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Patient-Centered Communication of Life Expectancy Estimates in Genitourinary Malignancies

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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

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
Prostate Cancer Stage I Kidney Cancer Stage I Bladder Cancer Stage II Prostate Cancer Stage II Behavioral: Patient-centered communication of life expectancy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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
Estimated Study Start Date : September 1, 2021
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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)

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522155


Contacts
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Contact: Timothy Daskivich, MD, MSHPM (310) 423-4700 ext 3-4700 timothy.daskivich@csmc.edu

Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Timothy Daskivich, MD, MSHPM Cedars-Sinai Medical Center

Publications:
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Responsible Party: Timothy J. Daskivich, Principal Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03522155     History of Changes
Other Study ID Numbers: Pro00052777
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Timothy J. Daskivich, Cedars-Sinai Medical Center:
Conjoint Analysis
Life Expectancy
Patient-centered
Additional relevant MeSH terms:
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Prostatic Neoplasms
Kidney Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Urologic Neoplasms
Urologic Diseases
Kidney Diseases