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Breast NeoplasmsCUSIOSNCT02494037

The Canadian/US Integrative Oncology Study

An observational study of Breast Neoplasms and Colorectal Neoplasms, run by The Canadian College of Naturopathic Medicine at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
400 participants
Where
12 sitesin 2 countries
Study dates
1 Jan 2015to 1 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • None

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

United States7 sites

  • Salish Cancer Center (SCC)

    Fife, Washington, 98424

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

    Kailua, Hawaii, 96740

  • Naturopathic Specialists, LLC (NSL)

    Scottsdale, Arizona, 85251

  • Seattle Integrative Cancer Center

    Seattle, Washington, 98057

  • Advanced Integrative Medical Science (AIMS) Institute

    Seattle, Washington, 98102

  • Bastyr Center for Natural Health

    Seattle, Washington, 98103

  • Tree of Health Integrative Medicine

    Woodinville, Washington, 98072

Other trials in United States

Canada5 sites

  • Integrated Health Clinic Cancer Care Centre

    Fort Langley, British Columbia, V1M 2R4

  • HealthSource Integrative Medical Centre

    Kitchener, Ontario, N2H 2E6

  • Ottawa Integrative Cancer Centre (OICC)

    Ottawa, Ontario, K1Y 2E5

  • Marsden Centre for Excellence in Integrative Medicine

    Vaughan, Ontario, L4K 0G7

  • Vital Victoria Naturopathic Clinic Ltd.

    Victoria, British Columbia, V8X 3L8

Other trials in Canada

About this study

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

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.

Read the 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.

Medical subject headings
Breast Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms, Ovarian Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival

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

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

Secondary outcomes (4)

  1. 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.

    Measured: At enrollment and up to 3 years

  2. 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.

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

  3. 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.

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

  4. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2015 (estimated)
  2. Study start1 Jan 2015
  3. Primary completion15 Mar 2022
  4. Study completion1 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02494037
Sponsor's protocol ID
3974
Acronym
CUSIOS
Status last verified
Dec 2023
First submitted
3 Jul 2015
Last updated
14 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Neoplasms and Colorectal Neoplasms, run by The Canadian College of Naturopathic Medicine at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival (time frame: From date of diagnosis of stage IV or metastatic disease to 3 years post enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02494037.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.

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