D. Seely (1,2), L. Standish (3), L. Dale (3), E. McDonell (2), D. Abdelfattah (2), E. Sweet (3), P. Chiang (3), K. Ronnie (3), F. Dowd (3), R. McLaughlin (3)
(1) Canadian College of Naturopathic Medicine, Toronto, Ontario, Canada; (2) Ottawa Integrative Cancer Centre, Ottawa, Ontario, Canada; (3) Bastyr University, Kenmore, Washington, United States of America
Background: The Canadian/US Integrative Oncology Study (CUSIOS) is a prospective, observational study of advanced stage cancer patients receiving Advanced Integrative Oncology (AIO) care by experienced naturopathic doctors.
Objectives: (1) Measure survival of advanced stage breast, colorectal, ovarian and pancreatic cancer patients receiving AIO treatments; (2) Describe AIO treatments recommended by naturopathic oncologists; (3) Pilot the collection of health-related quality of life (HR-QOL) data; (4) Evaluate the cost of AIO care; (5) Qualitatively describe the experience of AIO care.
Methods: CUSIOS is an uncontrolled, prospective observational study in 11 North American clinics. The sample size is 400 patients, which includes 80 patients each in HR-QOL and cost-analysis sub-studies. Eligibility criteria include adults with confirmed stage 4 breast or colorectal cancer, or stage 3 or 4 ovarian or pancreatic cancer receiving care from a participating AIO clinic, who consent. Data regarding conventional treatments, AIO treatments, diagnosis and survival are collected and will be compared to the medical literature, and Surveillance, Epidemiology and End Results (SEER) database. Data from validated questionnaires and qualitative interviews are collected to evaluate HR-QOL, cost utilization and patient experience.
Results: Study recruitment began January 2015 with 6 sites. Enrollment as of June 2018 is 278, with an expansion to 11 sites. Enrollment for HR-QOL is complete, and screening for cost analysis began May, 2018. Expected completion including follow up is July 2022.
Conclusions: This is the first multi-centre, prospective observational study evaluating survival outcomes for patients receiving AIO care in North America. Findings from the study will inform the profession and public of the potential impact that AIO has on survival and quality of life. In addition, this research will provide a thorough description of the range of therapies recommended by experienced naturopathic oncologists, cost utilization by patients, and a longitudinal analysis of patient experience.