Clinical trial NCT03157947: Culturally Tailored Decision Aid for Hispanic Patients Diagnosed With Prostate Cancer
Official title: Development and Testing of a Culturally Tailored Decision Aid for Hispanic Patients Diagnosed With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Cancer
Keywords: decision aid
focus group
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Decision Quality of cancer care in low-income Hispanic/Latino patients diagnosed with localized prostate cancer
timeFrame: Up to 12 months
measure: Knowledge of prostate cancer care in low-income Hispanic/Latino patients diagnosed with localized prostate cancer
timeFrame: Up to 12 months
measure: Patient satisfaction in low-income Hispanic/Latino patients diagnosed with localized prostate cancer
timeFrame: Up to 12 months
Secondary outcomes:
measure: Quality of Life in low-income Hispanic/Latino patients diagnosed with localized prostate cancer
timeFrame: Up to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Simon P Kim, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: