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The Canadian/US Integrative Oncology Study

NCT02494037CompletedOBSERVATIONAL

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.

Key Facts

Lead Sponsor

The Canadian College of Naturopathic Medicine

Enrollment

400

Start Date

2015-01-01

Completion Date

2022-03-15

Study Type

OBSERVATIONAL

Official Title

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

Conditions

Breast NeoplasmsColorectal NeoplasmsPancreatic NeoplasmsOvarian Neoplasms

Eligibility

Age Range

18 Years+

Sex

ALL

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

Outcome Measures

Primary Outcomes

Survival

To measure the survival of AIO-treated patients as compared to survival data from the SEER database

Time frame: From date of diagnosis of stage IV or metastatic disease to 3 years post enrollment

Secondary Outcomes

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.

Time frame: At enrollment and up to 3 years

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.

Time frame: At baseline and 3 and 6 months and 1, 2 and 3 years thereafter.

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.

Time frame: At baseline and 6 months, 1 year, 2 years, and 3 years thereafter

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.

Time frame: At baseline and 3 months, 6 months, 1 year, 2 years, and 3 years thereafter.

Locations

Naturopathic Specialists, LLC (NSL), Scottsdale, United States

Hawaii Integrative Oncology, Lokahi Health Center, Inc. (LHC), Kailua, United States

Salish Cancer Center (SCC), Fife, United States

Seattle Integrative Cancer Center, Seattle, United States

Advanced Integrative Medical Science (AIMS) Institute, Seattle, United States

Bastyr Center for Natural Health, Seattle, United States

Tree of Health Integrative Medicine, Woodinville, United States

Integrated Health Clinic Cancer Care Centre, Fort Langley, Canada

Vital Victoria Naturopathic Clinic Ltd., Victoria, Canada

HealthSource Integrative Medical Centre, Kitchener, Canada

Ottawa Integrative Cancer Centre (OICC), Ottawa, Canada

Marsden Centre for Excellence in Integrative Medicine, Vaughan, Canada

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.