Patient-Centered Communication of Life Expectancy Estimates in Genitourinary Malignancies
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|ClinicalTrials.gov Identifier: NCT03522155|
Recruitment Status : Not yet recruiting
First Posted : May 11, 2018
Last Update Posted : May 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Stage I Kidney Cancer Stage I Bladder Cancer Stage II Prostate Cancer Stage II||Behavioral: Patient-centered communication of life expectancy||Not Applicable|
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 (1,2), and life expectancy for bladder cancer patients will be determined using definitions as noted by Cho et al (3). 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 (4). 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 (5). 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||136 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Patient-Centered Approach to Integration of Life Expectancy Into Treatment Decision Making for Patients With Genitourinary Malignancy|
|Estimated Study Start Date :||September 1, 2021|
|Estimated Primary Completion Date :||September 30, 2022|
|Estimated Study Completion Date :||September 30, 2023|
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.
Behavioral: 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.
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.
- Decisional Conflict [ Time Frame: At time of treatment decision, up to 12 weeks after diagnosis ]Decisional conflict evaluated based on the total decisional conflict score (DCS).
- Treatment Choice [ Time Frame: 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.
- Mention of life expectancy [ Time Frame: 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 [ Time Frame: 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)
- Number of questions asked about life expectancy [ Time Frame: At time of treatment decision, up to 12 weeks after diagnosis ]Difference in number of questions asked about life expectancy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522155
|Contact: Timothy Daskivich, MD, MSHPM||(310) 423-4700 ext firstname.lastname@example.org|
|Principal Investigator:||Timothy Daskivich, MD, MSHPM||Cedars-Sinai Medical Center|