Integrative Oncology Outcomes Study in Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT01366248
- Lead Sponsor
- Bastyr University
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 750
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. 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. 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 Outcome Measures
Name Time Method Aim 3: Collect pilot data on survival, comorbidities, and abnormal laboratory values. 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 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 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).
Aim 4: Describe and compare CAM treatments 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.
Trial Locations
- Locations (6)
Bastyr Integrative Oncology Research Center
🇺🇸Kenmore, Washington, United States
Seattle Integrative Oncology at Providence Integrative Cancer Care
🇺🇸Lacey, Washington, United States
Seattle Cancer Treatment & Wellness Center
🇺🇸Renton, Washington, United States
Red Cedar Wellness Center
🇺🇸Bellevue, Washington, United States
Seattle Integrative Oncology at Institute of Complementary Medicine
🇺🇸Seattle, Washington, United States
Tree of Health Integrative Medicine
🇺🇸Woodinville, Washington, United States