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The Canadian/US Integrative Oncology Study (CUSIOS): Advanced Integrative Oncology Treatment for Patients With Advanced Stage Cancer: A Prospective Outcomes Study
This study describes the survival outcomes of advanced stage breast, colorectal, ovarian and pancreatic cancer patients receiving advanced integrative oncology (AIO) treatment at participating North American integrative oncology clinics. This study also aims to describe the integrative treatments recommended by naturopathic doctors (NDs) for these participants alongside their conventional care treatments. Sub-studies will evaluate health-related quality of life, cost of cancer care, and qualitative experience of care in a subset of Canadian participants.
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 care 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 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 from the SEER (Surveillance, Epidemiology and End Results) database in order to address the fundamentally important question of whether or not AIO has a beneficial impact on survival. Involvement of a total of twelve 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 enhance the generalizability for AIO across North America.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Naturopathic Specialists, LLC (NSL)
Scottsdale, Arizona, United States
Hawaii Integrative Oncology, Lokahi Health Center, Inc. (LHC)
Kailua, Hawaii, United States
Salish Cancer Center (SCC)
Fife, Washington, United States
Seattle Integrative Cancer Center
Seattle, Washington, United States
Advanced Integrative Medical Science (AIMS) Institute
Seattle, Washington, United States
Bastyr Center for Natural Health
Seattle, Washington, United States
Tree of Health Integrative Medicine
Woodinville, Washington, United States
Integrated Health Clinic Cancer Care Centre
Fort Langley, British Columbia, Canada
Vital Victoria Naturopathic Clinic Ltd.
Victoria, British Columbia, Canada
HealthSource Integrative Medical Centre
Kitchener, Ontario, Canada
Start Date
January 1, 2015
Primary Completion Date
March 15, 2022
Completion Date
December 1, 2023
Last Updated
December 14, 2023
400
ACTUAL participants
Lead Sponsor
The Canadian College of Naturopathic Medicine
Collaborators
NCT06662786
NCT07191730
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06312176