Clincosm LogoSign in Get a demo

Patient-Centered Communication of Life Expectancy Estimates in Genitourinary Malignancies

Sponsor
Cedars-Sinai Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03522155
Collaborator
(none)
136
Enrollment
1
Location
2
Arms
24.9
Anticipated Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Patient-centered communication of life expectancy
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
136 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
A Patient-Centered Approach to Integration of Life Expectancy Into Treatment Decision Making for Patients With Genitourinary Malignancy
Anticipated Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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.

  2. 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)

  3. 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)

  4. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cedars-Sinai Medical Center Los Angeles California United States 90048

Sponsors and Collaborators

  • Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Timothy Daskivich, MD, MSHPM, Cedars-Sinai Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Timothy J. Daskivich, Principal Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT03522155
Other Study ID Numbers:
  • Pro00052777
First Posted:
May 11, 2018
Last Update Posted:
Feb 6, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Timothy J. Daskivich, Principal Investigator, Cedars-Sinai Medical Center
Conjoint Analysis
Life Expectancy
Patient-centered
Additional relevant MeSH terms:
Prostatic Neoplasms
Kidney Neoplasms

Study Results

No Results Posted as of Feb 6, 2020