Skip to main content
OpenTrials
Completed

NCT Number: NCT01447186

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

45 year and older

Sex eligibility

Male

Study type

Observational

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male 45 years of age or older.
  • Ethnicity is Hispanic.
  • Language spoken is Spanish.

Exclusion criteria

  • Personal history of prostate cancer.
  • Active military personnel.

Treatment and study plan

Post-Test Questionnaire

Behavioral

Questionnaire following Demographic questionnaire, Pre-Test Knowledge Questionnaire and slide set review.

Other names: Surveys

Interviews

Behavioral

Using draft slide set, participants engage in think-aloud exercises, where each slide is reviewed and described.

Focus Groups

Behavioral

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • United States Department of Defense

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 6, 2011
Registry last updated
Mar 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.