Bladder Cancer Stage II Clinical Trial
Official title:
A Patient-Centered Approach to Integration of Life Expectancy Into Treatment Decision Making for Patients With Genitourinary Malignancy
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.
Status | Recruiting |
Enrollment | 136 |
Est. completion date | September 30, 2023 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Cedars-Sinai Medical Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Cedars-Sinai Medical Center |
United States,
Cho H, Klabunde CN, Yabroff KR, Wang Z, Meekins A, Lansdorp-Vogelaar I, Mariotto AB. Comorbidity-adjusted life expectancy: a new tool to inform recommendations for optimal screening strategies. Ann Intern Med. 2013 Nov 19;159(10):667-76. doi: 10.7326/0003-4819-159-10-201311190-00005. — View Citation
Daskivich TJ, Lai J, Dick AW, Setodji CM, Hanley JM, Litwin MS, Saigal C; Urologic Diseases in America Project. Variation in treatment associated with life expectancy in a population-based cohort of men with early-stage prostate cancer. Cancer. 2014 Dec 1;120(23):3642-50. doi: 10.1002/cncr.28926. Epub 2014 Jul 17. — View Citation
Daskivich TJ, Tan HJ, Litwin MS, Hu JC. Life Expectancy and Variation in Treatment for Early Stage Kidney Cancer. J Urol. 2016 Sep;196(3):672-7. doi: 10.1016/j.juro.2016.03.133. Epub 2016 Mar 21. — View Citation
O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. — View Citation
Ryan M, Farrar S. Using conjoint analysis to elicit preferences for health care. BMJ. 2000 Jun 3;320(7248):1530-3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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