Integrative Oncology Outcomes Study in Breast Cancer (IO-OS-BC)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01366248 |
|
Recruitment Status :
Completed
First Posted : June 6, 2011
Last Update Posted : March 22, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease |
|---|
| Breast Cancer |
| Study Type : | Observational |
| Actual Enrollment : | 750 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Breast Cancer Integrative Oncology: Prospective Matched Controlled Outcomes Study |
| Study Start Date : | August 2010 |
| Actual Primary Completion Date : | December 31, 2017 |
| Actual Study Completion Date : | December 31, 2017 |
| Group/Cohort |
|---|
|
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.
|
- 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.
- 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 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).
- 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.
- 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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366248
| United States, Washington | |
| Red Cedar Wellness Center | |
| Bellevue, Washington, United States, 98004 | |
| Bastyr Integrative Oncology Research Center | |
| Kenmore, Washington, United States, 98028 | |
| Seattle Integrative Oncology at Providence Integrative Cancer Care | |
| Lacey, Washington, United States, 98503 | |
| Seattle Cancer Treatment & Wellness Center | |
| Renton, Washington, United States, 98057 | |
| Seattle Integrative Oncology at Institute of Complementary Medicine | |
| Seattle, Washington, United States, 98122 | |
| Tree of Health Integrative Medicine | |
| Woodinville, Washington, United States, 98072 | |
| Principal Investigator: | Leanna J. Standish, ND, PhD, FABNO | Bastyr University | |
| Principal Investigator: | M. Robyn Andersen, PhD, MPH | Fred Hutchinson Cancer Research Center |
| Responsible Party: | Bastyr University |
| ClinicalTrials.gov Identifier: | NCT01366248 |
| Other Study ID Numbers: |
09E-1237-01 1R01AT005873 ( U.S. NIH Grant/Contract ) |
| First Posted: | June 6, 2011 Key Record Dates |
| Last Update Posted: | March 22, 2018 |
| Last Verified: | March 2018 |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |