Clinical trial NCT02494037: The Canadian/US Integrative Oncology Study
Official title: The Canadian/US Integrative Oncology Study (CUSIOS): Advanced Integrative Oncology Treatment for Patients With Advanced Stage Cancer: A Prospective Outcomes Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Colorectal Neoplasms
Pancreatic Neoplasms
Ovarian Neoplasms
Lead sponsor: The Canadian College of Naturopathic Medicine
Sponsor class: OTHER
Collaborators: name: Bastyr University
name: Lotte & John Hecht Memorial Foundation
First posted: 2015-07-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All stage 4 or metastatic breast or colorectal cancer patients and all stage 3 or 4 or metastatic ovarian and pancreatic cancer patients seeking care at the participating AIO clinical sites meeting inclusion/exclusion criteria are eligible to participate in this study.

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Survival
timeFrame: From date of diagnosis of stage IV or metastatic disease to 3 years post enrollment
Secondary outcomes:
measure: Description of Integrative care
timeFrame: At enrollment and up to 3 years
measure: Health-Related Quality of Life (HRQOL)
timeFrame: At baseline and 3 and 6 months and 1, 2 and 3 years thereafter.
measure: Cost of Cancer Care
timeFrame: At baseline and 6 months, 1 year, 2 years, and 3 years thereafter
measure: Qualitative Experience of Care (QEC)
timeFrame: At baseline and 3 months, 6 months, 1 year, 2 years, and 3 years thereafter.
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Naturopathic Specialists, LLC (NSL)
state: Arizona
city: Kailua
country: United States
facility: Hawaii Integrative Oncology, Lokahi Health Center, Inc. (LHC)
state: Hawaii
city: Fife
country: United States
facility: Salish Cancer Center (SCC)
state: Washington
city: Seattle
country: United States
facility: Seattle Integrative Cancer Center
state: Washington
city: Seattle
country: United States
facility: Advanced Integrative Medical Science (AIMS) Institute
state: Washington
city: Seattle
country: United States
facility: Bastyr Center for Natural Health
state: Washington
city: Woodinville
country: United States
facility: Tree of Health Integrative Medicine
state: Washington
city: Fort Langley
country: Canada
facility: Integrated Health Clinic Cancer Care Centre
state: British Columbia
city: Victoria
country: Canada
facility: Vital Victoria Naturopathic Clinic Ltd.
state: British Columbia
city: Kitchener
country: Canada
facility: HealthSource Integrative Medical Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Integrative Cancer Centre (OICC)
state: Ontario
city: Vaughan
country: Canada
facility: Marsden Centre for Excellence in Integrative Medicine
state: Ontario
Study officials:
affiliation: Canadian College of Naturopathic Medicine
name: Dugald Seely, ND, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Bastyr University
name: Leanna Standish, ND, PhD, FABNO
role: PRINCIPAL_INVESTIGATOR
References: