Patient-Centered Communication of Life Expectancy Estimates in Genitourinary Malignancies

NCT ID: NCT03522155

Last Updated: 2020-02-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-09-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention Arm

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.

Group Type: EXPERIMENTAL

Patient-centered communication of life expectancy

Intervention Type: BEHAVIORAL

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.

Standard-of-care Arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Timothy J. Daskivich

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timothy Daskivich, MD, MSHPM

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Timothy Daskivich, MD, MSHPM

Role: CONTACT

timothy.daskivich@csmc.edu

(310) 423-4700 ext. 3-4700

Facility Contacts

Timothy Daskivich, MD, MSPHM

Role: primary

timothy.daskivich@cshs.org

310-423-4700 ext. 3-4700

References

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.

Reference Type: BACKGROUND

PMID: 27012644 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25042117 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24247672 (View on PubMed)

Ryan M, Farrar S. Using conjoint analysis to elicit preferences for health care. BMJ. 2000 Jun 3;320(7248):1530-3. doi: 10.1136/bmj.320.7248.1530. No abstract available.

Reference Type: BACKGROUND

PMID: 10834905 (View on PubMed)

O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.

Reference Type: BACKGROUND

PMID: 7898294 (View on PubMed)

Other Identifiers

Pro00052777

Identifier Type: -

Identifier Source: org_study_id