Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
400 participants
OBSERVATIONAL
2015-01-01
2023-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* ≥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/metastatic breast, stage 4/metastatic colorectal, stage 3 or 4/metasatic ovarian, or stage 3 or 4/metastatic pancreatic
* Canadian participants with a visit \<3 months post-FOC are eligible for the HRQOL sub-study
* Participants must be governed by the laws of the country within which they are receiving AIO care
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Bastyr University
OTHER
Lotte & John Hecht Memorial Foundation
OTHER
The Canadian College of Naturopathic Medicine
OTHER
Responsible Party
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Principal Investigators
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Dugald Seely, ND, MSc
Role: PRINCIPAL_INVESTIGATOR
Canadian College of Naturopathic Medicine
Leanna Standish, ND, PhD, FABNO
Role: PRINCIPAL_INVESTIGATOR
Bastyr University
Locations
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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
Ottawa Integrative Cancer Centre (OICC)
Ottawa, Ontario, Canada
Marsden Centre for Excellence in Integrative Medicine
Vaughan, Ontario, Canada
Countries
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Other Identifiers
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3974
Identifier Type: -
Identifier Source: org_study_id