Breast CancerNCT00145197
Reducing Underuse of Early-Stage Breast Cancer Treatment in Minority Communities
A study testing Improving the Delivery of Effective Care to Minorities in people with Breast Cancer, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The purpose of this study is to determine if a physician-centered intervention will help women with early stage breast cancer receive appropriate treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Improving the Delivery of Effective Care to Minorities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,164 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Dec 2007
- Phase
- Interventional
- 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
Who may be able to join
- All patients, who are English or Spanish speaking, with a new primary stage 1 or 2 breast cancer who have undergone either breast conserving surgery or mastectomy and those with tumors > 1 cm or < 1 cm and poorly differentiated
- All surgeons performing breast surgery at the participating hospitals
Who cannot join
- Patients with dementia or those with a poor prognosis due to end-stage organ failure or other concomitant conditions such as those undergoing treatment for other cancers
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Improving the Delivery of Effective Care to Minorities
The purpose of this study is to determine if a physician-centered intervention will help women with early stage breast cancer receive appropriate treatment.
Read the detailed description
Efficacious adjuvant treatments such as radiotherapy following breast conserving surgery, and chemo- or hormonal therapy for stage 1b or 2 breast cancer improve disease-free and overall survival. Lower rates of radiotherapy following breast-conserving surgery have been reported among black women. Few data exist about racial disparities in receipt of chemo- or hormonal therapies; however, poorer stage-specific survival rates among blacks and among women with poor or no insurance suggest underuse of these treatments. Despite elimination of racial disparities in rates of mammography screening, the full benefit of screening will not be realized unless underuse of effective treatments for early-stage breast cancer is eliminated. Little is known about reasons for underuse of these treatments or ways to increase treatment rates. Our preliminary work suggests omitted referrals and lack of follow-up tracking account for a majority of underuse particularly among minority patients.
The proposed breast cancer project will measure the extent of underuse of efficacious breast cancer treatments among patients of the hospitals serving East and Central Harlem and other minority communities in lower Manhattan. We will first interview physicians and patients about their reasons for omission of efficacious adjuvant treatments. At the 6 participating hospitals, we will then implement an intervention consisting of: a) computerized reminders to prompt surgeons to refer patients for adjuvant treatment, and b) an individual to track referrals for and receipt of adjuvant treatments. We will assess racial/ethnic differences in rates of underuse and explore racial differences in reasons for underuse.
We will assess the impact of the intervention on reducing underuse of efficacious therapies among 2 years of 695 pre-intervention and 2 years of 695 post-intervention patients. This study will provide new knowledge about racial disparities in treatment for early-stage breast cancer; patient and physician reasons for underuse; and the effectiveness of a simple, sustainable intervention to improve rates of efficacious adjuvant treatments.
- Conditions
- Breast Cancer
- Being tested
- Improving the Delivery of Effective Care to Minorities
- Keywords
- breast cancer, adjuvant treatment, racial disparities, Early-Stage 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.
Improving the Delivery of Effective Care to MinoritiesBehavioural
The intervention consists of: a) reminders to prompt surgeons to refer patients for adjuvant treatment, and b) an individual to track referrals for and receipt of adjuvant treatments. We will recruit all physicians who treat patients with early stage breast cancer. Physicians who agree to participate will identify a point person in their office who will inform the research team if the patient has a follow up appointment with radiation or medical oncologists. Following the appointment date, we will contact each office to confirm the patient's visit. If the patient has connected with radiation and/or medical oncologist, we will let the surgeon's office know and stop calling his/her office. However, if the patient has not made the appropriate visits, we will continue to call the surgeon's office every week for a total of 3 calls to let them know that the patient has not connected with the oncologist.
| Study group | Role | What they receive |
|---|---|---|
| Improving the Delivery of Effective Care to Minorities | Experimental | Not described Receives: Behavioral: Improving the Delivery of Effective Care to Minorities |
What is being measured
The primary outcome is the main question the study is designed to answer.
initiation and completion of primary treatment
Measured: measured 6 months after patient recruitment
Secondary outcomes (4)
adherence
Measured: measured at time of patient survey
emotional and health status
Measured: measured at time of patient survey
patient satisfaction
Measured: measured at time of patient survey
knowledge & beliefs
Measured: measured at time of patient survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nina Bickell, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145197
- Sponsor's protocol ID
- GCO 00-0053
- Other IDs
- 5P01HS010859-05
- Status last verified
- Dec 2013
- First submitted
- 2 Sep 2005
- Last updated
- 3 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Delivery of Effective Care to Minorities
- ClinicalTrials.gov ID
- NCT00145197
- Acronym / sponsor ID
- GCO 00-0053
- Conditions
- Breast Cancer
- Keywords
- breast cancer, adjuvant treatment, racial disparities, Early-Stage Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,164 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 5 Sep 2005 (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.
The purpose of this study is to determine if a physician-centered intervention will help women with early stage breast cancer receive appropriate treatment.
Detailed description
Efficacious adjuvant treatments such as radiotherapy following breast conserving surgery, and chemo- or hormonal therapy for stage 1b or 2 breast cancer improve disease-free and overall survival. Lower rates of radiotherapy following breast-conserving surgery have been reported among black women. Few data exist about racial disparities in receipt of chemo- or hormonal therapies; however, poorer stage-specific survival rates among blacks and among women with poor or no insurance suggest underuse of these treatments. Despite elimination of racial disparities in rates of mammography screening, the full benefit of screening will not be realized unless underuse of effective treatments for early-stage breast cancer is eliminated. Little is known about reasons for underuse of these treatments or ways to increase treatment rates. Our preliminary work suggests omitted referrals and lack of follow-up tracking account for a majority of underuse particularly among minority patients.
The proposed breast cancer project will measure the extent of underuse of efficacious breast cancer treatments among patients of the hospitals serving East and Central Harlem and other minority communities in lower Manhattan. We will first interview physicians and patients about their reasons for omission of efficacious adjuvant treatments. At the 6 participating hospitals, we will then implement an intervention consisting of: a) computerized reminders to prompt surgeons to refer patients for adjuvant treatment, and b) an individual to track referrals for and receipt of adjuvant treatments. We will assess racial/ethnic differences in rates of underuse and explore racial differences in reasons for underuse.
We will assess the impact of the intervention on reducing underuse of efficacious therapies among 2 years of 695 pre-intervention and 2 years of 695 post-intervention patients. This study will provide new knowledge about racial disparities in treatment for early-stage breast cancer; patient and physician reasons for underuse; and the effectiveness of a simple, sustainable intervention to improve rates of efficacious adjuvant treatments.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Improving the Delivery of Effective Care to Minorities | Experimental | Behavioral: Improving the Delivery of Effective Care to Minorities |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients, who are English or Spanish speaking, with a new primary stage 1 or 2 breast cancer who have undergone either breast conserving surgery or mastectomy and those with tumors > 1 cm or < 1 cm and poorly differentiated
- All surgeons performing breast surgery at the participating hospitals
Key exclusion criteria (1 listed)
- Patients with dementia or those with a poor prognosis due to end-stage organ failure or other concomitant conditions such as those undergoing treatment for other cancers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Improving the Delivery of Effective Care to MinoritiesThe intervention consists of: a) reminders to prompt surgeons to refer patients for adjuvant treatment, and b) an individual to track referrals for and receipt of adjuvant treatments. We will recruit all physicians who treat patients with early stage breast cancer. Physicians who agree to participate will identify a point person in their office who will inform the research team if the patient has a follow up appointment with radiation or medical oncologists. Following the appointment date, we will contact each office to confirm the patient's visit. If the patient has connected with radiation and/or medical oncologist, we will let the surgeon's office know and stop calling his/her office. However, if the patient has not made the appropriate visits, we will continue to call the surgeon's office every week for a total of 3 calls to let them know that the patient has not connected with the oncologist. | Behavioural | Improving the Delivery of Effective Care to Minorities |
Primary outcome
initiation and completion of primary treatment
Time frame: measured 6 months after patient recruitment
4 secondary outcomes
adherence
Time frame: measured at time of patient survey
emotional and health status
Time frame: measured at time of patient survey
patient satisfaction
Time frame: measured at time of patient survey
knowledge & beliefs
Time frame: measured at time of patient survey
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 3 Dec 2013.
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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.
Nina Bickell, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Improving the Delivery of Effective Care to Minorities in people with Breast Cancer, run by Icahn School of Medicine at Mount Sinai at 1 site 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?
The sponsor lists 2 inclusion and 1 exclusion criteria. 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 3 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
initiation and completion of primary treatment (time frame: measured 6 months after patient recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2013.