- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01914614
A Pilot Study of Working Women and Breast Cancer
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentucky Markey Cancer Center
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Lexington, Kentucky, United States, 40536
- UK Center for Clinical and Translational Science
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Working Poor Survivors
Low Wage workers
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Non-Working Poor Survivors
Higher-Wage Salary Workers
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Breast cancer treatment adherence, including completion of prescribed chemotherapy regimens, prescribed radiation treatment regimen, and/or surgical follow-up appointments.
Time Frame: 6 months
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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.
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6 months
|
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Satisfaction with breast cancer treatment decision-making
Time Frame: 6 months
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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.
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6 months
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Quality of life
Time Frame: 6 months
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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.
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Robin Vanderpool, DrPH, University Of Kentucky
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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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