A Pilot Study of Working Women and Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Pilot Study of Working Women and Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01914614
• Other study ID #: IRB # 13-0560-P3H
• Secondary ID: K12DA035150
• Status: Completed
• Phase: N/A
• First received: July 26, 2013
• Last updated: May 26, 2015
• Start date: November 2013
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	UK Center for Clinical and Translational Science	Lexington	Kentucky
United States	University of Kentucky Markey Cancer Center	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Robin Vanderpool	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Breast cancer treatment adherence, including completion of prescribed chemotherapy regimens, prescribed radiation treatment regimen, and/or surgical follow-up appointments.	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	No
Secondary	Satisfaction with breast cancer treatment decision-making	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	No
Secondary	Quality of life	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	No