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Clinical Trials/NCT01366248
NCT01366248
Completed
Not Applicable

Breast Cancer Integrative Oncology: Prospective Matched Controlled Outcomes Study

Bastyr University6 sites in 1 country750 target enrollmentAugust 2010
ConditionsBreast Cancer

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.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
December 31, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

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)

Study Sites (6)

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