Clinical trial NCT01366248: Integrative Oncology Outcomes Study in Breast Cancer
Official title: Breast Cancer Integrative Oncology: Prospective Matched Controlled Outcomes Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Bastyr University
Sponsor class: OTHER
Collaborators: name: Fred Hutchinson Cancer Center
name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
name: Lotte & John Hecht Memorial Foundation
First posted: 2011-06-06
Enrollment: 750
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible participants for the study will include patients who are receiving care for their cancer at participating Seattle area IO clinics. An average of two (up to four) matched comparison controls will be recruited from the Washington State CSS.

All breast cancer patients seeking care at the participating IO clinics who meet inclusion/exclusion criteria are eligible to participate in this study. Matched comparison cases from CSS will be identified by CSS and confirmed by the FHCRC investigator.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Aim 1: Describe treatments received by breast cancer patients receiving physician level practitioner IO care and the cost of IO care.
timeFrame: Baseline, 6, 12, 24, 36, 48, and 60 months post study enrollment.
measure: 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.
timeFrame: 6-60 months post-enrollment
Secondary outcomes:
measure: Aim 3: Collect pilot data on survival, comorbidities, and abnormal laboratory values.
timeFrame: 6-60 months post-enrollment
measure: Aim 4: Describe and compare CAM treatments
timeFrame: Baseline, 6, 12, 24, 48, and 60 months
measure: Aim 5: Compare the HRQOL of women who self-prescribe CAM with those who do not
timeFrame: Baseline and 6, 12, 24, 36, 48 and 60 months post-enrollment
Other outcomes:
Locations:
city: Bellevue
country: United States
facility: Red Cedar Wellness Center
state: Washington
city: Kenmore
country: United States
facility: Bastyr Integrative Oncology Research Center
state: Washington
city: Lacey
country: United States
facility: Seattle Integrative Oncology at Providence Integrative Cancer Care
state: Washington
city: Renton
country: United States
facility: Seattle Cancer Treatment & Wellness Center
state: Washington
city: Seattle
country: United States
facility: Seattle Integrative Oncology at Institute of Complementary Medicine
state: Washington
city: Woodinville
country: United States
facility: Tree of Health Integrative Medicine
state: Washington
Study officials:
affiliation: Bastyr University
name: Leanna J. Standish, ND, PhD, FABNO
role: PRINCIPAL_INVESTIGATOR
affiliation: Fred Hutchinson Cancer Center
name: M. Robyn Andersen, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Standish LJ, Dowd F, Sweet E, Dale L, Andersen MR. Do Women With Breast Cancer Who Choose Adjunctive Integrative Oncology Care Receive Different Standard Oncologic Treatment? Integr Cancer Ther. 2018 Sep;17(3):874-884. doi: 10.1177/1534735418769007. Epub 2018 Apr 27.