A Pilot Study of Working Women and Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Kentucky
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robin Vanderpool, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01914614
First received: July 26, 2013
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Pilot Study of Working Women and Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Breast cancer treatment adherence, including completion of prescribed chemotherapy regimens, prescribed radiation treatment regimen, and/or surgical follow-up appointments. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Satisfaction with breast cancer treatment decision-making [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: November 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Working Poor Survivors
Low Wage workers
Non-Working Poor Survivors
Higher-Wage Salary Workers

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01914614

Contacts
Contact: Robin Vanderpool, DrPH 859-218-2102 robin@kcr.uky.edu

Locations
United States, Kentucky
University of Kentucky Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Robin Vanderpool, DrPH    859-218-2102    robin@kcr.uky.edu   
Principal Investigator: Robin Vanderpool, DrPH         
Sub-Investigator: Mara Chambers, MD         
UK Center for Clinical and Translational Science Recruiting
Lexington, Kentucky, United States, 40536
Contact: Dianne Richeson, CCRC, CRA    859-323-2093    dianne.richeson@uky.edu   
Contact: Dorothy Ross       dross3@email.uky.edu   
Sub-Investigator: Dianne Richeson         
Sponsors and Collaborators
Robin Vanderpool
Investigators
Principal Investigator: Robin Vanderpool, DrPH University of Kentucky
  More Information

No publications provided

Responsible Party: Robin Vanderpool, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT01914614     History of Changes
Other Study ID Numbers: IRB # 13-0560-P3H, K12DA035150
Study First Received: July 26, 2013
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Kentucky:
Breast Cancer
Working Women

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014