Evaluating Symptom Management Educational Materials for Patients With Prostate Cancer

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Other: educational intervention; Other: study of socioeconomic and demographic variables

• Registration Number: NCT00769431
• Lead Sponsor: Baylor College of Medicine

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-10-08
• Study First Submitted QC: 2008-10-08
• Study First Posted: 2008-10-09
• Primary Completion: 2009-04
• Study Completion: 2009-07
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-24
• Last Update Posted: 2013-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Focus group	educational intervention	-
Focus group	study of socioeconomic and demographic variables	-

Primary Outcome Measures

Name	Time	Method
Acceptability of the written patient educational materials, in terms of text size, white space, font, and graphics	Single timepoint
Formative evaluation of the new educational materials, in terms of the comments made by the focus group participants	Single timepoint
Validation that the goals of the educational-intervention instruction are being achieved	Single timepoint
Improvement of the educational-intervention instruction by identification and remediation of problems	Single timepoint

Trial Locations

Locations (2)

Dan L. Duncan Cancer Center at Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Veterans Affairs Medical Center - Houston; 🇺🇸 Houston, Texas, United States