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Wednesday, August 13, 2014

ONLINE FIRST: Study: Breast Cancer Patients Who See a Patient Navigator Are More Likely to Receive Anti-estrogen Therapy



Women with breast cancer who are assigned a patient navigator are more likely to receive anti-estrogen therapy than patients without a navigator, according to the first national, multicenter study to evaluate whether patient navigation can improve the quality of breast cancer care.


“Patient navigation may have a direct benefit on the delivery of quality breast cancer care, particularly among low-income, minority women,” the study’s first author, Naomi Ko, MD, MPH, AM, Instructor of Medicine in the Hematology Oncology & Women's Health Unit at Boston University School of Medicine, said in an interview.


Patient navigation programs have emerged as a potential solution to assist with cancer care delivery for underserved patients. Ko explained that while traditionally, patient navigation targeted the cancer screening process, it has rapidly evolved within oncology practice so that navigators are expected members of oncology teams. Recent studies suggest a benefit of patient navigation within time to diagnosis and follow-up from an abnormal screening.


“Poor and underserved women face barriers in receiving timely and appropriate breast cancer care,” she said. Patient navigators can help these women overcome these barriers, but little is known about whether patient navigation improves quality of care.


For the study, the national Patient Navigation Research Program, the results of which are  now available online ahead of print in the Journal of Clinical Oncology (doi: 10.1200/JCO.2013.53.6037), she and her colleagues set out to examine whether navigated women with breast cancer are more likely to receive recommended standard breast cancer care.


Breast cancer patients were examined to determine whether the care they received included three breast cancer standards of quality care:

  • initiation of anti-estrogen therapy in patients with hormone receptor–positive breast cancer;
  • initiation of post-lumpectomy radiation therapy; and
  • initiation of chemotherapy in women younger than age 70 who had triple-negative tumors more than one cm in size.

Of the 1,004 patients in the study, 761 were eligible for anti-estrogen therapy, 552 were eligible for radiation therapy, and 158 were eligible for chemotherapy (the categories were not mutually exclusive). About half the patients in each of these groups were assigned a patient navigator while the other half received no navigation. More than one-third of the patients were African American and about one-quarter were Hispanic. 


The researchers performed a secondary analysis of a multicenter “quasi-experimental” study funded by the National Cancer Institute to evaluate patient navigation. Multiple logistic regression was performed to compare differences in receipt of care between navigated and non-navigated participants.


A multivariable analysis found that, among participants eligible for anti-estrogen therapy, navigated participants had a statistically significant higher likelihood of receiving anti-estrogen therapy compared with the non-navigated controls. Among the participants eligible for radiation therapy after lumpectomy, navigated participants were no more likely to receive radiation than controls were. Because of the small sample size and limited variation in the receipt of recommended chemotherapy treatment, the value of the addition of a navigator was inconclusive from the data available, the researchers said.


“The results suggest that patient navigation can be a promising solution/intervention, particularly because the current literature suggests that minority women of low socioeconomic status are at risk of low adherence to anti-estrogen therapy.”


“Patient navigation is a promising intervention to help women who have challenges navigating medical care get timely and appropriate care. We still need to understand how and where patient navigation can have its biggest impact,” Ko said.


The researchers noted that questions remain regarding the specific tasks or barriers addressed that may help to facilitate treatment. For example, the navigator tasks could vary by the type of therapy (anti-estrogen treatment, radiation treatment, or chemotherapy) and specific navigator interaction (financial assistance, transportation, or patient education). It is possible, the team said, that patient navigators may have helped with obtaining prescriptions or increasing patient understanding of the benefits of anti-estrogen treatment.


Tool Kit

The Avon Breast Health Initiative at Boston Medical Center research unit has developed a tool kit to help assist in the design and implementation of patient navigation programs. Available in three volumes for three different audiences—program planners, supervisors, and patient navigators, the kit includes case studies, tools, and resources from cancer care navigation that can be applied to reduce the impact of the target disease, health disparities, and barriers to care.


Asked for her opinion about the study, Daleela Dodge, MD, Medical Director of the Breast Service at Lancaster General Health in Pennsylvania, said, “What makes this interesting article unique is the use of the original three criteria developed by the American Cancer Society to compare hospitals as cancer centers. These particular criteria were started in 2005. We now have seven criteria, and as of 2015 this will go up to 12 criteria against which quality metrics can be looked at.”


In 1990, Harold Freeman, MD, established the nation’s first patient navigation program at Harlem Hospital Center in New York City looking to help African American women with breast cancer gain access to health care. “Patient navigation was created for low socioeconomic patients, and has evolved over time to include all women,” Dodge said. “What also makes this paper unique is how many minority patients were included. Historically, this goes back to the beginnings of patient navigation.”


Patient navigators, usually oncology nurses, provide a single point of contact, and act as advocates and personal care coaches, said Dodge, who is the cancer liaison physician for her center for the American College of Surgeons Commission on Cancer (COC).


Remove Barriers, Both Real and Perceived

“The primary role of the navigator is to remove barriers, both real and perceived. Low socioeconomic groups maintain high levels of fear of side effects and feelings about why medicine may not be good for them. When I prescribe tamoxifen, for example, one of the first things patients say to me is ‘I’m not going to take it. I’ve heard bad things about it.’ This is magnified among lower socioeconomic groups. The level of understanding they need is huge, and navigation plays an important role.”


Cultural considerations may also get in the way of successful treatment--for example, a patient who believes she can no longer consider herself a woman if she has breast-removal surgery.


Navigators often have very personal relationships with patients. “Patients will often ask navigators questions they won’t ask me, no matter how open I try to be,” Dodge noted. “The navigator may reframe an issue that I thought I had explained very well, and come back to me with the patient’s questions.


“In addition, each navigator is with the patient most of the time, and is available nearly all the time. The surgeon may be in the operating room and therefore not available to answer questions.”


Navigators may also help fill out the treatment summary required for each patient by the CoC. “The surgeon usually presents cases to the breast cancer tumor board. An efficient, focused navigator can also present cases. That role has morphed from patient advocate to the organizational wheel behind the breast cancer patient program,” Dodge explained.


“We now have five patient navigators--two who work with breast cancer patients and three who work in other areas. Every patient who has cancer deserves navigation.”



She pointed out that patient navigation is an unreimbursed resource by insurers, and is generally not available through an oncology-only practice. Most navigators come into an oncology practice as health care system employees. The vast majority of nurse navigators are not certified. Most of them are nurses coming off oncology wards in an either inpatient or outpatient setting, said Dodge, who added that in most situations clinicians hire good nurses with oncology knowledge to act as navigators.


In an oncology practice, navigators “do not necessarily have to be certified. You just need to fulfill the role of navigator and have the ability to support patients,” she said. “The quality of patient care can improve by the navigator asking some simple early questions—for example: Is the patient getting the consultations she needs? Does she understand enough about the therapy to accept it?”


Dodge noted that her facility is a comprehensive community cancer center, and that as of 2015, CoC guidelines will require a certified nurse navigator for the facility to receive such certification. “Many cancer centers have so many functioning clinical trial nurses that they do not need to put in a specific navigation program,” she noted.

“In our institution, one point of contact for navigators is a Category 0 reading on a mammogram. It may take a week or two to get the patient back into the office to discuss the result, which can be hugely upsetting. We have an imaging nurse navigator call the patient, support her through the biopsy process, and then hand off her off to a breast cancer navigator.”


Dodge noted that one limitation of the Ko et al study is that it did not define navigation, which is used in many different ways from institution to institution. “For example, some programs use navigation exclusively in the initial treatment-planning process, while others provide survivorship navigation, including a new navigator in the post-treatment phase.”


In addition, Dodge said, the study shows a positive impact for navigators in situations when compliance can be low, but long-term outcomes are also important to care: “What percentage of patients got all phases of care? It is not clear cut that the patients had everything done or that they saw all the doctors, who then followed through with care,” she said. “It’s crucial that patients see all subspecialists and receive the care they are supposed to get.


“Breast cancer is hugely complex,” she concluded. “With so many folks in the diagnostic and treatment pathway, navigation becomes even more crucial. In addition, with the Affordable Care Act, the need for navigation will increase since we have so many more people going through the system.”




OT Series

For additional information see OT’s four-part 2012 series about the history, concept, and ongoing status of patient navigation as a key resource for cancer patients: