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

This study is currently recruiting participants.
Verified March 2013 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01447186
First received: October 3, 2011
Last updated: March 21, 2013
Last verified: March 2013

October 3, 2011
March 21, 2013
September 2012
September 2015   (final data collection date for primary outcome measure)
Develop and Evaluate Spanish-Language Slide Set for Group Settings [ Time Frame: At Completion of Focus Group, Questionnaire, and Interview - 1 1/2 hours ] [ Designated as safety issue: No ]
For the evaluation aim of this study a Paired T-Test will be used before and after intervention measures of knowledge.
Same as current
Complete list of historical versions of study NCT01447186 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Adaptation of the American Cancer Society (ACS) Early Detection of Prostate Cancer Patient Decision Aid for Spanish Speaking Men
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).

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Not Provided
Non-Probability Sample

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.

  • Prostate Cancer
  • Cancer
  • Behavioral: Post-Test Questionnaire
    Questionnaire following Demographic questionnaire, Pre-Test Knowledge Questionnaire and slide set review.
    Other Name: 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.
Patient Decision Aid for Spanish Speaking Men
Spanish-Language Slide Set
Interventions:
  • Behavioral: Post-Test Questionnaire
  • Behavioral: Interviews
  • Behavioral: Focus Groups
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Not Provided
September 2015   (final data collection date for primary outcome measure)

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.
Male
45 Years and older
Yes
Contact: Robert Volk, PHD 713-745-4516
United States
 
NCT01447186
2011-0747
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Department of Defense
Principal Investigator: Robert Volk, PHD UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP