Congress Abstracts 2005

219

CLINICAL TRIALS AND THE ELDERLY: AN EVIDENCED-BASED PROTOCOL. Judith Payne, PhD, RN, AOCN^®, Duke University School of Nursing, Durham, NC.

Patients who are 65 years of age or older are the fastest growing segment of the US population. As the number of older Americans continues to grow, the prevalence of cancer in that population will also increase. While the need for more research on cancer in the older population is apparent, few older patients are being offered information or enrolled in clinical research trials.

The purpose of this presentation is to identify and examine reasons why older persons with cancer are not engaged in clinical research trials, and present an evidenced-based protocol to encourage practice that includes older persons in clinical trial participation. Specific aims are: (1) identify numbers and indicators of older patients with cancer who are eligible for clinical trials but are not enrolled, (2) examine reasons for not participating, (3) explore patients’ and healthcare providers’ perceptions of existing barriers, and (4) examine an evidenced-based protocol for optimal participation in research. Concepts central to evidenced-based practice theory provided a guiding framework for the project.

An evidenced-based protocol for screening, recruiting and enrolling older patients with cancer in clinical research trials.

Indicators used to evaluate the project included a literature review and an assessment of whether and to what extent knowledge and practice changed after the evidenced-based protocol was developed and utilized. The anticipated outcome was an evidenced-based protocol, useful as a guideline for clinicians to engage older persons with cancer in clinical research trials. Outcome indicators included whether there was an increase in the number of older persons with cancer offered information as well as an increase in the number enrolled in clinical trials.

Nurses are key to educating healthcare providers, patients, and the public to increase awareness of the lack of research occurring in the older cancer population. Implications include changing the mindset of clinicians who are reluctant to offer research trials to older patients for reasons that are not supported by the literature or evidenced based, and to provide current, state-of-the art care. Research suggests that clinical trials provide better care, including comprehensive follow-up surveillance. An evidenced-based protocol will help healthcare providers by offering guidelines for use when presenting the option of clinical trial participation to the elderly when study criteria are appropriate.