This trial is active, not recruiting.

Condition breast cancer
Sponsor Bastyr University
Collaborator Fred Hutchinson Cancer Research Center
Start date August 2010
End date December 2018
Trial size 725 participants
Trial identifier NCT01366248, 09E-1237-01, 1R01AT005873


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Includes patients who are receiving care for their breast cancer at participating Seattle area IO clinics.
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.

Primary Outcomes

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.
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

Secondary Outcomes

Aim 3: Collect pilot data on survival, comorbidities, and abnormal laboratory values.
time frame: 6-60 months post-enrollment
Aim 4: Describe and compare CAM treatments
time frame: 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

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Breast Cancer Integrative Oncology: Prospective Matched Controlled Outcomes Study
Principal investigator Leanna J. Standish, ND, PhD, FABNO
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Bastyr University.