Breast Cancer Integrative Oncology: Prospective Matched Controlled Outcomes Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Bastyr University
- Enrollment
- 750
- Locations
- 6
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Aim 3: Collect pilot data on survival, comorbidities, and abnormal laboratory values.(6-60 months post-enrollment)
- Aim 5: Compare the HRQOL of women who self-prescribe CAM with those who do not(Baseline and 6, 12, 24, 36, 48 and 60 months post-enrollment)
- Aim 4: Describe and compare CAM treatments(Baseline, 6, 12, 24, 48, and 60 months)