NCT03522155

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
3.3 years until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

April 18, 2018

Last Update Submit

February 5, 2020

Conditions

Prostate Cancer Stage IKidney Cancer Stage IBladder Cancer Stage IIProstate Cancer Stage II

Keywords

Conjoint AnalysisLife ExpectancyPatient-centered

Outcome Measures

Primary Outcomes (1)

  • Decisional Conflict

    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 Outcomes (4)

  • Treatment Choice

    At time of treatment decision, up to 12 weeks after diagnosis

  • Mention of life expectancy

    At time of treatment decision, up to 12 weeks after diagnosis

  • Time devoted to life expectancy

    At time of treatment decision, up to 12 weeks after diagnosis

  • Number of questions asked about life expectancy

    At time of treatment decision, up to 12 weeks after diagnosis

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Standard-of-care Arm

NO INTERVENTION

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

Interventions

Patient-centered communication of life expectancyBEHAVIORAL

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 Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Under 18 years of age
  • Subjects with difficulty communicating or dementia
  • Non-English speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Related Publications (5)

  • 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.

    PMID: 27012644BACKGROUND

  • 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.

    PMID: 25042117BACKGROUND

  • 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.

    PMID: 24247672BACKGROUND

  • 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.

    PMID: 10834905BACKGROUND

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

    PMID: 7898294BACKGROUND

MeSH Terms

Conditions

Prostatic NeoplasmsKidney NeoplasmsUrinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesUrologic NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesUrologic DiseasesUrinary Bladder Diseases

Study Officials

  • Timothy Daskivich, MD, MSHPM

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy Daskivich, MD, MSHPM

CONTACT

(310) 423-4700timothy.daskivich@csmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 18, 2018

First Posted

May 11, 2018

Study Start

September 1, 2021

Primary Completion

September 30, 2022

Study Completion

September 30, 2023

Last Updated

February 6, 2020

Record last verified: 2020-02

Locations

US(1)