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Evaluating Symptom Management Educational Materials for Patients With Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Latini, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00769431
First received: October 8, 2008
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Prostate Cancer
Other: educational intervention
Other: study of socioeconomic and demographic variables

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: FOCUS GROUP EVALUATION OF PROSTATE CANCER SYMPTOM MANAGEMENT EDUCATION MATERIALS

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Acceptability of the written patient educational materials, in terms of text size, white space, font, and graphics [ Time Frame: Single timepoint ] [ Designated as safety issue: No ]
  • Formative evaluation of the new educational materials, in terms of the comments made by the focus group participants [ Time Frame: Single timepoint ] [ Designated as safety issue: No ]
  • Validation that the goals of the educational-intervention instruction are being achieved [ Time Frame: Single timepoint ] [ Designated as safety issue: No ]
  • Improvement of the educational-intervention instruction by identification and remediation of problems [ Time Frame: Single timepoint ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: May 2008
Study Completion Date: July 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Focus group Other: educational intervention Other: study of socioeconomic and demographic variables

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769431

Locations
United States, Texas
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texas, United States, 77030
Veterans Affairs Medical Center - Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: David M. Latini, PhD Baylor College of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: David Latini, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00769431     History of Changes
Other Study ID Numbers: CDR0000600594, BCM-H-21622
Study First Received: October 8, 2008
Last Updated: July 24, 2013
Health Authority: United States: Federal Government

Keywords provided by Baylor College of Medicine:
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 22, 2014