The Canadian/US Integrative Oncology Study (CUSIOS)

December 13, 2023 updated by: The Canadian College of Naturopathic Medicine

The Canadian/US Integrative Oncology Study (CUSIOS): Advanced Integrative Oncology Treatment for Patients With Advanced Stage Cancer: A Prospective Outcomes Study

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Fort Langley, British Columbia, Canada, V1M 2R4
        • Integrated Health Clinic Cancer Care Centre
      • Victoria, British Columbia, Canada, V8X 3L8
        • Vital Victoria Naturopathic Clinic Ltd.
    • Ontario
      • Kitchener, Ontario, Canada, N2H 2E6
        • HealthSource Integrative Medical Centre
      • Ottawa, Ontario, Canada, K1Y 2E5
        • Ottawa Integrative Cancer Centre (OICC)
      • Vaughan, Ontario, Canada, L4K 0G7
        • Marsden Centre for Excellence in Integrative Medicine
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Naturopathic Specialists, LLC (NSL)
    • Hawaii
      • Kailua, Hawaii, United States, 96740
        • Hawaii Integrative Oncology, Lokahi Health Center, Inc. (LHC)
    • Washington
      • Fife, Washington, United States, 98424
        • Salish Cancer Center (SCC)
      • Seattle, Washington, United States, 98103
        • Bastyr Center for Natural Health
      • Seattle, Washington, United States, 98057
        • Seattle Integrative Cancer Center
      • Seattle, Washington, United States, 98102
        • Advanced Integrative Medical Science (AIMS) Institute
      • Woodinville, Washington, United States, 98072
        • Tree of Health Integrative Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of diagnosis of stage IV or metastatic disease to 3 years post enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At enrollment and up to 3 years
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.
At baseline and 3 and 6 months and 1, 2 and 3 years thereafter.
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.
At baseline and 6 months, 1 year, 2 years, and 3 years thereafter
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.
At baseline and 3 months, 6 months, 1 year, 2 years, and 3 years thereafter.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Canadian College of Naturopathic Medicine

Collaborators

Bastyr University
Lotte & John Hecht Memorial Foundation

Investigators

  • Principal Investigator: Leanna Standish, ND, PhD, FABNO, Bastyr University
  • Principal Investigator: Dugald Seely, ND, MSc, Canadian College of Naturopathic Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

March 15, 2022

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

July 3, 2015

First Submitted That Met QC Criteria

July 7, 2015

First Posted (Estimated)

July 10, 2015

Study Record Updates

Last Update Posted (Estimated)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3974

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Neoplasms

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe