Evaluating Symptom Management Educational Materials for Patients With Prostate Cancer

July 24, 2013 updated by: David Latini, Baylor College of Medicine

FOCUS GROUP EVALUATION OF PROSTATE CANCER SYMPTOM MANAGEMENT EDUCATION MATERIALS

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Veterans Affairs Medical Center - Houston
      • Houston, Texas, United States, 77030
        • Dan L. Duncan Cancer Center at Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Focus group
Other: educational intervention
Other: study of socioeconomic and demographic variables

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Investigators

  • Principal Investigator: David M. Latini, PhD, Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

October 8, 2008

First Submitted That Met QC Criteria

October 8, 2008

First Posted (Estimate)

October 9, 2008

Study Record Updates

Last Update Posted (Estimate)

July 26, 2013

Last Update Submitted That Met QC Criteria

July 24, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000600594
  • BCM-H-21622

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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