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Culturally Tailored Decision Aid for Hispanic Patients Diagnosed With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Decision Aid Tool
baseline survey
follow-up surveys
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring decision aid, focus group

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Decision Aid

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Decision Quality of cancer care in low-income Hispanic/Latino patients diagnosed with localized prostate cancer
    Decisional quality will be measured by the O'Connor Decisional Conflict Scale
    Knowledge of prostate cancer care in low-income Hispanic/Latino patients diagnosed with localized prostate cancer
    Prostate cancer knowledge will be measured by the Knowledge Measurement Tool
    Patient satisfaction in low-income Hispanic/Latino patients diagnosed with localized prostate cancer
    Patient satisfaction will be measured by the CAPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor) patient satisfaction measurement tool

    Secondary Outcome Measures

    Quality of Life in low-income Hispanic/Latino patients diagnosed with localized prostate cancer
    Health-related quality of life will be measured by the EPIC (Expanded Prostate Cancer Index Composite) assessment tool

    Full Information

    First Posted
    May 16, 2017
    Last Updated
    July 1, 2019
    Sponsor
    Case Comprehensive Cancer Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03157947
    Brief Title
    Culturally Tailored Decision Aid for Hispanic Patients Diagnosed With Prostate Cancer
    Official Title
    Development and Testing of a Culturally Tailored Decision Aid for Hispanic Patients Diagnosed With Prostate Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study Team did not respond to requests for continuing review approval.
    Study Start Date
    August 1, 2017 (Actual)
    Primary Completion Date
    June 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Case Comprehensive Cancer Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    decision aid, focus group

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Decision Aid
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Decision Aid Tool
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    baseline survey
    Intervention Description
    patients will be given baseline surveys to gather demographic information and readiness to make a decision regarding prostate cancer care
    Intervention Type
    Behavioral
    Intervention Name(s)
    follow-up surveys
    Intervention Description
    at 3, 6, 9, and 12 months patients will be given follow-up surveys regarding prostate cancer care
    Primary Outcome Measure Information:
    Title
    Decision Quality of cancer care in low-income Hispanic/Latino patients diagnosed with localized prostate cancer
    Description
    Decisional quality will be measured by the O'Connor Decisional Conflict Scale
    Time Frame
    Up to 12 months
    Title
    Knowledge of prostate cancer care in low-income Hispanic/Latino patients diagnosed with localized prostate cancer
    Description
    Prostate cancer knowledge will be measured by the Knowledge Measurement Tool
    Time Frame
    Up to 12 months
    Title
    Patient satisfaction in low-income Hispanic/Latino patients diagnosed with localized prostate cancer
    Description
    Patient satisfaction will be measured by the CAPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor) patient satisfaction measurement tool
    Time Frame
    Up to 12 months
    Secondary Outcome Measure Information:
    Title
    Quality of Life in low-income Hispanic/Latino patients diagnosed with localized prostate cancer
    Description
    Health-related quality of life will be measured by the EPIC (Expanded Prostate Cancer Index Composite) assessment tool
    Time Frame
    Up to 12 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Simon P Kim, MD, MPH
    Organizational Affiliation
    University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Culturally Tailored Decision Aid for Hispanic Patients Diagnosed With Prostate Cancer

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