Integrative Oncology Outcomes Study in Breast Cancer

NCT01366248 | Completed DMC

• 2 other identifiers: 09E-1237-011R01AT005873
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 6

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (3)

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

  6-60 months post-enrollment

• Aim 4: Describe and compare CAM treatments

  Baseline, 6, 12, 24, 48, and 60 months

• 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

Study Arms (2)

IO Clinic Breast Cancer Patients

Includes patients who are receiving care for their breast cancer at participating Seattle area IO clinics.

CSS Match-Control Patients

For each IO clinic patient, an average of two (up to four) matched comparison cases will be recruited from the Washington State Cancer Surveillance System (CSS). Matched comparison cases from CSS will be identified by CSS and confirmed by the FHCRC investigator.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (6)

Red Cedar Wellness Center

Bellevue, Washington, 98004, United States

Location

Bastyr Integrative Oncology Research Center

Kenmore, Washington, 98028, United States

Location

Seattle Integrative Oncology at Providence Integrative Cancer Care

Lacey, Washington, 98503, United States

Location

Seattle Cancer Treatment & Wellness Center

Renton, Washington, 98057, United States

Location

Seattle Integrative Oncology at Institute of Complementary Medicine

Seattle, Washington, 98122, United States

Location

Tree of Health Integrative Medicine

Woodinville, Washington, 98072, United States

Location

Related Publications (1)

• 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.

  PMID: 29701107 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Leanna J. Standish, ND, PhD, FABNO

  Bastyr University

  PRINCIPAL INVESTIGATOR

• M. Robyn Andersen, PhD, MPH

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 6, 2011
• Study Start: August 1, 2010
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 22, 2018

Record last verified: 2018-03

Locations

US (6)