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Trial record 1 of 1 for:    NCT02494037
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The Canadian/US Integrative Oncology Study (CUSIOS)

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ClinicalTrials.gov Identifier: NCT02494037
Recruitment Status : Active, not recruiting
First Posted : July 10, 2015
Last Update Posted : October 24, 2022
Bastyr University
Lotte & John Hecht Memorial Foundation
Information provided by (Responsible Party):
The Canadian College of Naturopathic Medicine

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.

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 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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Study Type : Observational
Actual 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
Actual Study Start Date : January 2015
Actual Primary Completion Date : March 2022
Estimated Study Completion Date : March 2023

Primary Outcome Measures :
  1. Survival [ Time Frame: From date of diagnosis of stage IV or metastatic disease to 3 years post enrollment ]
    To measure the survival of AIO-treated patients as compared to survival data from the SEER database

Secondary Outcome Measures :
  1. Description of Integrative care [ 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: At baseline 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 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.

  3. Cost of Cancer Care [ Time Frame: At baseline and 6 months, 1 year, 2 years, and 3 years thereafter ]
    A sub group of Canadian AIO-treated patients will be enrolled to estimate direct healthcare, direct non-healthcare, and indirect non-healthcare costs from a societal perspective. This includes costs incurred by the healthcare payer (i.e. government or private insurers), the patient/family (i.e. co-payment or full payment for medicines and/or care) and by the society at large (i.e. costs of reduced productivity). Patients will self-report these costs using questionnaires developed by the research team in collaboration with a health economist.

  4. Qualitative Experience of Care (QEC) [ Time Frame: At baseline and 3 months, 6 months, 1 year, 2 years, and 3 years thereafter. ]
    A Sub group of Canadian AIO-treated patients and NDs at each Canadian clinic will be enrolled to understand the benefits and challenges of AIO care from a qualitative perspective. Through interviews conducted by a qualitative researcher, we will help to more fully understand the experiences of study participants and the subjective impact of naturopathic interventions both from the perspective of the study participants themselves and from the perspective of their ND.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

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

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United States, Arizona
Naturopathic Specialists, LLC (NSL)
Scottsdale, Arizona, United States, 85251
United States, Hawaii
Hawaii Integrative Oncology, Lokahi Health Center, Inc. (LHC)
Kailua, Hawaii, United States, 96740
United States, Washington
Salish Cancer Center (SCC)
Fife, Washington, United States, 98424
Seattle Integrative Cancer Center
Seattle, Washington, United States, 98057
Advanced Integrative Medical Science (AIMS) Institute
Seattle, Washington, United States, 98102
Bastyr Center for Natural Health
Seattle, Washington, United States, 98103
Tree of Health Integrative Medicine
Woodinville, Washington, United States, 98072
Canada, British Columbia
Integrated Health Clinic Cancer Care Centre
Fort Langley, British Columbia, Canada, V1M 2R4
Vital Victoria Naturopathic Clinic Ltd.
Victoria, British Columbia, Canada, V8X 3L8
Canada, Ontario
HealthSource Integrative Medical Centre
Kitchener, Ontario, Canada, N2H 2E6
Ottawa Integrative Cancer Centre (OICC)
Ottawa, Ontario, Canada, K1Y 2E5
Marsden Centre for Excellence in Integrative Medicine
Vaughan, Ontario, Canada, L4K 0G7
Sponsors and Collaborators
The Canadian College of Naturopathic Medicine
Bastyr University
Lotte & John Hecht Memorial Foundation
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Principal Investigator: Dugald Seely, ND, MSc Canadian College of Naturopathic Medicine
Principal Investigator: Leanna Standish, ND, PhD, FABNO Bastyr University
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Responsible Party: The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier: NCT02494037    
Other Study ID Numbers: 3974
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: October 24, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Gonadal Disorders