A Pilot Study of Working Women and Breast Cancer

May 26, 2015 updated by: Robin Vanderpool
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.

Study Overview

Status

Completed

Conditions

Detailed Description

Patients enrolled will be interviewed three times over a six month period. They will be asked questions about their experiences in managing their cancer while taking care of their job responsibilities. Patients will be asked to complete a survey that asks questions about their breast cancer treatment, their job, and how they manage their responsibilities while undergoing cancer treatment.

The first initial meeting will be conducted at a time and location that is convenient for the patient. This meeting should last about an hour to an hour and a half.

Three and six months after the initial interview, study participants will be asked to complete a follow-up survey by either telephone or Internet/Web, depending on their preference. These telephone surveys will last between 15-30 minutes.

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Markey Cancer Center
      • Lexington, Kentucky, United States, 40536
        • UK Center for Clinical and Translational Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability 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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Self-employed
  • Unemployed
  • Cognitively impaired

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Working Poor Survivors
Low Wage workers
Non-Working Poor Survivors
Higher-Wage Salary Workers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Guideline concordant breast cancer treatment as defined by National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology and oncologist assessments.
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breast cancer treatment adherence, including completion of prescribed chemotherapy regimens, prescribed radiation treatment regimen, and/or surgical follow-up appointments.
Time Frame: 6 months
Differences in breast cancer treatment adherence rates between working poor and non-poor survivors as explained by variations in occupation and work organization factors associated with each group of women.
6 months
Satisfaction with breast cancer treatment decision-making
Time Frame: 6 months
Differences in satisfaction with breast cancer treatment decision-making between working poor and working non-poor survivors as explained by variations in occupation and work organization factors associated with each group of women.
6 months
Quality of life
Time Frame: 6 months
Differences in quality of life measures between working poor and working non-poor survivors explained by variations in occupation and work organization factors associated with each group of women.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Robin Vanderpool, DrPH, University Of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

July 26, 2013

First Submitted That Met QC Criteria

August 1, 2013

First Posted (Estimate)

August 2, 2013

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • IRB # 13-0560-P3H
  • K12DA035150 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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