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The Canadian/US Integrative Oncology Study (CUSIOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02494037
Recruitment Status : Active, not recruiting
First Posted : July 10, 2015
Last Update Posted : October 21, 2021
Sponsor:
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.
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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