Adaptation of the American Cancer Society (ACS) Early Detection of Prostate Cancer Patient Decision Aid for Spanish Speaking Men

March 8, 2018 updated by: M.D. Anderson Cancer Center

Objectives:

The primary objective of this project is to develop and evaluate a Spanish-language slide set for administration in group settings, adapted from the content of the current guidelines and existing, self-administered ACS early detection decision aid.

A guide for educators will accompany the slide set so that materials may be distributed on a broad scale at the completion of the project. It is expected that these products will be made available to community-based educators and screening programs to be used in support of an IDM process for early detection of prostate cancer with Spanish-speaking men.

Specific Aims:

To conduct an extensive review of the literature and other resources to identify themes related to early detection, concerns and beliefs about prostate cancer in Hispanic men. Findings will be used to adapt the slideset.

To cognitive test the Spanish-language decision aid slide set with Hispanic men To conduct focus groups to evaluate the acceptability of the adapted slide set with Spanish-speaking Hispanic men who are candidates for prostate cancer screening. Participants will be tested for their knowledge of prostate cancer and acceptability of materials (e.g. length, clarity, amount and balance of information provided).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cognitive Testing Interviews:

If you agree to take part in this study, you will complete a questionnaire about your demographics (age, race, country of origin), education and family history of prostate cancer. This questionnaire should take about 5 minutes to complete.

Then you will take part in a one on one interview with a bilingual member of the study staff. You will be shown draft versions of a slide show about prostate cancer screening. You will then be asked to describe the information in the slides in your own words. You will also be asked about how easy or hard the information is to understand. The interview should last about 1 hour.

Length of Study:

Answering the questionnaire and participating in the interview will take about 1 to 1½ hours of your time. Your participation in this study will be over when the interview is complete.

Evaluation Focus Groups:

If you agree to take part in this study, you will complete 2 questionnaires about your demographics (age, race, country of origin), education, family history of prostate cancer, and knowledge of prostate cancer and its screening. These questionnaires should take about 10 minutes to complete. After the questionnaires, you will take part in a focus group with other men and members of the study.

In the focus group, a bilingual study staff member will lead the discussion by showing the group slides about prostate cancer screening. A doctor or healthcare professional designee will be available to answer questions about prostate cancer screening.

After viewing the slides, you will complete another questionnaire about what you know about prostate cancer. It will also ask what you thought about the information in the slides.

Length of Study:

Answering the questionnaires and participating in the focus group will take about 1 to 1½ hours of your time. Your participation in this study will be over when the focus group session is complete.

This is an investigational study.

Up to 60 participants will take part in this multicenter study. Up to 10 will be enrolled at MD Anderson.

Study Type

Observational

Enrollment (Actual)

4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

The target population is Spanish-speaking Hispanic males, over 45 who have no personal history of prostate cancer who are or will soon be candidates for screening.

Description

Inclusion Criteria:

  1. Male 45 years of age or older.
  2. Ethnicity is Hispanic.
  3. Language spoken is Spanish.

Exclusion Criteria:

  1. Personal history of prostate cancer.
  2. Active military personnel.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient Decision Aid for Spanish Speaking Men
Spanish-Language Slide Set
Behavioral: Post-Test Questionnaire
Questionnaire following Demographic questionnaire, Pre-Test Knowledge Questionnaire and slide set review.
Other Names:
  • Surveys
Behavioral: Interviews
Using draft slide set, participants engage in think-aloud exercises, where each slide is reviewed and described.
Behavioral: Focus Groups
Up to 40 subjects will participate in the formative focus groups. Each group will be scheduled with 6 to 10 participants to explore Hispanic men's beliefs and concerns about prostate cancer and early detection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Develop and Evaluate Spanish-Language Slide Set for Group Settings
Time Frame: At Completion of Focus Group, Questionnaire, and Interview - 1 1/2 hours
For the evaluation aim of this study a Paired T-Test will be used before and after intervention measures of knowledge.
At Completion of Focus Group, Questionnaire, and Interview - 1 1/2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Robert Volk, PHD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2012

Primary Completion (Actual)

January 13, 2015

Study Completion (Actual)

January 13, 2015

Study Registration Dates

First Submitted

October 3, 2011

First Submitted That Met QC Criteria

October 4, 2011

First Posted (Estimate)

October 6, 2011

Study Record Updates

Last Update Posted (Actual)

March 12, 2018

Last Update Submitted That Met QC Criteria

March 8, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-0747
  • 11095006 (Other Grant/Funding Number: Department of Defense)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Clinical Trials on Post-Test Questionnaire

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe