The Canadian/US Integrative Oncology Study (CUSIOS)

• ClinicalTrials.gov Identifier: NCT02494037
• Recruitment Status: Active, not recruiting
• First Posted: July 10, 2015
• Last Update Posted: October 21, 2021
• Sponsor: The Canadian College of Naturopathic Medicine
• Collaborators: Bastyr University; Lotte & John Hecht Memorial Foundation
• Information provided by (Responsible Party): The Canadian College of Naturopathic Medicine

Tracking Information

• First Submitted Date: July 3, 2015
• First Posted Date: July 10, 2015
• Last Update Posted Date: October 21, 2021
• Actual Study Start Date: January 2015
• Estimated Primary Completion Date: March 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 19, 2020)

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

Original Primary Outcome Measures (submitted: July 7, 2015)

Survival [ Time Frame: From first AIO clinic visit up to 3 years ]

Participants' vital status including date and cause of death will be queried annually beginning one year after first participant enrollment for three years.

Current Secondary Outcome Measures (submitted: August 19, 2020)

• 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.
• 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.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: July 7, 2015)

• AIO and Conventional Oncology Treatments [ 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.
• Health-Related Quality of Life (HRQOL) [ Time Frame: At enrollment and 3 and 6 months and 1, 2 and 3 years from first AIO clinic visit ]
  Self-reported HRQOL data will be collected from a subgroup of Canadian AIO-treated patients (N=80) 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

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

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: July 7, 2015): 400
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2023
• Estimated Primary Completion Date: March 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT02494037
• Other Study ID Numbers: 3974
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: The Canadian College of Naturopathic Medicine
• Original Responsible Party: Same as current
• Current Study Sponsor: The Canadian College of Naturopathic Medicine
• Original Study Sponsor: Same as current

Collaborators

• Bastyr University
• Lotte & John Hecht Memorial Foundation

Investigators

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

• PRS Account: The Canadian College of Naturopathic Medicine
• Verification Date: October 2021