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Clinical Trials/NCT03157947
NCT03157947
Withdrawn
Not Applicable

Development and Testing of a Culturally Tailored Decision Aid for Hispanic Patients Diagnosed With Prostate Cancer

ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Case Comprehensive Cancer Center
Primary Endpoint
Patient satisfaction in low-income Hispanic/Latino patients diagnosed with localized prostate cancer
Status
Withdrawn
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2017
End Date
December 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

  • Quality of Life in low-income Hispanic/Latino patients diagnosed with localized prostate cancer(Up to 12 months)

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