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Culturally Tailored Decision Aid for Hispanic Patients Diagnosed With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03157947
Recruitment Status : Recruiting
First Posted : May 17, 2017
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief Summary:
A pilot study testing the effect of an in-visit English and Spanish language decision aid for Hispanic-Latino men using best practices of cultural tailoring to be used in urology practice. Subjects will be followed for approximately 1 year during standard care in-clinic office visits. Study results and subject surveys will be analyzed to determine clinical utility of the tool.

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Decision Aid Tool Behavioral: baseline survey Behavioral: follow-up surveys Not Applicable

Detailed Description:

The objective of this research is to determine the effect of a culturally tailored decision aid tool on the cancer treatment decisions of Hispanic-Latino patients.

The specific aims are:

i. To develop and pilot test in an uncontrolled fashion an in-visit English and Spanish language decision aid for Hispanic-Latino men using best practices of cultural tailoring to be used in urology practice ii. To pilot and test the impact of a culturally tailored, English and Spanish language version of the Prostate Choice in-visit decision aid on decision quality, knowledge, and quality of life in low-income Hispanic/Latino patients diagnosed with localized prostate cancer iii. To assess the barriers and facilitators of decision aid use including the relative contribution of language-concordance on 1-year practice implementation parameters.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Development and Testing of a Culturally Tailored Decision Aid for Hispanic Patients Diagnosed With Prostate Cancer
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Decision Aid
Subjects will be asked to complete baseline surveys. Once the surveys are completed, subjects will review the Decision Aid tool with a study team member. Once the subjects have gone through the tool, study team members will answer any additional questions he may have regarding the tool. The subjects will then discuss with the investigator various cancer management options, quality of life implications, and any questions the subjects may have regarding cancer management options. Subjects that are ready may make a cancer management decision at this time, or choose to wait until their next scheduled visit. Subjects will be followed at subsequent urology clinic visits for up to 6 months. Subjects will complete follow-up surveys at the 3, 6, 9 and 12 month visits.
Behavioral: Decision Aid Tool
Subjects will be given an I-pad with the decision aid program on it. A member of the study team will enter some preliminary information, then the subject will be able to review the tool with his doctor.

Behavioral: baseline survey
patients will be given baseline surveys to gather demographic information and readiness to make a decision regarding prostate cancer care

Behavioral: follow-up surveys
at 3, 6, 9, and 12 months patients will be given follow-up surveys regarding prostate cancer care




Primary Outcome Measures :
  1. Decision Quality of cancer care in low-income Hispanic/Latino patients diagnosed with localized prostate cancer [ Time Frame: Up to 12 months ]
    Decisional quality will be measured by the O'Connor Decisional Conflict Scale

  2. Knowledge of prostate cancer care in low-income Hispanic/Latino patients diagnosed with localized prostate cancer [ Time Frame: Up to 12 months ]
    Prostate cancer knowledge will be measured by the Knowledge Measurement Tool

  3. Patient satisfaction in low-income Hispanic/Latino patients diagnosed with localized prostate cancer [ Time Frame: Up to 12 months ]
    Patient satisfaction will be measured by the CAPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor) patient satisfaction measurement tool


Secondary Outcome Measures :
  1. Quality of Life in low-income Hispanic/Latino patients diagnosed with localized prostate cancer [ Time Frame: Up to 12 months ]
    Health-related quality of life will be measured by the EPIC (Expanded Prostate Cancer Index Composite) assessment tool



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

Inclusion Criteria:

  • Subjects utilize English or Spanish as their primary spoken or written language and identify with a Latino ethnicity and/or culture
  • Men with a new histologic diagnosis of localized prostate cancer
  • PSA level of 0.1 - 50 ng/dl
  • Gleason score of 6 - 10
  • Cancer stage: T1 - 4N x M0

Exclusion Criteria:

  • Metastatic disease, including lymph nodes or distant metastasis
  • PSA > 50 ng/dl
  • Individuals with a medical condition that necessitates a specific prostate cancer treatment plan
  • Individuals that are unwilling or unable to attend study visits or are planning to move out of a study site coverage area during the subject's anticipated participation in the study

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): NCT03157947


Contacts
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Contact: Simon P Kim, MD, MPH 216-844-3009 Simon.Kim@uhhospitals.org

Locations
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United States, Illinois
John H. Stroger, Jr. Hospital of Cook County Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Sarah Psutka, MD    312-864-0913    spsutka@cookcountyhhs.org   
United States, Ohio
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Simon P Kim, MD, MPH    216-844-3009    Simon.Kim@uhhospitals.org   
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Carvell Nguyen, MD, PhD    216-778-4391    cnguyen4@metrohealth.org   
United States, Texas
University of Texas Medical Branch at Galveston Not yet recruiting
Galveston, Texas, United States, 77555
Contact: Stephen B Williams, MD    409-772-2091    stbwilli@UTMB.edu   
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Simon P Kim, MD, MPH University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03157947     History of Changes
Other Study ID Numbers: CASE1817
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

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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 Case Comprehensive Cancer Center:
decision aid
focus group

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases