NCT01134172

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
935

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Longer than P75 for all trials

Geographic Reach
1 country

12 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2010

Completed
15.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

16 years

First QC Date

May 27, 2010

Last Update Submit

June 23, 2025

Conditions

Keywords

SociodemographicEthnicityWork-relatedHealth systemQOLQuestionnaires10-071

Outcome Measures

Primary Outcomes (1)

  • To compare the impact of breast cancer on (a) employment status, (b) financial situation, and (c) QoL.

    3 years

Secondary Outcomes (2)

  • To identify barriers to employment and correlates of employment status, financial situation, and QoL.

    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.

    3 years

Study Arms (2)

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.

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.

Behavioral: survey web-based or telephone interview

Interventions

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.

Breast cancer survivors

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Woodhull Medical and Mental Health Center

Brooklyn, New York, 11206, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Queens Medical Associates

Fresh Meadows, New York, 11366, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering at Ralph Lauren

New York, New York, 10035, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Bellevue Hospital Center

New York, New York, United States

Location

New York Presbyterian Queens

Queens, New York, 11355, United States

Location

NYC Health & Hospitals /Lincoln Medical Center

The Bronx, New York, 10451, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Victoria Blinder, M.D., M.Sc.

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2010

First Posted

May 31, 2010

Study Start

May 1, 2010

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

June 26, 2025

Record last verified: 2025-06

Locations