|Home | About | Journals | Submit | Contact Us | Français|
Disparities in access to cancer care and in outcomes of cancer treatment have long been recognized, evidenced by higher rates of cancer-related deaths among minority populations. Disparities in clinical trials research also exist, with under-representation of individuals of various ethnic backgrounds, older individuals, and residents of low-income neighborhoods and rural areas. Patient navigation programs have been instrumental in increasing access to care for minority populations, and a modification of this concept may help enhance clinical trial participation.participation.
The patient navigation model was created in 1990 by Harold Freeman, MD, who was concerned by the high mortality rates associated with breast cancer in the neighborhood serviced by the Harlem Hospital Center in New York City.1 Freeman noticed that the high rates were attributable to advanced stage of disease at the time of diagnosis. After implementing the use of patient navigators and expanding access to screening, he found a significant decrease in late-stage disease and a significant increase in early detection.2 A similar program at a large urban hospital led to a significant decrease in the rate of missed appointments for colonoscopy screening.3 The patient navigator program continues today at the Ralph Lauren Center for Cancer Care and Prevention where Freeman is the director, and his program has served as the model for the Patient Navigator Outreach and Chronic Disease Prevention Act, which was signed into law in June 2005.
“Patient navigation connects individuals to real people rather than systems or buildings,” says Freeman. “Person-to-person contact is essential.” He adds that patient navigation is offered at two levels: outreach in the community and at the point of diagnosis. Navigators in the community identify, anticipate, and help alleviate barriers that patients encounter in obtaining screening (offered free) and in keeping appointments if results of screening are suspicious.4 Navigators within the hospital setting help patients to overcome logistical, financial, cultural, educational, emotional, and communication barriers. “A critical element of a navigator program is to remove barriers to treatment, because the best chance for cure relies on timely, high-quality treatment,” says Freeman. Navigators help patients to understand treatment options, arrange for interpreters, gain access to treatment drugs, provide referrals to social workers and psychosocial services, and complete the necessary paperwork.
Can the same type of program be used to help enhance clinical trial participation? “It's a logical transition to use navigators for clinical trial research because you have some of the same challenges. First you have to get patients to understand clinical trials as an option for treatment, and then you have to make sure patients adhere to all the requirements of a trial. Navigators can help in both areas,” says Freeman. Others agree that a patient navigator program can be an effective strategy for enhancing participation among populations typically under-represented in cancer clinical trials (see page 243).
The older population has been under-represented in clinical trials because of barriers perceived by both physicians and patients. A recent study was designed to enable better understanding of older patients' perceptions of barriers to participating in a clinical trial. A survey was conducted of more than 200 older patients with cancer (65 to 89 years old) who were recruited from private medical oncology offices affiliated with the University of Colorado Comprehensive Cancer Center and H. Lee Moffitt Cancer Center clinical research networks. Of the respondents, 62% noted at least one barrier, and the most commonly reported barrier was difficulty getting to the university to participate in the trial.5 “The patients also expressed an unwillingness to be treated at the university and leave their own oncologists in the community,” says Michele Basche, MD, of US Oncology, who presented the findings of the study at the 2005 ASCO Annual Meeting. “This highlights the importance of offering trials in community practices,” she adds.
Basche and colleagues are now conducting a second study to evaluate the role of a clinical research navigator in accrual of older patients to trials. Patients in the study will be randomly assigned to one of two groups: one group will receive the National Cancer Institute (NCI) videotape of information about clinical trials, and the other group will have access to a clinical research navigator. Logistic and knowledge-based barriers are the focus of the study, as they were the most commonly reported barriers in the first study.
“The navigator will meet with patients and their families, if they wish, and assess barriers,” explains Basche. “Once the navigator identifies a barrier, the patient will be offered an appropriate intervention. For example, if transportation is a problem, the patient can get a cab voucher. If housing is a problem, the navigator will arrange for a social worker to talk to the patient. If the barrier is knowledge-based, the navigator will help clarify information, address concerns, and even offer to have the patient talk with another patient who is participating in a trial.“ The end point is the proportion of patients in each group who subsequently enroll in the trial.
The study, which is halfway to its accrual goal, is being carried out at the same two sites as the initial survey, as well as the Rocky Mountain Cancer Center, where Basche is the subinvestigator. “We added the Rocky Mountain office to include a community-based setting,“ she says.
Other research on patient navigator programs for cancer care is ongoing, and the 2005 Patient Navigator Outreach and Chronic Disease Prevention Act is providing funding to support such research. The NCI Center to Reduce Cancer Health Disparities is distributing $25 million in grants through its Patient Navigator Research Program, which is designed to evaluate interventions to improve access to timely and appropriate care for patients with breast, cervical, prostate, or colorectal cancer. The research populations include patients from racial/ethnic minority groups, patients with low socioeconomic status, and patients from underserved areas. Eight institutions have been awarded a grant:
Recognizing the need for research in cancer care disparities, ASCO is supporting research in the field by funding a Young Investigator Award (YIA). The Board of Directors approved the support, which was proposed by the ASCO Advisory Group on Health Disparities, led by Co-Chairs Edith Perez, MD, of Mayo Clinic, and Derek Raghavan, MD, PhD, of Cleveland Clinic. The YIA is one of many initiatives the Advisory Group is working on to increase the level of focus within ASCO on disparities in cancer care, including participation in clinical trials. The ASCO Foundation also raised funds to support a Career Development Award (CDA) for research in cancer care disparities. The 2007 Career Development Award (CDA) in Health Disparities in Breast Cancer and Related Cancers will be funded by The Breast Cancer Research Foundation (www.bcrfcure.org).
“There are significant issues that make it difficult to optimize the recruitment of minority populations into clinical trials, including cultural issues, fiscal constraints, problems of access, language barriers, and long-standing suspicion regarding risk exposure and the ethics of trials,” says Raghavan. “The Advisory Group is attempting to tackle some of these items at several levels.” The Group is exploring such initiatives as educational symposia; advocacy for increased funding for cancer care disparities; recruitment programs for minority physicians to enter the field of oncology; and collaboration with other professional societies to provide broader training, education, and research funding opportunities. Raghavan notes, “It is our hope that multiple targeted approaches will culminate in the improved provision of cancer services for underserved populations and an improved understanding and resolution of the issues that contribute to disparities of care.”
The ASCO Foundation provides two grant opportunities for early career investigators interested in the field of health care disparities. The Young Investigator Award provides funding in the amount of $50,000 for 1-year to final-year fellows or first-year junior faculty.
The Clinical Research Career Development Award provides funding in the amount of $200,000 over 3 years to clinical investigators in the second, third, or fourth year of a faculty appointment.
Application deadline: November 8, 2006
More information about the ASCO Foundation Grants Program is available on www.asco.org.