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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01447186
First received: October 3, 2011
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention
Prostate Cancer
Cancer
Behavioral: Post-Test Questionnaire
Behavioral: Interviews
Behavioral: Focus Groups

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adaptation of the American Cancer Society (ACS) Early Detection of Prostate Cancer Patient Decision Aid for Spanish Speaking Men

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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: 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.

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447186

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Robert Volk, PHD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01447186     History of Changes
Other Study ID Numbers: 2011-0747
Study First Received: October 3, 2011
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Prostate cancer screening
Prostate Cancer
Patient Decision Aid
Spanish Speaking Men
Spanish-language slide set
Focus group
Interview
Survey

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014