跳至主要内容
临床试验/NCT00983710
NCT00983710已完成2 期

Prostate Cancer Symptom Management for Low Literacy Men

Baylor College of Medicine2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2009年5月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
108
试验地点
2
主要终点
Sexual Bother score from Expanded Prostate Cancer Index Urinary Bother score from Expanded Prostate Cancer Index

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

  • Younger than 18
  • Diagnosis of advanced prostate cancer
  • No treatment for prostate cancer
  • Diagnosed with localized disease more than 2 years before trial enrollment
  • Unable to speak and understand English
  • Unable to provide informed consent

研究组 & 干预措施

1

Experimental

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.

干预措施: PC-PEP - Prostate Cancer Patient Education Program (Behavioral)

2

Active Comparator

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.

干预措施: Usual care (Behavioral)

结局指标

主要结局

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

时间窗: Six months post-baseline

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Latini

Associate Professor of Urology

Baylor College of Medicine

研究点 (2)

Loading locations...

相似试验