Culturally Tailored Decision Aid for Hispanic Patients Diagnosed With Prostate Cancer

Case Comprehensive Cancer Center (Case CCC)

Status: Withdrawn

Conditions: Prostate Cancer

Treatments: Behavioral: follow-up surveys; Behavioral: baseline survey; Behavioral: Decision Aid Tool

Study type: Interventional

Funder types: Other

Identifiers

NCT03157947

CASE1817

Details and patient eligibility

About

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.

Full 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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Decision Aid

Experimental group

Description:

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.

Treatment:

Behavioral: follow-up surveys

Behavioral: Decision Aid Tool

Behavioral: baseline survey