Patient-Centered Communication of Life Expectancy Estimates in Genitourinary Malignancies

Cedars-Sinai Medical Center

Status: Enrolling

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

Treatments: Behavioral: Patient-centered communication of life expectancy

Study type: Interventional

Funder types: Other

Identifiers

NCT03522155

Pro00052777

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

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.

Treatment:

Behavioral: Patient-centered communication of life expectancy

Standard-of-care Arm

No Intervention group

Description:

Patients in the standard-of-care arm will not receive an intervention and will receive the usual standard of care for treatment counseling.