Patient-Centered Communication of Life Expectancy Estimates in Genitourinary Malignancies

February 5, 2020 updated by: Timothy J. Daskivich, Cedars-Sinai Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decisional Conflict
Time Frame: 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.
At time of treatment decision, up to 12 weeks after diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Choice
Time Frame: 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.
At time of treatment decision, up to 12 weeks after diagnosis
Mention of life expectancy
Time Frame: At time of treatment decision, up to 12 weeks after diagnosis
Difference in odds of mention of life expectancy (binary variable)
At time of treatment decision, up to 12 weeks after diagnosis
Time devoted to life expectancy
Time Frame: 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)
At time of treatment decision, up to 12 weeks after diagnosis
Number of questions asked about life expectancy
Time Frame: At time of treatment decision, up to 12 weeks after diagnosis
Difference in number of questions asked about life expectancy
At time of treatment decision, up to 12 weeks after diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

April 18, 2018

First Submitted That Met QC Criteria

April 30, 2018

First Posted (Actual)

May 11, 2018

Study Record Updates

Last Update Posted (Actual)

February 6, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00052777

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Investigators on this project will follow the NIH Grants Policy Statement concerning the sharing of research data and will make available to the public the results of the collaborative research and any accompanying data supported by this grant if funded. Such data shall be available in a timely fashion to researchers and/or the public upon request, provided that (1) such data may not be available until the time that it is used in connection with publication(s), (2) such data may be withheld for a reasonable amount of time to evaluate the impact of disclosure on patentability consistent with the Bayh-Dole Act, and (3) such data will not include any information that could be used to identify individual participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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