Breast Cancer Clinical Trial

The Canadian/US Integrative Oncology Study

Summary

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.

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Full Description

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.

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Eligibility Criteria

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/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:

None

Study is for people with:

Breast Cancer

Estimated Enrollment:

400

Study ID:

NCT02494037

Recruitment Status:

Active, not recruiting

Sponsor:

The Canadian College of Naturopathic Medicine

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There are 12 Locations for this study

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Naturopathic Specialists, LLC (NSL)
Scottsdale Arizona, 85251, United States
Hawaii Integrative Oncology, Lokahi Health Center, Inc. (LHC)
Kailua Hawaii, 96740, United States
Salish Cancer Center (SCC)
Fife Washington, 98424, United States
Seattle Integrative Cancer Center
Seattle Washington, 98057, United States
Advanced Integrative Medical Science (AIMS) Institute
Seattle Washington, 98102, United States
Bastyr Center for Natural Health
Seattle Washington, 98103, United States
Tree of Health Integrative Medicine
Woodinville Washington, 98072, United States
Integrated Health Clinic Cancer Care Centre
Fort Langley British Columbia, V1M 2, Canada
Vital Victoria Naturopathic Clinic Ltd.
Victoria British Columbia, V8X 3, Canada
HealthSource Integrative Medical Centre
Kitchener Ontario, N2H 2, Canada
Ottawa Integrative Cancer Centre (OICC)
Ottawa Ontario, K1Y 2, Canada
Marsden Centre for Excellence in Integrative Medicine
Vaughan Ontario, L4K 0, Canada

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

400

Study ID:

NCT02494037

Recruitment Status:

Active, not recruiting

Sponsor:


The Canadian College of Naturopathic Medicine

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