The Canadian/US Integrative Oncology Study

It is estimated that between 50 and 80% of cancer patients in the United States (US)
supplement their conventional oncology treatment regimen with some form of complementary or
alternative medicine therapy or practice. A smaller percentage of these patients receive
medical treatment from naturopathic doctors (NDs) who are board certified in naturopathic
oncology (Fellows of the American Board of Naturopathic Oncology, FABNO) or have equivalent
experience in caring for cancer patients and from traditional Chinese medicine (TCM)
providers with advanced training in oncology (DAOM or physicians with training in TCM). This
level of care is being defined here as advanced integrative oncology (AIO). AIO clinics
provide comprehensive science- and experience-based naturopathic and Chinese medical oncology
integrated with each patient's conventional medical treatment.

Although there have been some studies of complementary and alternative medicine use by cancer
patients, little is known about the effectiveness of the naturopathic medicine and TCM
provided to people with cancer in an integrative setting. While there is scientific evidence
supporting specific treatments that are commonly used, systematic study of their
effectiveness (especially when used in combination as commonly recommended) is virtually
non-existent. An early step in the evaluation of clinical outcomes associated with AIO is to
take a health service approach and seek to answer the question: "Does exposure to AIO
services improve the clinical outcomes of patients with advanced stage cancer?"

The survival outcome of consecutively recruited advanced stage breast, colorectal,
pancreatic, and ovarian cancer patients treated at multiple naturopathic oncology clinics in
North America will be tracked and compared to outcomes published in the current medical
literature and by SEER (Surveillance, Epidemiology and End Results) in order to address the
fundamentally important question of whether or not AIO has a beneficial impact on survival.
Involvement of a total of seven active AIO clinics from Canada and the US will allow the
recruitment of a sufficient sample size to address this question as well as provide outcomes
that are generalizable for AIO across North America.

Inclusion Criteria:

- A new patient coming in for a first office call (FOC) with a participating site
investigator for their cancer or a current patient whose FOC with a participating
investigator for their cancer was after study start date of January 1, 2015

- ≥18 years of age

- Able to understand study design and provide signed informed consent to enrollment

- Confirmed diagnosis of one of the following cancers: stage 4 breast, stage 4
colorectal, stage 3 or 4 ovarian, or stage 3 or 4 pancreatic

- Canadian participants with a visit <3 months post-FOC are eligible for the HRQOL
sub-study

Exclusion Criteria: