Evaluating Symptom Management Educational Materials for Patients With Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
educational intervention
study of socioeconomic and demographic variables
Sponsored by
About this trial
This is an interventional health services research trial for Prostate Cancer focused on measuring stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer
Eligibility Criteria
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
Sites / Locations
- Dan L. Duncan Cancer Center at Baylor College of Medicine
- Veterans Affairs Medical Center - Houston
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
Focus group
Arm Description
Outcomes
Primary Outcome Measures
Acceptability of the written patient educational materials, in terms of text size, white space, font, and graphics
Formative evaluation of the new educational materials, in terms of the comments made by the focus group participants
Validation that the goals of the educational-intervention instruction are being achieved
Improvement of the educational-intervention instruction by identification and remediation of problems
Secondary Outcome Measures
Full Information
NCT ID
NCT00769431
First Posted
October 8, 2008
Last Updated
July 24, 2013
Sponsor
Baylor College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00769431
Brief Title
Evaluating Symptom Management Educational Materials for Patients With Prostate Cancer
Official Title
FOCUS GROUP EVALUATION OF PROSTATE CANCER SYMPTOM MANAGEMENT EDUCATION MATERIALS
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Focus group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
educational intervention
Intervention Type
Other
Intervention Name(s)
study of socioeconomic and demographic variables
Primary Outcome Measure Information:
Title
Acceptability of the written patient educational materials, in terms of text size, white space, font, and graphics
Time Frame
Single timepoint
Title
Formative evaluation of the new educational materials, in terms of the comments made by the focus group participants
Time Frame
Single timepoint
Title
Validation that the goals of the educational-intervention instruction are being achieved
Time Frame
Single timepoint
Title
Improvement of the educational-intervention instruction by identification and remediation of problems
Time Frame
Single timepoint
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M. Latini, PhD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dan L. Duncan Cancer Center at Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Veterans Affairs Medical Center - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluating Symptom Management Educational Materials for Patients With Prostate Cancer
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