Is ‘Integrated Oncology’ Effective?

Bastyr University and Fred Hutchinson Cancer Research Center Partner to Find Out

by Leanna J. Standish, ND, PhD; Erin Sweet, ND; Eleonora Naydis, ND, Lac; and Robyn Andersens, PhD

The Bastyr Integrative Oncology Research Center opened in February 2009

The Bastyr Integrative Oncology Research Center (BIORC) was established to evaluate the hypothesis that high quality, science-based integrative oncology services will improve survival, reduce relapse rates and improve health-related quality of life. For Bastyr, integrative oncology means:

• integration of Eastern and Western complementary and alternative medicine (CAM)

• integration of care with surgeons, medical and radiation oncologists.

• licensed integrative oncology providers that include naturopathic physicians, doctors of acupuncture and oriental medicine and nutritionists.

• mind-body medicine that integrates body and breath with mind

BIORC offers patients at all stages of cancer comprehensive care that is integrated with their standard care through cross referrals, shared progress notes, and, in complex cases, true co-management between BIORC providers and the patients MDs. In 2009 the Bastyr Integrative Oncology Research Center obtained IRB (institutional review board) approval to conduct a matched controlled outcomes study in collaboration with Fred Hutchinson Cancer Research Center using a matched controlled cohort prospective outcomes design. We hypothesize that integrative oncology (IO) services improve patients’ quality of life and decrease cancer recurrence rates in cancer patients, as compared with cancer patients with similar disease states and prognoses who do not receive IO care, and may or may not use CAM treatment on their own. A seed grant from Cleavage Creek Cellars made it possible for Bastyr to set up this new outpatient clinic and to support the gathering of data – clinical, laboratory, and quality-of-life outcome data – that is needed to answer the question of whether integrative oncology actually works and works well enough to be worth the additive costs of this care.

BIORC has both clinical and research goals. BIORC’s mission is to provide state-of-the-science IO therapy to all cancer patients and simultaneously to collect prospective clinical outcomes data every year on each BIORC case. BIORC patients have also agreed to participate in the matched controlled outcomes study. IRB approval for BIORC’s outcomes study was obtained from Bastyr University IRB in February 2009 and from Fred Hutchinson Cancer Research Center on 2010. In the first 18 months of BIORC operation, 218 cancer patients at all stages of disease were consented and enrolled. Willingness to participate as a study participant is a requirement for receiving care at BIORC, and 98% of patients have consented to participate at intake.

Integrative Oncology Clinics Are Significant Providers of CAM Care in Washington State.

Physician-level CAM and IO is evidence based, and “best practices” have arisen in the field of integrative oncology. Each of the IO treatment commonly used are designed to influence some aspect of tumor inhibition including anti-inflammatory, immunomodulatory, antiangiogenic, or antimetastatic activity (see Standish et al. 2002, 2007, 2009 for doses, rationale, and literature review).

Western Washington Is Home to Four Integrative Oncology Clinics

There are four integrative oncology clinics in the Seattle area that are led by naturopathic physicians with advanced training in naturopathic oncology and a board certified Fellows of the American Board of Naturopathic Oncology (FABNO). Seattle Cancer Treatment & Wellness Center in Renton, Tahoma Clinic in Kent, Providence Integrative Cancer Care in Lacey, and BIORC in Kenmore each year provide care to hundreds of cancer patients who seek science-based IO care. The core CAM approaches used in these four large IO clinics in western Washington are evidence-based and similar. Together these integrative oncology outpatient clinics provide care for hundreds of cancer patients living in the Seattle area, including acupuncture, nutraceutical therapy, dietary, and botanical therapy, as well as physical and psychological rehabilitation after primary cancer treatment.

There Are Testable Hypotheses Regarding the Value of the Additive Expenses of Integrated Oncology Care

An empirical test of current IO principles and practices (see Society of Integrative Oncology for information on current research and training in IO) is warranted. We must not confuse the potential benefits of IO physician-level medical service with the potential harm of self-prescribed CAM use. As CAM physician-level services are generally considered an additive cost, it is important to know whether they improve outcomes of standard care. There are several mechanisms by which IO might be effective. IO is likely to assist patients in completing all chemotherapy and radiation cycles and without delay by safely mitigating side effects such neutropenias, anemias, intolerable nausea, neuropathy, mucositis, and third-degree thoracic skin burns. IO immunologic and antiangiogenic therapies may delay recurrence of cancer following primary treatment. IO palliative care may assist patients with advanced cancer to survive longer with higher quality of life.

Seattle and Western Washington State Are the Ideal Setting for the First Prospective IO Cancer Outcomes Study

We have selected breast cancer as the first matched controlled prospective outcomes study because breast cancer is highly prevalent in Seattle and many women with breast cancer seek out IO services. Bastyr University’s research mission has been to focus on public health issues of concern. The Seattle area is an ideal location for the first matched controlled study of IO for two reasons.

First, there are three active IO clinics in the Seattle area from which to recruit subjects for a matched controlled outcomes study. Second, in Washington State, medical insurance companies are required to cover the services of all licensed CAM providers, including NDs, LAcs, and DAOMs. Since 2006, NDs in IO clinics are expected to be nationally board-certified in naturopathic oncology, a leading edge in the field of IO. Since office consultations and medical procedures by licensed naturopathic physicians, licensed doctors of Oriental medicine, licensed acupuncturists, and licensed massage therapists are reimbursable services in the state of Washington, the evaluation of this service on clinical outcomes is both feasible and warranted.

Second, Seattle is home to four IO clinics that have been providing “best practice” IO care to cancer patients for years. Seattle medical and radiation oncologists refer their cancer patients to these three IO clinics, which together provide the cancer population from which we will recruit. These three Seattle clinics are widely recognized by both the conventional and CAM medical communities for providing best-practice integrative oncology that includes board-certified NDs, DAOMS, and LAcs with an oncology specialty that is integrated with, and appropriate to, standard cancer treatment.

In Washington State Medical Insurance Companies Pay for IO

Approximately 75% of BIORC’s patients’ care is covered by their medical insurance. Most of the remaining 25% are patients 65 years and older whose primary medical insurance is Medicare, which thus far has not covered the care of licensed CAM providers anywhere in the US. The fact that clinic visits and procedures are covered by many of IO patients in Washington State makes the Seattle area in western Washington the ideal setting to conduct a prospective outcomes study. Federal grants will cover the cost of the research but not the cost of clinical care offered by IO clinics.

Why a Health–Services Matched Controlled Prospective Outcomes Study of Cancer IO Is the Best Research Strategy

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Not a Randomized Controlled Clinical Trial

As a first step in the evaluation of integrative oncology as practiced in the community in a real-world setting, it is appropriate to take a health services research orientation. The long-term goal of the proposed program of research is to evaluate the health outcomes of women who receive physician-level IO care and services. It is not our intention to evaluate the safety or efficacy of specific individual or specific combinations of natural medicines. Rather, we are asking if exposure to IO medical services from four IO clinics, well respected in both the CAM and conventional oncology communities, influences HRQOL (health-related quality of life), survival, and relapse and disease-free survival.

A controlled prospective outcomes monitoring study of breast cancer IO care is an efficient method to assess the impact, or lack thereof, on outcomes of concern to patients and doctors care including quality of life, relapse rates, survival, and comorbitities. Within five years, it will be possible to collect enough data to describe the HRQOL outcomes associated with IO cases and women of similar prognosis who do not pursue IO care. We will also be able to provide some preliminary comparisons of the two groups’ health status when IO care is sought and prospectively thereafter, allowing for estimation of the effects of IO care. Such information is of importance to patients in the near-term future. While a randomized-controlled trial (RCT) would be the gold standard of evidence and should be pursued, an RCT of comprehensive IO care will be a difficult, expensive undertaking, and the appropriate data for the development of such a trial (who are the best candidates for treatment? What effect size should be anticipated?) are not currently available. Some may argue it is unethical to conduct an RCT in which some subjects receive no IO care.

What is needed in today’s cancer health-care environment are comparative effectiveness studies that address the question of whether the additional costs of IO cancer service is safe, effective and cost-effective. A matched controlled outcomes study that compares cancer outcomes between cancer patients who add IO care to their standard care versus matched patients who receive only standard care.

A reasonable early step in the evaluation of safety and effectiveness of CAM when used by cancer patients in real-world community clinics that provide whole-person physician-delivered integrated oncology evaluation and management that is integrated with standard care. The Western Washington Cancer Surveillance System (CSS) provides the controls for a prospective outcomes study of an IO breast cancer cohort. A nested case-control matched cohort with prospective assessment is an appropriate alternative, albeit, limited method to evaluate IO care.

Disease-Free Survival Data Will Require at Least Five Years of Prospective Outcomes Data

At least five years are required for disease-free survival in stage I–III cancer patients. We are collecting data on survival and disease-free survival outcomes in all members of our IO cancer cohort and in a matched comparison group who did not choose to use IO treatment for breast cancer. We have put in place the infrastructure for following these cohorts for years to come. We can describe and compare the frequency of use of a variety of CAM treatments by cancer patients who do and do not receive IO care from a physician-level practitioner. Using these data, we will estimate the contribution of self-prescribed CAM treatments to cancer survivor’s HRQOL in a community sample who do not seek advice from a physician-level CAM provider.

Bastyr/FHCRC Receive $3.1 Million Grant to Conduct an IO Clinic Outcomes Study in Breast Cancer

In July 2010, Bastyr University received a $3.1 million grant from NIH’s National Center for Complementary and Alternative Medicine to conduct a nested matched controlled cohort study of IO breast cancer care delivered by leading integrative oncology clinics in western Washington. The selected IO clinical sites include the Bastyr Integrative Oncology Research Center, Seattle Cancer Treatment & Wellness Center, Tahoma Clinic, and Providence Integrative Cancer Care. Robyn Andersen, PhD, associate professor and health psychologist at Fred Hutchinson Cancer Research Center, is coprincipal investigator on this NIH-funded study.

More information about Bastyr’s Integrative Oncology Research Center may be found at www.bastyr.edu/research/BIORC or by calling 425-602-3311.

To contact the four integrative oncology clinics participating in the NIH-funded study:

Bastyr Integrative Oncology Research Center

14500 Juanita Dr. NE

Kenmore WA

425-602-3311

Providence Integrative Cancer Care

4525 3rd Avenue South East 200

Lacey, WA, 98503

360-754-3934

Seattle Cancer Treatment & Wellness Center

900 Southwest 16th Street #100
Renton, WA 98057
425-204-7480

Tahoma Clinic

801 SW 16th St
Suite 121, Renton, WA 98057
425-264-0059

This work was supported by Cleavage Creek Winery and by NIH grant (R01 AT5873).

References

Standish LJ, Greene K, Greenlee H, Kim JG, Grosshans C. Complementary and alternative medical treatment of breast cancer: a survey of licensed North American naturopathic physicians. Altern Ther Health Med. 2002;8(5):68–70;72–75.

Standish LJ, Alschuler L, Ready AB, Sivam G, Torkelson C, Wenner C. Botanical medicine in integrative oncology. In: Abrams D, Weil A, eds. Integrative Oncology. Oxford University Press; 2008.

Standish LJ, Torkelson C, Hamill FA, et al. Immune defects in breast cancer patients after radiotherapy. J Soc Integr Oncol. 2008;6(3):110–121.

Standish L, Grosshans C, Lush J, Robeson M. Naturopathic medical approach to breast cancer. In: Tagliaferri M, Cohen I, Tripathy D, eds. Breast Cancer: Beyond Convention. New York: Pocket Books; 2002:478.