Culturally Tailored Decision Aid for Hispanic Patients Diagnosed With Prostate Cancer
NCT ID: NCT03157947
Last Updated: 2019-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2017-08-01
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
baseline survey
patients will be given baseline surveys to gather demographic information and readiness to make a decision regarding prostate cancer care
follow-up surveys
at 3, 6, 9, and 12 months patients will be given follow-up surveys regarding prostate cancer care
Interventions
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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.
baseline survey
patients will be given baseline surveys to gather demographic information and readiness to make a decision regarding prostate cancer care
follow-up surveys
at 3, 6, 9, and 12 months patients will be given follow-up surveys regarding prostate cancer care
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Simon P Kim, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Other Identifiers
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CASE1817
Identifier Type: -
Identifier Source: org_study_id
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