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Prostate Cancer Symptom Management for Low Literacy Men

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
American Cancer Society, Inc.
Michael Debakey Veterans Affairs Medical Center
Information provided by (Responsible Party):
David Latini, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00983710
First received: September 22, 2009
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  Purpose

This study will compare a newly-developed patient education program to help men with localized prostate cancer manage treatment-related side-effects versus usual care. The new intervention will be developed for men with lower health literacy. That means that the education materials will be developed for sixth grade reading level or lower. The materials will include lots of examples and illustrations to make it easier for people understand the information.


Condition Intervention Phase
Localized Prostate Cancer
 Behavioral: PC-PEP - Prostate Cancer Patient Education Program
Behavioral: Usual care
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Prostate Cancer Symptom Management for Low Literacy Men

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Sexual Bother score from Expanded Prostate Cancer Index Urinary Bother score from Expanded Prostate Cancer Index [ Time Frame: Six months post-baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2009
Estimated Study Completion Date: December 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive a new patient education program designed to help men manage side-effects related to treatment for localized prostate cancer. The intervention will be targeted to low health literacy men.
 Behavioral: PC-PEP - Prostate Cancer Patient Education Program
Men in the intervention group will receive a new patient education intervention to help them manage side-effects related to treatment for localized prostate cancer. The intervention will be delivered by phone and by mail and is targeted to me with low health literacy. The intervention consists of written materials, audio materials, and telephone-based problem-solving education.
Active Comparator: 2
Usual care, including a booklet on coping with localized prostate cancer. After the 6-month primary outcome data are collected, control group men will be offered the opportunity to cross-over and receive the new educational intervention.
 Behavioral: Usual care
Booklet on coping with localized prostate cancer

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male
  2. 18 years or older, with biopsy-proven prostate cancer
  3. Diagnosed with localized disease in the preceding 2 years
  4. Have a telephone at the time of enrollment
  5. Have an address where they can receive intervention materials by mail
  6. Able to speak and understand English
  7. Treated with radiation, surgery, or hormonal therapy
  8. Receive prostate cancer treatment and follow-up at the Michael E DeBakey VA Medical Center in Houston, TX

Exclusion Criteria:

  1. Younger than 18
  2. Female
  3. Diagnosis of advanced prostate cancer
  4. No treatment for prostate cancer
  5. Diagnosed with localized disease more than 2 years before trial enrollment
  6. Unable to speak and understand English
  7. Unable to provide informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00983710

Locations
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
American Cancer Society, Inc.
Michael Debakey Veterans Affairs Medical Center
Investigators
Principal Investigator: David M Latini, PhD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: David Latini, Adjunct Assistant Professor of Urology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00983710     History of Changes
Obsolete Identifiers: NCT00903123, NCT00903487
Other Study ID Numbers: MRSGT-06-083-01-CPPB
Study First Received: September 22, 2009
Last Updated: November 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
prostate neoplasms

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 June 17, 2013