Evaluating Symptom Management Educational Materials for Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

FOCUS GROUP EVALUATION OF PROSTATE CANCER SYMPTOM MANAGEMENT EDUCATION MATERIALS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00769431
• Other study ID #: CDR0000600594
• Secondary ID: BCM-H-21622
• Status: Completed
• Phase: N/A
• First received: October 8, 2008
• Last updated: July 24, 2013
• Start date: May 2008
• Est. completion date: July 2009

Study information

• Verified date: July 2013
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Collecting feedback from patients with prostate cancer may help doctors develop better symptom management educational materials for patients.

PURPOSE: This clinical trial is evaluating symptom management educational materials for patients with prostate cancer.

Description:

OBJECTIVES:

• To collect formative evaluation data about a new educational intervention using focus groups of patients with prostate cancer.

• To use the focus group data in the master's research paper of a Baylor College of Medicine physician-assistant student who is documenting the process of organizing and conducting the focus groups, enumerating areas where the new materials are deemed problematic, and identifying themes in the comments made by the focus group participants.

OUTLINE: Study participants are assigned to 1 of 3 focus groups according to educational level and ethnicity (i.e., lower educational-level African-American men primarily from the Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC); lower educational-level Caucasian men from MEDVAMC, Baylor College of Medicine (BCM), or the community; or higher educational-level Caucasian men primarily from BCM or the community).

Participants review written patient educational-intervention materials on prostate cancer and provide feedback to the investigator on the content and acceptability of these materials during a 1½-2-hour focus group discussion. Feedback data are used to revise the intervention materials so that they are appropriate to the target population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Biopsy-proven prostate cancer

• Localized disease that has been previously treated

• Selected for participation from 1 of the following:

• Convenience sample of men from the Baylor College of Medicine (BCM) Urology clinics at Scurlock Tower (including the Urology clinic at MEDVAMC) and local prostate cancer-support groups

• Prostate cancer survivors who participated in the US TOO Father's Day Walk/Run or the Gay Pride Celebration

PATIENT CHARACTERISTICS:

• Able to speak and read in English

• Willing to review the written patient educational materials and discuss them in a group setting

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• educational intervention

• study of socioeconomic and demographic variables

Locations

Country	Name	City	State
United States	Dan L. Duncan Cancer Center at Baylor College of Medicine	Houston	Texas
United States	Veterans Affairs Medical Center - Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of the written patient educational materials, in terms of text size, white space, font, and graphics		Single timepoint	No
Primary	Formative evaluation of the new educational materials, in terms of the comments made by the focus group participants		Single timepoint	No
Primary	Validation that the goals of the educational-intervention instruction are being achieved		Single timepoint	No
Primary	Improvement of the educational-intervention instruction by identification and remediation of problems		Single timepoint	No