Bladder Cancer Stage II, Kidney Cancer Stage I, Prostate Cancer Stage I, Prostate Cancer Stage II
Conditions
Keywords
Conjoint Analysis, Life Expectancy, Patient-centered
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.
Interventions
BEHAVIORALPatient-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.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
| 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 |
Countries
United States
Contacts
Primary ContactTimothy Daskivich, MD, MSHPM
Outcome results
None listed