Cancer clinical trials provide access to the latest cancer treatments available and have been described as providing the best cancer treatments available. However, only about 3% of all cancer patients go on clinical trials. The percentages are even lower among minorities, people of lower socioeconomic status, and the elderly. Major barriers to enrollment come from: patients (e.g., negative perceptions of and/or attitudes toward trials, added treatment costs), physicians (e.g., concerns about the time/effort associated with enrolling patients, discomfort with offering trials), and institutional subunits (e.g., poor communication about clinical trial eligibility, failure to provide support for enrolling patients on trials). However, none of these barriers, by themselves, provides a sufficient explanation for why under-enrollment occurs. We have learned from our previous decade of research that the majority of patients accept enrollment into trials if their oncologists offer and recommend trials to them. The goal of this study is to develop a systems-based intervention to increase the numbers of offers made to patients in order to increase the number of patients enrolling onto trial protocols. Previous research by this team has examined the communication and convergence problems occurring between patients and physicians;this project is focused on directly examining the convergence problems leading to poor enrollment that are due to low integration between physicians and institutional subunits, specifically, the Clinical Trials Offices, at cancer centers. We propose to test the feasibility and efficacy of a two- component intervention that will, at the systems level, 1) increase the integration level between the Clinical Trials Office (CTO) staff and physicians about the availability of clinical trials and patient eligibility criteria for these trials and 2) provide greater support for physicians to ease their added clinical burden in presenting and enrolling patients onto trials. We will use informatics to improve communication between the clinical trial office and physicians regarding trial availability and eligibility criteria, and clinical trials research nurses to improve information flow and communication between and among patients, physicians, and clinical trials office staff regarding enrollment in trials and subsequent patient acceptance of trial protocols. We will evaluate the individual and cumulative impact of the phases of the intervention.
This pilot research examines aspects of a clinical level intervention to increase offers of enrollment into cancer clinical trials to a racially/ethnically diverse patient population at an urban cancer center. The goal is to test the effectiveness of strategies that increase the amount and distribution of information about available clinical trials and patient eligibility among providers and healthcare staff in increasing rates of trial offers to patients. We anticipate our work to have a profound impact on the process and quality of clinical trial offers made to patients, the rates of clinical trial acceptance and enrollment and the advancement of cancer prevention and treatment research.
