- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01134172
Ethnic Differences in the Impact of Breast Cancer on Employment Status, Financial Situation, and Quality of Life
June 23, 2025 updated by: Memorial Sloan Kettering Cancer Center
Breast Cancer and the Workforce: Ethnic Differences in the Impact of Breast Cancer on Employment Status, Financial Situation, and Quality of Life (BCW)
The purpose of this study is to learn more about how being treated for breast cancer affects patients' employment, financial situation, and quality of life on a short-term basis and on a long term basis.
Most studies of employment after breast cancer have focused on Caucasian women.This study will evaluate the impact of breast cancer on the lives of women from different ethnic groups.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
935
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
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Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Basking Ridge
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Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Monmouth
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New York
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Bronx, New York, United States, 10451
- NYC Health & Hospitals /Lincoln Medical Center
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Brooklyn, New York, United States, 11206
- Woodhull Medical and Mental Health Center
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Commack, New York, United States, 11725
- Memorial Sloan Kettering Commack
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Fresh Meadows, New York, United States, 11366
- Queens Medical Associates
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Harrison, New York, United States, 10604
- Memorial Sloan Kettering Westchester
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, United States, 10035
- Memorial Sloan Kettering at Ralph Lauren
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New York, New York, United States
- Bellevue Hospital Center
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Queens, New York, United States, 11355
- New York Presbyterian Queens
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Uniondale, New York, United States, 11553
- Memorial Sloan Kettering Nassau
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
We will recruit participants from Memorial Sloan-Kettering Cancer Center (MSKCC), four of its community-based outpatient treatment centers, and four urban community hospitals and clinics that serve large populations of ethnic minorities in New York City.
The MSKCC outpatient regional sites are located in New Jersey (Basking Ridge, Monmouth) and New York, with two in Long Island (Commack and Rockville Centre) and another in Westchester County.
Description
Inclusion Criteria:
Breast cancer survivors
- Pathologic diagnosis of stage I-III breast cancer
- Paid employment (full time or part time) at time of consent or in the three months prior to diagnosis
- Age 18 to 64 years (inclusive)
- The ability to give informed consent in Chinese (Mandarin), English, Korean, or Spanish.at MSK, New York Presbyterian Queens and Queens Medical Associates At NYC Health & Hospitals/ Lincoln Medical Center, patients must be able to give consent in English or Spanish.
- At the time of enrollment, participants must still be undergoing chemotherapy, undergoing radiation therapy, or planning surgery unless surgery is to be the only treatment modality. Those for whom treatment consists of surgery alone may have had their operation no more than 2 months prior to study enrollment. Participants need not have undergone surgical reconstruction prior to enrollment if the plan is to delay this procedure until after primary treatment is completed.
Comparison group
Paid employment (full time or part time) at the time of consent
- Age 18 to 64 years (inclusive) and within an age range that is 5 years above or below that of the nominating or matched survivor
- The ability to give informed consent in the same language as the nominating survivor
- Membership in the same ethnic group as the nominating survivor
- Not treated for cancer in the past year (other than non-melanoma skin cancer)
Exclusion Criteria:
- N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Breast cancer survivors
Women being treated for stage I-III breast cancer who were employed prior to this diagnosis will be recruited in their physicians' offices.
|
Patients will be asked to complete a questionnaire at baseline, and then one at follow up, 3-4 months after treatment completion.
The patient will be contacted one and two years after the completion of their follow up questionnaire for a brief one-question survey regarding current employment status.
A member of the study team will call a subset of patients who have completed both baseline and follow-up surveys to clarify responses to previous questions.
Patients will be considered lost to follow- up if surveys A or C have not been completed two years from the participant's consent date (participants who enroll but do not complete survey A are not prompted for survey C).
Deviations will not be filed until the end of the study, as there are opportunities over the course of study follow- up to collect previously missing information.
Patients will be asked to complete a questionnaire at baseline, and then one at follow up, 3-4 months after treatment completion.
All three follow-up contact methods (email, postcard, call) contain the same question regarding current employment status with minor modifications in formatting.
However, the employment question asked in all three follow-up contact methods is shown in the Postcard_Template document.
Due to the recent COVID-19 pandemic study staff will be working from home.
Therefore, calls will be made via MSK-approved platforms (e.g.
Jabber, etc.).
Participants who express concerns or request assistance related to COVID-19 will be referred to publicly available resources as needed (e.g., call 311 for access to health care or food panties, etc.) and will be noted in internal tracking logs.
The data collected for these internal tracking logs will be managed through a REDCap database.
|
|
Comparison group
Peer controls will be nominated by participants in the breast cancer survivor group or recruited by community outreach and matched for age, language, and ethnicity.
This cohort is no longer recruiting.
|
Patients will be asked to complete a questionnaire at baseline, and then one at follow up, 3-4 months after treatment completion.
The patient will be contacted one and two years after the completion of their follow up questionnaire for a brief one-question survey regarding current employment status.
A member of the study team will call a subset of patients who have completed both baseline and follow-up surveys to clarify responses to previous questions.
Patients will be considered lost to follow- up if surveys A or C have not been completed two years from the participant's consent date (participants who enroll but do not complete survey A are not prompted for survey C).
Deviations will not be filed until the end of the study, as there are opportunities over the course of study follow- up to collect previously missing information.
Patients will be asked to complete a questionnaire at baseline, and then one at follow up, 3-4 months after treatment completion.
All three follow-up contact methods (email, postcard, call) contain the same question regarding current employment status with minor modifications in formatting.
However, the employment question asked in all three follow-up contact methods is shown in the Postcard_Template document.
Due to the recent COVID-19 pandemic study staff will be working from home.
Therefore, calls will be made via MSK-approved platforms (e.g.
Jabber, etc.).
Participants who express concerns or request assistance related to COVID-19 will be referred to publicly available resources as needed (e.g., call 311 for access to health care or food panties, etc.) and will be noted in internal tracking logs.
The data collected for these internal tracking logs will be managed through a REDCap database.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To compare the impact of breast cancer on (a) employment status, (b) financial situation, and (c) QoL.
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To identify barriers to employment and correlates of employment status, financial situation, and QoL.
Time Frame: 3 years
|
3 years
|
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To develop the methodology to evaluate discrimination in the labor market using a validated instrument and to determine whether or not labor market discrimination is exacerbated by a diagnosis of breast cancer.
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Victoria Blinder, M.D., M.Sc., Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2010
Primary Completion (Estimated)
May 1, 2026
Study Completion (Estimated)
May 1, 2026
Study Registration Dates
First Submitted
May 27, 2010
First Submitted That Met QC Criteria
May 27, 2010
First Posted (Estimated)
May 31, 2010
Study Record Updates
Last Update Posted (Actual)
June 26, 2025
Last Update Submitted That Met QC Criteria
June 23, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-071
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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