Adaptation of the American Cancer Society (ACS) Early Detection of Prostate Cancer Patient Decision Aid for Spanish Speaking Men
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01447186|
Recruitment Status : Active, not recruiting
First Posted : October 6, 2011
Last Update Posted : February 19, 2018
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.
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).
|Condition or disease||Intervention/treatment|
|Prostate Cancer Cancer||Behavioral: Post-Test Questionnaire Behavioral: Interviews Behavioral: Focus Groups|
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|
|Estimated Enrollment :||60 participants|
|Official Title:||Adaptation of the American Cancer Society (ACS) Early Detection of Prostate Cancer Patient Decision Aid for Spanish Speaking Men|
|Actual Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2020|
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 Name: SurveysBehavioral: 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01447186
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Robert Volk, PHD||M.D. Anderson Cancer Center|