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Patient-Centered Communication of Life Expectancy Estimates in Genitourinary Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03522155
Recruitment Status : Not yet recruiting
First Posted : May 11, 2018
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Timothy J. Daskivich, Cedars-Sinai Medical Center

Tracking Information
First Submitted Date  ICMJE April 18, 2018
First Posted Date  ICMJE May 11, 2018
Last Update Posted Date May 11, 2018
Estimated Study Start Date  ICMJE September 1, 2021
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2018)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2018)
  • 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.
  • 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)
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patient-Centered Communication of Life Expectancy Estimates in Genitourinary Malignancies
Official Title  ICMJE A Patient-Centered Approach to Integration of Life Expectancy Into Treatment Decision Making for Patients With Genitourinary Malignancy
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 (1,2), and life expectancy for bladder cancer patients will be determined using definitions as noted by Cho et al (3). 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 (4). 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 (5). 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Prostate Cancer Stage I
  • Kidney Cancer Stage I
  • Bladder Cancer Stage II
  • Prostate Cancer Stage II
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Patient-centered communication of life expectancy
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 30, 2018)
136
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2023
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Timothy Daskivich, MD, MSHPM (310) 423-4700 ext 3-4700 timothy.daskivich@csmc.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03522155
Other Study ID Numbers  ICMJE Pro00052777
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
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.
Responsible Party Timothy J. Daskivich, Cedars-Sinai Medical Center
Study Sponsor  ICMJE Cedars-Sinai Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Timothy Daskivich, MD, MSHPM Cedars-Sinai Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP