Culturally Tailored Decision Aid for Hispanic Patients Diagnosed With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03157947
• Other study ID #: CASE1817
• Status: Withdrawn
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: December 2019

Study information

• Verified date: July 2019
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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