Integrative Oncology Outcomes Study in Breast Cancer

Breast Cancer Clinical Trial

— IO-OS-BC  

Official title:

Breast Cancer Integrative Oncology: Prospective Matched Controlled Outcomes Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366248
• Other study ID #: 09E-1237-01
• Secondary ID: 1R01AT005873
• Status: Completed
• First received: May 31, 2011
• Last updated: March 21, 2018
• Start date: August 2010
• Est. completion date: December 31, 2017

Study information

• Verified date: March 2018
• Source: Bastyr University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	Red Cedar Wellness Center	Bellevue	Washington
United States	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	Seattle Integrative Oncology at Institute of Complementary Medicine	Seattle	Washington
United States	Tree of Health Integrative Medicine	Woodinville	Washington

Sponsors (5)

Lead Sponsor	Collaborator
Bastyr University	Fred Hutchinson Cancer Research Center, Lotte & John Hecht Memorial Foundation, National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aim 1: Describe treatments received by breast cancer patients receiving physician level practitioner IO care and the cost of IO care.	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.	Baseline, 6, 12, 24, 36, 48, and 60 months post study enrollment.
Primary	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.	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.	6-60 months post-enrollment
Secondary	Aim 3: Collect pilot data on survival, comorbidities, and abnormal laboratory values.	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).	6-60 months post-enrollment
Secondary	Aim 4: Describe and compare CAM treatments	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.	Baseline, 6, 12, 24, 48, and 60 months
Secondary	Aim 5: Compare the HRQOL of women who self-prescribe CAM with those who do not	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).	Baseline and 6, 12, 24, 36, 48 and 60 months post-enrollment