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

Tracking Information
First Submitted Date	May 27, 2010
First Posted Date	May 31, 2010
Last Update Posted Date	June 6, 2018
Actual Study Start Date	May 2010
Estimated Primary Completion Date	May 2019 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: June 1, 2010)	To compare the impact of breast cancer on (a) employment status, (b) financial situation, and (c) QoL. [ Time Frame: 3 years ]
Original Primary Outcome Measures; (submitted: May 27, 2010)	To compare the impact of breast cancer on (a) employment status, (b) financial situation, and (c) QoL in women of different ethnic groups. [ Time Frame: 3 years ]
Change History	Complete list of historical versions of study NCT01134172 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: June 1, 2010)	To identify barriers to employment and correlates of employment status, financial situation, and QoL. [ Time Frame: 3 years ]; 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 ]
Original Secondary Outcome Measures; (submitted: May 27, 2010)	To identify barriers to employment and correlates of employment status, financial situation, and QoL among breast cancer survivors from different ethnic groups. [ Time Frame: 3 years ]; 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 ]
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Ethnic Differences in the Impact of Breast Cancer on Employment Status, Financial Situation, and Quality of Life
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)
Brief 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 longterm 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.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Case-Control; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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.
Condition	Breast Cancer
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.; 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.
Study Groups/Cohorts	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. Intervention: Behavioral: survey web-based or telephone interview; 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. Intervention: Behavioral: survey web-based or telephone interview
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Recruiting
Estimated Enrollment; (submitted: May 27, 2010)	750
Original Estimated Enrollment	Same as current
Estimated Study Completion Date	May 2019
Estimated Primary Completion Date	May 2019 (Final data collection date for primary outcome measure)
Eligibility Criteria	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:
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years to 64 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts	Contact: Victoria Blinder, M.D., M.Sc. 646-888-8216 Contact: Francesca Gany, M.D., M.Sc. 646-888-8054
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT01134172
Other Study ID Numbers	10-071
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Memorial Sloan Kettering Cancer Center
Study Sponsor	Memorial Sloan Kettering Cancer Center
Collaborators	The City College of New York; NYC Health & Hospitals/ Lincoln Medical Center; New York Presbyterian Queens; Ralph Lauren Center for Cancer Care and Prevention; New York City Health and Hospitals Corporation; Queens Medical Associates
Investigators	Principal Investigator: Victoria Blinder, M.D., M.Sc. Memorial Sloan Kettering Cancer Center
PRS Account	Memorial Sloan Kettering Cancer Center
Verification Date	June 2018