Ethnic Differences in the Impact of Breast Cancer on Employment Status, Financial Situation, and Quality of Life

Breast Cancer Clinical Trial

Official title:

Breast Cancer and the Workforce: Ethnic Differences in the Impact of Breast Cancer on Employment Status, Financial Situation, and Quality of Life (BCW)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01134172
• Other study ID #: 10-071
• Status: Active, not recruiting
• Start date: May 2010
• Est. completion date: May 2025

Study information

• Verified date: February 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 935
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• survey web-based or telephone interview
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.
• survey web-based or telephone interview
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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	NYC Health & Hospitals /Lincoln Medical Center	Bronx	New York
United States	Woodhull Medical and Mental Health Center	Brooklyn	New York
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Queens Medical Associates	Fresh Meadows	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Bellevue Hospital Center	New York	New York
United States	Memorial Sloan Kettering at Ralph Lauren	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	New York Presbyterian Queens	Queens	New York
United States	Memorial Sloan Kettering Nassau	Uniondale	New York

Sponsors (6)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	New York City Health and Hospitals Corporation, New York Presbyterian Queens, NYC Health & Hospitals/ Lincoln Medical Center, Queens Medical Associates, The City College of New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the impact of breast cancer on (a) employment status, (b) financial situation, and (c) QoL.		3 years
Secondary	To identify barriers to employment and correlates of employment status, financial situation, and QoL.		3 years
Secondary	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.		3 years

External Links

•   Memorial Sloan Kettering Cancer Center