Integrative Oncology Outcomes Study in Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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IO Clinic Breast Cancer Patients

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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No