NCT01914614

Brief Summary

The purpose of this research is to better understand the relationship between employment and breast cancer. Research is being conducted to understand how workplace factors influence breast cancer patients' ability to adhere to recommended cancer treatment and effectively recover from cancer. Investigators hope to use the findings from the study to help working breast cancer survivors make informed decisions about treatment and employment in collaboration with their employers and healthcare providers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

July 26, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 2, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

1.4 years

First QC Date

July 26, 2013

Last Update Submit

May 26, 2015

Conditions

Keywords

Breast CancerWorking Women

Outcome Measures

Primary Outcomes (1)

  • Guideline concordant breast cancer treatment as defined by National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology and oncologist assessments.

    Differences in receipt of guideline-concordant breast cancer treatment between working poor and working non-poor survivors as explained by variations in occupation and work organization factors associated with each group of women. Guideline-concordant treatment will be informed by National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology and oncologist assessments.

    6 months

Secondary Outcomes (3)

  • Breast cancer treatment adherence, including completion of prescribed chemotherapy regimens, prescribed radiation treatment regimen, and/or surgical follow-up appointments.

    6 months

  • Satisfaction with breast cancer treatment decision-making

    6 months

  • Quality of life

    6 months

Study Arms (2)

Working Poor Survivors

Low Wage workers

Non-Working Poor Survivors

Higher-Wage Salary Workers

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women diagnosed with a new, primary breast cancer within 3 months of enrollment and who were employed at the time of diagnosis.

You may qualify if:

  • Women age 18-65
  • Working at least 20 hours per week
  • Currently patients of the University of Kentucky Markey Cancer Center
  • Are able to read, write, and communicate in English
  • Have reliable telephone or Internet/Web access in or outside the home

You may not qualify if:

  • Self-employed
  • Unemployed
  • Cognitively impaired

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UK Center for Clinical and Translational Science

Lexington, Kentucky, 40536, United States

Location

University of Kentucky Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Robin Vanderpool, DrPH

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 26, 2013

First Posted

August 2, 2013

Study Start

November 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations