Culturally Tailored Decision Aid for Hispanic Patients Diagnosed With Prostate Cancer

NCT03157947 | Withdrawn

• 1 other identifier: CASE1817
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer

Keywords

decision aid; focus group

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Quality of Life in low-income Hispanic/Latino patients diagnosed with localized prostate cancer

  Up to 12 months

Study Arms (1)

Decision Aid

EXPERIMENTAL

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; Behavioral: baseline survey; Behavioral: follow-up surveys

Interventions

Decision Aid Tool BEHAVIORAL

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.

Decision Aid

baseline survey BEHAVIORAL

patients will be given baseline surveys to gather demographic information and readiness to make a decision regarding prostate cancer care

Decision Aid

follow-up surveys BEHAVIORAL

at 3, 6, 9, and 12 months patients will be given follow-up surveys regarding prostate cancer care

Decision Aid

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Simon P Kim, MD, MPH

  University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 17, 2017
• Study Start: August 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07