Patient-Centered Communication of Life Expectancy Estimates in Genitourinary Malignancies

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer Stage I, Kidney Cancer Stage I, Bladder Cancer Stage II, Prostate Cancer Stage II

Intervention / Treatment
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* Behavioral: Patient-centered communication of life expectancy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>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<br>* 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.<br>|
| No Intervention: Standard-of-care Arm<br>Patients in the standard-of-care arm will not receive an intervention and will receive the usual standard of care for treatment counseling. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional Conflict | 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. | At time of treatment decision, up to 12 weeks after diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Choice | 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. | At time of treatment decision, up to 12 weeks after diagnosis | 
| Mention of life expectancy | Difference in odds of mention of life expectancy (binary variable) | At time of treatment decision, up to 12 weeks after diagnosis | 
| Time devoted to life expectancy | Difference in proportion of time devoted to discussion of life expectancy (minutes discussed/total minutes) | At time of treatment decision, up to 12 weeks after diagnosis | 
| Number of questions asked about life expectancy | Difference in number of questions asked about life expectancy | At time of treatment decision, up to 12 weeks after diagnosis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Conjoint Analysis, Life Expectancy, Patient-centered