Culturally Tailored Decision Aid for Hispanic Patients Diagnosed With Prostate Cancer

Not Applicable

Withdrawn

• Conditions: Prostate Cancer

• Registration Number: NCT03157947
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2017-05-16
• Study First Submitted QC: 2017-05-16
• Study First Posted: 2017-05-17
• Study Start: 2017-08-01
• Primary Completion: 2019-06
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-01
• Last Update Posted: 2019-07-05
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Patient satisfaction in low-income Hispanic/Latino patients diagnosed with localized prostate cancer	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	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	Up to 12 months	Prostate cancer knowledge will be measured by the Knowledge Measurement Tool

Secondary Outcome Measures

Name	Time	Method
Quality of Life in low-income Hispanic/Latino patients diagnosed with localized prostate cancer	Up to 12 months	Health-related quality of life will be measured by the EPIC (Expanded Prostate Cancer Index Composite) assessment tool