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Prostate Cancer Symptom Management for Low Literacy Men

Phase 2
18 Years
Open (Enrolling)
Localized Prostate Cancer

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Trial Information

Prostate Cancer Symptom Management for Low Literacy Men

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Sexual Bother score from Expanded Prostate Cancer Index Urinary Bother score from Expanded Prostate Cancer Index

Outcome Time Frame:

Six months post-baseline

Safety Issue:


Principal Investigator

David M Latini, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

May 2009

Completion Date:

December 2012

Related Keywords:

  • Localized Prostate Cancer
  • prostate neoplasms
  • Prostatic Neoplasms



Baylor College of Medicine Houston, Texas  77030