Culturally Tailored Decision Aid for Hispanic Patients Diagnosed With Prostate Cancer

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Decision Aid Tool; Behavioral: baseline survey; Behavioral: follow-up surveys

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 12 months
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	Up to 12 months
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	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 12 months

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Simon P Kim, MD, MPH, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2017
• Primary Completion (ANTICIPATED): June 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (ACTUAL): May 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: decision aid; focus group
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CASE1817

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No