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The Canadian/US Integrative Oncology Study (CUSIOS)

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ClinicalTrials.gov Identifier: NCT02494037
Recruitment Status : Recruiting
First Posted : July 10, 2015
Last Update Posted : July 25, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study describes the three-year survival outcome of consecutively recruited advanced stage breast, colorectal, ovarian and pancreatic cancer patients receiving advanced integrative oncology (AIO) treatment at one of the participating North American advanced integrative oncology specialist clinics. This study also aims to describe AIO treatments recommended by naturopathic oncologists for these advanced stage cancer patients and pilot the collection and evaluation of health-related quality of life data on a subset of Canadian AIO-treated patients.

Condition or disease
Breast Neoplasms Colorectal Neoplasms Pancreatic Neoplasms Ovarian Neoplasms

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 medical treatment 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 consecutively recruited 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 published in the current medical literature and by SEER (Surveillance, Epidemiology and End Results) in order to address the fundamentally important question of whether or not AIO has a beneficial impact on survival. Involvement of a total of seven active AIO 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 are generalizable for AIO across North America.

Study Design

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Canadian/US Integrative Oncology Study (CUSIOS): Advanced Integrative Oncology Treatment for Patients With Advanced Stage Cancer: A Prospective Outcomes Study
Study Start Date : January 2015
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Survival [ Time Frame: From first AIO clinic visit up to 3 years ]
    Participants' vital status including date and cause of death will be queried annually beginning one year after first participant enrollment for three years.

Secondary Outcome Measures :
  1. AIO and Conventional Oncology Treatments [ Time Frame: At enrollment and up to 3 years ]
    AIO treatment recommendations for cancer and conventional oncology treatment data will be collected to describe the cancer treatments recommended and/or used by cancer patients across the treatment cohort. AIO treatment recommendations will be abstracted from AIO chart notes for all study participants for the first AIO clinic visit and up to 3 years. Concurrent conventional oncology treatment data will also be abstracted from conventional oncology medical charts.

  2. Health-Related Quality of Life (HRQOL) [ Time Frame: Prior to first AIO clinic visit and 3 and 6 months and 1, 2 and 3 years thereafter. ]
    Self-reported HRQOL data will be collected from a subgroup of Canadian AIO-treated patients (N=80) who had at least two AIO visits within three months of first AIO clinic visit using validated questionnaires commonly used in integrative oncology research settings. Instruments to be used in the HRQOL assessment include the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) to measure general health status and function, Measure Yourself Concerns and Wellbeing (MYCaW) to identify cancer-related concerns, and Edmonton Symptom Assessment Scale (ESAS) to assess common cancer symptoms.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All stage 4 breast or colorectal cancer patients and all stage 3 or 4 ovarian and pancreatic cancer patients seeking care at the participating AIO clinical sites meeting inclusion/exclusion criteria are eligible to participate in this study.

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 breast, stage 4 colorectal, stage 3 or 4 ovarian, or stage 3 or 4 pancreatic
  • Canadian participants with a visit <3 months post-FOC are eligible for the HRQOL sub-study

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494037

Contact: Dugald Seely, ND, MSc 613-792-1222 dseely@oicc.ca
Contact: Leanna Standish, ND, PhD, FABNO 425-602-3166 ljs@bastyr.edu

United States, Arizona
Naturopathic Specialists, LLC (NSL) Recruiting
Scottsdale, Arizona, United States, 85251
Contact: Dan Rubin, ND, FABNO    480-990-1111    rubinhere@me.com   
Principal Investigator: Dan Rubin, ND, FABNO         
Sub-Investigator: Melissa Coats, ND         
United States, Hawaii
Hawaii Integrative Oncology, Lokahi Health Center, Inc. (LHC) Recruiting
Kailua-Kona, Hawaii, United States, 96740
Contact: Michael Traub, ND, DHANP, FABNO    808-329-2114    mtraubnd@me.com   
Principal Investigator: Michael Traub, ND, DHANP, FABNO         
United States, Washington
Red Cedar Wellness Center Recruiting
Bellevue, Washington, United States, 98004
Contact: Erin Sweet, ND, MPH, FABNO    425-451-0999    info@redcedarwellness.com   
Principal Investigator: Erin Sweet, ND, MPH, FABNO         
Sub-Investigator: Laura James, ND, FABNO         
Salish Cancer Center (SCC) Recruiting
Fife, Washington, United States, 98424
Contact: Paul Reilly, ND, FABNO    253-382-6300    paul.reilly@salishcancercenter.com   
Principal Investigator: Paul Reilly, ND, FABNO         
Shelby Naturopathy, PLLC Recruiting
Seattle, Washington, United States, 98103
Contact: Leanna Standish, ND, FABNO    425-602-3166    ljs@bastyr.edu   
Principal Investigator: Leanna Standish, ND, PhD, FABNO         
Tree of Health Integrative Medicine Recruiting
Woodinville, Washington, United States, 98072
Contact: Eleonora Naydis, ND, LAc, FABNO    425-408-0040    drnaydis@treeofhealthmedicine.com   
Principal Investigator: Eleonora Naydis, ND, LAc, FABNO         
Canada, British Columbia
Integrated Health Clinic Cancer Care Centre Recruiting
Fort Langley, British Columbia, Canada, V1M 2R4
Contact: Gurdev Parmar, ND, FABNO    604-888-8325    drgparmar@integratedhealthclinic.com   
Principal Investigator: Gurdev Parmar, ND, FABNO         
Sub-Investigator: Erin Rurak, ND         
Vital Victoria Naturopathic Clinic Ltd. Active, not recruiting
Victoria, British Columbia, Canada, V8X 3L8
Canada, Ontario
HealthSource Integrative Medical Centre Recruiting
Kitchener, Ontario, Canada, N2H 2E6
Contact: Michael Reid, ND    (519) 954-7950    drreid@healthsourceimc.com   
Sub-Investigator: Som Thammasouk, ND         
Sub-Investigator: Camille Krause, ND         
Ottawa Integrative Cancer Center (OICC) Recruiting
Ottawa, Ontario, Canada, K1Y 2E5
Contact: Dugald Seely, ND, MSc    613-792-1222    dseely@oicc.ca   
Principal Investigator: Dugald Seely, ND, MSc         
Sub-Investigator: Craig Herrington, ND         
Sub-Investigator: Gillian Flower, ND         
Sub-Investigator: Ellen McDonell, ND         
Marsden Centre for Excellence in Integrative Medicine Recruiting
Vaughan, Ontario, Canada, L4K 0G7
Contact: Eric Marsden, ND    905-508-4498    eric.marsden@marsdencentre.com   
Principal Investigator: Eric Marsden, ND         
Sub-Investigator: Rebecca Lee, ND         
Sub-Investigator: Ashley Chauvin, ND         
Sponsors and Collaborators
The Canadian College of Naturopathic Medicine
Bastyr University
Lotte & John Hecht Memorial Foundation
Principal Investigator: Dugald Seely, ND, MSc Canadian College of Naturopathic Medicine
Principal Investigator: Leanna Standish, ND, PhD, FABNO Bastyr University
More Information

Responsible Party: The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier: NCT02494037     History of Changes
Other Study ID Numbers: 3974
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2016

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Pancreatic Neoplasms
Ovarian Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Gonadal Disorders