Patient-Centered Communication of Life Expectancy Estimates in Genitourinary Malignancies

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03522155
• Other study ID #: Pro00052777
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2020
• Source: Cedars-Sinai Medical Center
• Contact: Timothy Daskivich, MD, MSHPM
• Phone: (310) 423-4700
• Email: timothy.daskivich[@]csmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Bladder Cancer Stage II
• Kidney Cancer Stage I
• Kidney Neoplasms
• Prostate Cancer Stage I
• Prostate Cancer Stage II
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

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

Outcome

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