- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01366248
Integrative Oncology Outcomes Study in Breast Cancer (IO-OS-BC)
Breast Cancer Integrative Oncology: Prospective Matched Controlled Outcomes Study
This NIH-NCCAM funded epidemiologic research is being conducted as an observational prospective case-control study of the use of Complementary and Alternative Medicine (CAM) and Integrated Oncology (IO) and their effects on breast cancer patients in community settings.
Hypothesis: IO services improve patients' quality of life and decrease cancer recurrence rates in breast cancer patients as compared to women with similar disease states and prognoses who do not receive IO care, and may or may not use CAM treatment on their own.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Washington
-
Bellevue, Washington, United States, 98004
- Red Cedar Wellness Center
-
Kenmore, Washington, United States, 98028
- Bastyr Integrative Oncology Research Center
-
Lacey, Washington, United States, 98503
- Seattle Integrative Oncology at Providence Integrative Cancer Care
-
Renton, Washington, United States, 98057
- Seattle Cancer Treatment & Wellness Center
-
Seattle, Washington, United States, 98122
- Seattle Integrative Oncology at Institute of Complementary Medicine
-
Woodinville, Washington, United States, 98072
- Tree of Health Integrative Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Eligible participants for the study will include patients who are receiving care for their cancer at participating Seattle area IO clinics. An average of two (up to four) matched comparison controls will be recruited from the Washington State CSS.
All breast cancer patients seeking care at the participating IO clinics who meet inclusion/exclusion criteria are eligible to participate in this study. Matched comparison cases from CSS will be identified by CSS and confirmed by the FHCRC investigator.
Description
The patients enrolled into the study will include patients who meet the following criteria:
Cohort 1: IO clinic breast cancer patients
- Confirmed breast cancer of primary breast cancer with ICD9 code of 174.x, 233.0 or V10.3
- Female
- ≥18 years of age
- Can provide signed informed consent
- 1st IO clinic visit ≤3 months prior to enrollment
- Can read and understand the questionnaires
Cohort 1A: Sub-cohort of IO clinic patients (cases) who meet the following additional criteria and for whom matched controls have been found from the CSS database.
- ICD9 code of 174.x or 233.0
- Primary ductal or lobular breast cancer diagnosis ≤2 years prior to 1st IO clinic visit
- Minimum of two IO clinic visits within 7 months
- Provided Baseline Questionnaire
Cohort 2: Matched controls from CSS database for Cohort 1A patients
- Confirmed breast cancer
- Female
- ≥ 18 years of age
- Can provide informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
IO Clinic Breast Cancer Patients
Includes patients who are receiving care for their breast cancer at participating Seattle area IO clinics.
|
CSS Match-Control Patients
For each IO clinic patient, an average of two (up to four) matched comparison cases will be recruited from the Washington State Cancer Surveillance System (CSS).
Matched comparison cases from CSS will be identified by CSS and confirmed by the FHCRC investigator.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aim 1: Describe treatments received by breast cancer patients receiving physician level practitioner IO care and the cost of IO care.
Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months post study enrollment.
|
Will also describe how long after diagnosis women with breast cancer seek IO care and differences in IO care prescriptions associated with when, in a woman's course of treatment, she seeks care.
This patient cohort will consist of all female patients with breast cancer seeking IO clinic care.
Our analyses will describe how long after diagnosis women with breast cancer seek IO care and describe differences in IO care prescriptions associated with when, in a woman's course of treatment, she seeks care.
|
Baseline, 6, 12, 24, 36, 48, and 60 months post study enrollment.
|
Aim 2: Compare health-related quality of life (HRQOL) experienced by a group of breast cancer patients receiving IO care with HRQOL of a group of matched comparison women.
Time Frame: 6-60 months post-enrollment
|
Comparison will be between breast cancer patients living in the same geographic area with similar prognostic characteristics (age, stage of cancer at diagnosis, estrogen receptor/ progesterone receptor (ER/PR) status, race, ethnicity, and marital status) at the time of their initial diagnosis with breast cancer who did not receive IO care.
We will identify an average of three (up to four each) matched controls for each eligible IO clinic cancer patient from the Western Washington CSS database and to invite them to enroll in the outcomes study.
|
6-60 months post-enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aim 3: Collect pilot data on survival, comorbidities, and abnormal laboratory values.
Time Frame: 6-60 months post-enrollment
|
Collect pilot data on disease-free, progression free, and overall survival, as well as comorbidities and abnormal laboratory values at 6 months post-enrollment for all Cohort 1 and Cohort 2. We will collect data at 1 year post-enrollment and then yearly on disease-free, progression free, and overall survival, as well as comorbidities for as long as funding is available in a nested cohort of IO breast cancer patients (Cohort 1A) and their matched comparison group who did not receive care at any of the IO clinical sites (Cohort 2).
|
6-60 months post-enrollment
|
Aim 4: Describe and compare CAM treatments
Time Frame: Baseline, 6, 12, 24, 48, and 60 months
|
Describe and compare the frequency of use of a variety of CAM treatments used by breast cancer patients who do (Cohort 1A) and do not (Cohorts 2A and 2B) receive IO care from an IO specialist.
|
Baseline, 6, 12, 24, 48, and 60 months
|
Aim 5: Compare the HRQOL of women who self-prescribe CAM with those who do not
Time Frame: Baseline and 6, 12, 24, 36, 48 and 60 months post-enrollment
|
To compare baseline and changes in HRQOL in breast cancer patients who self-prescribe CAM (Cohort 2B) matched with comparison women who do not use CAM (Cohort 2A).
|
Baseline and 6, 12, 24, 36, 48 and 60 months post-enrollment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Leanna J. Standish, ND, PhD, FABNO, Bastyr University
- Principal Investigator: M. Robyn Andersen, PhD, MPH, Fred Hutchinson Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09E-1237-01
- 1R01AT005873 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer