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Integrative Oncology Outcomes Study in Breast Cancer (IO-OS-BC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Fred Hutchinson Cancer Research Center
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Lotte & John Hecht Memorial Foundation
Information provided by (Responsible Party):
Bastyr University
ClinicalTrials.gov Identifier:
NCT01366248
First received: May 31, 2011
Last updated: March 28, 2016
Last verified: March 2016
History of Changes
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Breast Cancer Integrative Oncology: Prospective Matched Controlled Outcomes Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bastyr University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Aim 3: Collect pilot data on survival, comorbidities, and abnormal laboratory values. [ Time Frame: 6-60 months post-enrollment ] [ Designated as safety issue: No ]
    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).

  • Aim 4: Describe and compare CAM treatments [ Time Frame: Baseline, 6, 12, 24, 48, and 60 months ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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).
Estimated Enrollment: 725
Study Start Date: August 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

The patients enrolled into the study will include patients who meet the following criteria:

Cohort 1: IO clinic breast cancer patients

  1. Confirmed breast cancer of primary breast cancer with ICD9 code of 174.x, 233.0 or V10.3
  2. Female
  3. ≥18 years of age
  4. Can provide signed informed consent
  5. 1st IO clinic visit ≤3 months prior to enrollment
  6. 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.

  1. ICD9 code of 174.x or 233.0
  2. Primary ductal or lobular breast cancer diagnosis ≤2 years prior to 1st IO clinic visit
  3. Minimum of two IO clinic visits within 7 months
  4. Provided Baseline Questionnaire

Cohort 2: Matched controls from CSS database for Cohort 1A patients

  1. Confirmed breast cancer
  2. Female
  3. ≥ 18 years of age
  4. Can provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366248

Locations
United States, Washington
Red Cedar Wellness Center
Bellevue, Washington, United States, 98004
Seattle Integrative Oncology at Providence Integrative Cancer Care
Lacey, Washington, United States, 98503
Seattle Cancer Treatment & Wellness Center
Renton, Washington, United States, 98057
Bastyr Integrative Oncology at Bastyr Center for Natural Health
Seattle, Washington, United States, 98103
Seattle Integrative Oncology at Institute of Complementary Medicine
Seattle, Washington, United States, 98122
Tree of Health Integrative Medicine
Woodinville, Washington, United States, 98072
Sponsors and Collaborators
Bastyr University
Fred Hutchinson Cancer Research Center
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Lotte & John Hecht Memorial Foundation
Investigators
Principal Investigator: Leanna J. Standish, ND, PhD, FABNO Bastyr University
Principal Investigator: M. Robyn Andersen, PhD, MPH Fred Hutchinson Cancer Research Center
  More Information

Responsible Party: Bastyr University
ClinicalTrials.gov Identifier: NCT01366248     History of Changes
Other Study ID Numbers: 09E-1237-01  1R01AT005873 
Study First Received: May 31, 2011
Last Updated: March 28, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 29, 2016