Breast CancerIO-OS-BCNCT01366248
Integrative Oncology Outcomes Study in Breast Cancer
An observational study of Breast Cancer, run by Bastyr University at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 750 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2010to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Red Cedar Wellness Center
Bellevue, Washington, 98004
Bastyr Integrative Oncology Research Center
Kenmore, Washington, 98028
Seattle Integrative Oncology at Providence Integrative Cancer Care
Lacey, Washington, 98503
Seattle Cancer Treatment & Wellness Center
Renton, Washington, 98057
Seattle Integrative Oncology at Institute of Complementary Medicine
Seattle, Washington, 98122
Tree of Health Integrative Medicine
Woodinville, Washington, 98072
About this study
Official title: Breast Cancer Integrative Oncology: Prospective Matched Controlled Outcomes Study
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
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6-60 months post-enrollment
Secondary outcomes (3)
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).
Measured: 6-60 months post-enrollment
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.
Measured: Baseline, 6, 12, 24, 48, and 60 months
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).
Measured: Baseline and 6, 12, 24, 36, 48 and 60 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startAug 2010
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bastyr University
- Sponsor type
- University, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center, National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH), Lotte & John Hecht Memorial Foundation
- Responsible party
- Sponsor
- Investigators
- Leanna J. Standish, ND, PhD, FABNO, Principal investigator, Bastyr UniversityM. Robyn Andersen, PhD, MPH, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366248
- Sponsor's protocol ID
- 09E-1237-01
- Other IDs
- 1R01AT005873
- Acronym
- IO-OS-BC
- Status last verified
- Mar 2018
- First submitted
- 31 May 2011
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29701107
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Integrative Oncology: Prospective Matched Controlled Outcomes Study
- ClinicalTrials.gov ID
- NCT01366248
- Acronym / sponsor ID
- IO-OS-BC / 09E-1237-01
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Bastyr UniversityUniversity, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center, National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH), Lotte & John Hecht Memorial Foundation
- Study start
- Aug 2010
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 6 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Aim 3: Collect pilot data on survival, comorbidities, and abnormal laboratory values.
Time frame: 6-60 months post-enrollment
Aim 4: Describe and compare CAM treatments
Time frame: Baseline, 6, 12, 24, 48, and 60 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Derived from this study: PubMed 29701107Standish 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leanna J. Standish, ND, PhD, FABNO principal investigator
Bastyr University
M. Robyn Andersen, PhD, MPH principal investigator
Fred Hutchinson Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Bastyr University at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01366248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.