Skip to main content
OpenTrials
Completed

NCT Number: NCT01366248

Integrative Oncology Outcomes Study in Breast Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Red Cedar Wellness Center, Bellevue, Washington, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

The patients enrolled into the study will include patients who meet the following criteria:

Cohort 1: IO clinic breast cancer patients

  • Confirmed breast cancer of primary breast cancer with ICD9 code of 174.x, 233.0 or V10.3
  • Female
  • ≥18 years of age
  • Can provide signed informed consent
  • 1st IO clinic visit ≤3 months prior to enrollment
  • 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.

  • ICD9 code of 174.x or 233.0
  • Primary ductal or lobular breast cancer diagnosis ≤2 years prior to 1st IO clinic visit
  • Minimum of two IO clinic visits within 7 months
  • Provided Baseline Questionnaire

Cohort 2: Matched controls from CSS database for Cohort 1A patients

  • Confirmed breast cancer
  • Female
  • ≥ 18 years of age
  • Can provide informed consent

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Aim 3: Collect pilot data on survival, comorbidities, and abnormal laboratory values.

    Time frame: 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).

  2. Aim 4: Describe and compare CAM treatments

    Time frame: 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.

  3. Aim 5: Compare the HRQOL of women who self-prescribe CAM with those who do not

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Bastyr University

Other

Collaborators

  • Fred Hutchinson Cancer Center
  • Lotte & John Hecht Memorial Foundation
  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institutes of Health (NIH)

Registry information

Official study title

Breast Cancer Integrative Oncology: Prospective Matched Controlled Outcomes Study

Acronym: IO-OS-BC

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Jun 6, 2011
Registry last updated
Mar 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.