Prostate Cancer Symptom Management for Low Literacy Men
|ClinicalTrials.gov Identifier: NCT00983710|
Recruitment Status : Completed
First Posted : September 24, 2009
Last Update Posted : January 23, 2018
|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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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:
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.
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||108 participants|
|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|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||December 2017|
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
- Sexual Bother score from Expanded Prostate Cancer Index Urinary Bother score from Expanded Prostate Cancer Index [ Time Frame: Six months post-baseline ]
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|
|Principal Investigator:||David M Latini, PhD||Baylor College of Medicine|