The Canadian/US Integrative Oncology Study

Breast Neoplasms Clinical Trial

— CUSIOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02494037
• Other study ID #: 3974
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2023
• Source: The Canadian College of Naturopathic Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 1, 2023
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Colorectal Neoplasms
• Neoplasms
• Ovarian Neoplasms
• Pancreatic Neoplasms

Locations

Country	Name	City	State
Canada	Integrated Health Clinic Cancer Care Centre	Fort Langley	British Columbia
Canada	HealthSource Integrative Medical Centre	Kitchener	Ontario
Canada	Ottawa Integrative Cancer Centre (OICC)	Ottawa	Ontario
Canada	Marsden Centre for Excellence in Integrative Medicine	Vaughan	Ontario
Canada	Vital Victoria Naturopathic Clinic Ltd.	Victoria	British Columbia
United States	Salish Cancer Center (SCC)	Fife	Washington
United States	Hawaii Integrative Oncology, Lokahi Health Center, Inc. (LHC)	Kailua	Hawaii
United States	Naturopathic Specialists, LLC (NSL)	Scottsdale	Arizona
United States	Advanced Integrative Medical Science (AIMS) Institute	Seattle	Washington
United States	Bastyr Center for Natural Health	Seattle	Washington
United States	Seattle Integrative Cancer Center	Seattle	Washington
United States	Tree of Health Integrative Medicine	Woodinville	Washington

Sponsors (3)

Lead Sponsor	Collaborator
The Canadian College of Naturopathic Medicine	Bastyr University, Lotte & John Hecht Memorial Foundation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	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	Description of Integrative care	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
Secondary	Health-Related Quality of Life (HRQOL)	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.
Secondary	Cost of Cancer Care	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
Secondary	Qualitative Experience of Care (QEC)	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.