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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01134172
Other study ID # 10-071
Secondary ID
Status Recruiting
Phase N/A
First received May 27, 2010
Last updated March 16, 2017
Start date May 2010
Est. completion date May 2018

Study information

Verified date March 2017
Source Memorial Sloan Kettering Cancer Center
Contact Victoria Blinder, M.D., M.Sc.
Phone 646-888-8216
Is FDA regulated No
Health authority
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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 750
Est. completion date May 2018
Est. primary completion date May 2018
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:

Study Design


Related Conditions & MeSH terms


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.
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.

Locations

Country Name City State
United States Memoral Sloan Kettering Cancer Center 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 Cancer Center @ Suffolk Commack New York
United States Queens Medical Associates Fresh Meadows 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 Cancer Center New York New York
United States Ralph Lauren Center for Cancer Care and Prevention New York New York
United States New York Presbyterian Queens Queens New York
United States Memorial Sloan Kettering at Mercy Medical Center Rockville Centre New York
United States Memorial Sloan Kettering West Harrison West Harrison New York

Sponsors (7)

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, Ralph Lauren Center for Cancer Care and Prevention, 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
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