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

Bastyr University

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01366248

09E-1237-01

1R01AT005873 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 750 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

750 participants in 2 patient groups

IO Clinic Breast Cancer Patients

Description:

Includes patients who are receiving care for their breast cancer at participating Seattle area IO clinics.

CSS Match-Control Patients

Description:

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.