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

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ClinicalTrials.gov Identifier: NCT01366248
Recruitment Status : Completed
First Posted : June 6, 2011
Last Update Posted : March 22, 2018
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

Tracking Information
First Submitted Date May 31, 2011
First Posted Date June 6, 2011
Last Update Posted Date March 22, 2018
Study Start Date August 2010
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 10, 2013)
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: June 2, 2011)
Changes in Health-Related Quality of Life (HRQOL) and differences in Clinical Outcomes in patients who use CAM at IO clinics compared to breast cancer patients who only use conventional treatment. [ Time Frame: 6, 12, 24, 36, 48, and 60 months post study enrollment. ]
Describe HRQOL & clinical outcomes of integrated conventional & naturopathic care during treatment & 6, 12, 24, 36, 48 & 60 months post enrollment. Each case enrolled at the IO clinics will be compared to 4 found through linking with data in the Cancer Surveillance System at FHCRC. Assessed outcomes include cancer symptoms, conventional treatment side effects, IO treatment adverse effects, HRQOL during treatment, compliance with recommended conventional & IO care, use of self-prescribed CAM, HRQOL in survivorship, achievement of disease free status, disease free survival, & overall survival.
Change History
Current Secondary Outcome Measures
 (submitted: June 10, 2013)
  • 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).
  • 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.
  • 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).
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Integrative Oncology Outcomes Study in Breast Cancer
Official Title Breast Cancer Integrative Oncology: Prospective Matched Controlled Outcomes Study
Brief Summary

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition Breast Cancer
Intervention Not Provided
Study 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.
Publications * Standish LJ, Dowd F, Sweet E, Dale L, Andersen MR. Do Women With Breast Cancer Who Choose Adjunctive Integrative Oncology Care Receive Different Standard Oncologic Treatment? Integr Cancer Ther. 2018 Sep;17(3):874-884. doi: 10.1177/1534735418769007. Epub 2018 Apr 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 27, 2017)
750
Original Estimated Enrollment
 (submitted: June 2, 2011)
1800
Actual Study Completion Date December 31, 2017
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01366248
Other Study ID Numbers 09E-1237-01
1R01AT005873 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bastyr University
Study Sponsor Bastyr University
Collaborators
  • 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
PRS Account Bastyr University
Verification Date March 2018