The Canadian/US Integrative Oncology Study

NCT02494037 | Completed

• 1 other identifier: 3974
• Study Type: observational
• Target: 400
• Locations: 2 countries
• Sites: 12

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.

Conditions

Breast Neoplasms; Colorectal Neoplasms; Pancreatic Neoplasms; Ovarian Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Description of Integrative care

  At enrollment and up to 3 years

• Health-Related Quality of Life (HRQOL)

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

• Cost of Cancer Care

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

• Qualitative Experience of Care (QEC)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• The Canadian College of Naturopathic Medicine: lead
• Bastyr University: collaborator
• Lotte & John Hecht Memorial Foundation: collaborator

Study Sites (12)

Naturopathic Specialists, LLC (NSL)

Scottsdale, Arizona, 85251, United States

Location

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

Kailua, Hawaii, 96740, United States

Location

Salish Cancer Center (SCC)

Fife, Washington, 98424, United States

Location

Seattle Integrative Cancer Center

Seattle, Washington, 98057, United States

Location

Advanced Integrative Medical Science (AIMS) Institute

Seattle, Washington, 98102, United States

Location

Bastyr Center for Natural Health

Seattle, Washington, 98103, United States

Location

Tree of Health Integrative Medicine

Woodinville, Washington, 98072, United States

Location

Integrated Health Clinic Cancer Care Centre

Fort Langley, British Columbia, V1M 2R4, Canada

Location

Vital Victoria Naturopathic Clinic Ltd.

Victoria, British Columbia, V8X 3L8, Canada

Location

HealthSource Integrative Medical Centre

Kitchener, Ontario, N2H 2E6, Canada

Location

Ottawa Integrative Cancer Centre (OICC)

Ottawa, Ontario, K1Y 2E5, Canada

Location

Marsden Centre for Excellence in Integrative Medicine

Vaughan, Ontario, L4K 0G7, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Pancreatic Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue 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

Study Officials

• Dugald Seely, ND, MSc

  Canadian College of Naturopathic Medicine

  PRINCIPAL INVESTIGATOR

• Leanna Standish, ND, PhD, FABNO

  Bastyr University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2015
• First Posted: July 10, 2015
• Study Start: January 1, 2015
• Primary Completion: March 15, 2022
• Study Completion: December 1, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

CA (5); US (7)