Clinical trial NCT01134172: 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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: Sociodemographic
Ethnicity
Work-related
Health system
QOL
Questionnaires
10-071
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: The City College of New York
name: NYC Health & Hospitals/ Lincoln Medical Center
name: New York Presbyterian Queens
name: New York City Health and Hospitals Corporation
name: Queens Medical Associates
First posted: 2010-05-31
Enrollment: 935
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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 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.


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:

* N/A

Primary outcomes:
measure: To compare the impact of breast cancer on (a) employment status, (b) financial situation, and (c) QoL.
timeFrame: 3 years
Secondary outcomes:
measure: To identify barriers to employment and correlates of employment status, financial situation, and QoL.
timeFrame: 3 years
measure: 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.
timeFrame: 3 years
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Bronx
country: United States
facility: NYC Health & Hospitals /Lincoln Medical Center
state: New York
city: Brooklyn
country: United States
facility: Woodhull Medical and Mental Health Center
state: New York
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Fresh Meadows
country: United States
facility: Queens Medical Associates
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering at Ralph Lauren
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Bellevue Hospital Center
state: New York
city: Queens
country: United States
facility: New York Presbyterian Queens
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Victoria Blinder, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: