Clinical trial NCT00769431: 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
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2008-10-09
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Acceptability of the written patient educational materials, in terms of text size, white space, font, and graphics
timeFrame: Single timepoint
measure: Formative evaluation of the new educational materials, in terms of the comments made by the focus group participants
timeFrame: Single timepoint
measure: Validation that the goals of the educational-intervention instruction are being achieved
timeFrame: Single timepoint
measure: Improvement of the educational-intervention instruction by identification and remediation of problems
timeFrame: Single timepoint
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Dan L. Duncan Cancer Center at Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Veterans Affairs Medical Center - Houston
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: David M. Latini, PhD
role: PRINCIPAL_INVESTIGATOR
References: