will look at the difference in odds of aggressive vs. non-aggressive treatment. Aggressive treatment will be defined as surgery, radiation or ablative therapy; non-aggressive treatment will be defined as active surveillance, watchful waiting, or medical management.

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States