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Prostate Cancer Symptom Management for Low Literacy Men

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ClinicalTrials.gov Identifier: NCT00983710
Recruitment Status : Active, not recruiting
First Posted : September 24, 2009
Last Update Posted : November 9, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Behavioral: PC-PEP - Prostate Cancer Patient Education Program Behavioral: Usual care Phase 2

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Detailed Description:

Prostate cancer has recently surpassed lung cancer to become the most common cancer of American men. The estimated number of new prostate cancer cases in 2005 is expected to be 232,090, up from 198,000 in 2002. Prostate cancer represents 29% of all new cancer diagnoses in men and is comparable to the incidence of breast cancer in women. Prostate cancer continues to disproportionately affect minority men. For patients with early, localized prostate cancer, there are a number of treatment options, including surgical removal of the prostate, radiation therapy (external beam or implantation of radioactive "seeds"), hormonal therapy, cryoablation, or expectant monitoring ("watchful waiting"). Most of these currently available treatments for localized prostate cancer carry the risk of a number of iatrogenic symptoms, including urinary incontinence, ED, and others that vary depending on the treatment received.

The need for symptom management education is greater for men with lower health literacy. Health literacy - "the ability to which individuals have the capacity to obtain, process, and understand health information services needed to make appropriate health decisions" - has been shown to be strongly related to health status and health outcomes. Persons with lower health literacy skills are significantly less likely to take preventive actions to improve their health. Health literacy is a particular concern for men with prostate cancer because African-American men, a group with a significantly higher prevalence of prostate cancer, are over-represented among lower literacy men with prostate cancer.3 The study proposed here will develop and evaluate in a randomized controlled trial (RCT) an empirically-derived symptom management intervention for lower literacy men with prostate cancer. The intervention will be based on a biopsychosocial model of prostate cancer symptom management developed from the more general the UCSF Symptom Management Model (SMM) and Bandura's Self-Efficacy Theory.

The efficacy of the intervention will be evaluated with 200 men with localized prostate cancer randomized to receive either the new tailored symptom management program or usual care. Participants in both the intervention and control groups will receive a booklet on coping with cancer available to all patients treated at the UCSF Comprehensive Cancer Center. Intervention group participants also will receive a new symptom management intervention tailored to their individual symptom profile. Both groups will be followed for 6 months after enrollment, with assessments at enrollment and 5 additional timepoints.

The proposed research project includes the following specific aims:

  1. Conduct an RCT to evaluate a tailored symptom management intervention targeted to lower literacy men with localized prostate cancer.

    The investigators hypothesize men who receive the tailored symptom management intervention (N=100) will report significantly less symptom distress at the 6-month follow-up than men in the control condition (N=100). Symptom distress will be measured by the Expanded Prostate Cancer Index Composite (EPIC) Urinary Bother and Sexual Bother sub-scales. The intervention and control groups will be stratified by literacy level and type of prostate cancer treatment.

  2. Complete a planned training experience that will include courses in responsible conduct of research, symptom management, cancer care, cancer prevention, cancer epidemiology, clinical research with diverse communities, and longitudinal analysis methods that will provide the knowledge and skills necessary to successfully conduct the RCT.
  3. Assemble a group of key personnel with expertise necessary to guide the training experience and RCT. The primary mentor will be Leslie Schover, PhD, an expert in cancer symptom management. Other key personnel will include Stephen J. Lepore, PhD, Principal Investigator of a previous prostate cancer psychosocial intervention study; Brian J. Miles, MD, an expert in prostate cancer treatment; and Robert Morgan, PhD, a senior methodologist.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prostate Cancer Symptom Management for Low Literacy Men
Study Start Date : May 2009
Primary Completion Date : October 2011
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Sexual Bother score from Expanded Prostate Cancer Index Urinary Bother score from Expanded Prostate Cancer Index [ Time Frame: Six months post-baseline ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00983710

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
Principal Investigator: David M Latini, PhD Baylor College of Medicine
More Information

Responsible Party: David Latini, Associate 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
First Posted: September 24, 2009    Key Record Dates
Last Update Posted: November 9, 2016
Last Verified: November 2016

Keywords provided by David Latini, Baylor College of Medicine:
prostate neoplasms

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