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Clinical Trials/NCT01176838
NCT01176838
Terminated
Not Applicable

A Prospective Study on Newly Diagnosed Breast Cancer Patients: A 5 Year Follow Up on Quality of Life

Wake Forest University1 site in 1 country20 target enrollmentNovember 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Newly Diagnosed Breast Cancer
Sponsor
Wake Forest University
Enrollment
20
Locations
1
Status
Terminated
Last Updated
8 years ago

Overview

Brief Summary

The purpose of this study is to provide the physicians with quality long term follow up data on subjects from the Breast Cancer Clinic and the Plastic Surgery Clinic who have been newly diagnosed with breast cancer and will receive treatment for the cancer at this facility. Over the last two decades many studies have been done concerning the quality of life after a mastectomy and/or reconstruction process. The majority of these studies only run for one year post reconstruction, some however, do include a two year follow up. The investigators are proposing a 5 year long term follow up study on subjects who will be diagnosed and treated here at the Breast Cancer Clinic and the Plastic Surgery Clinic. The investigators first questionnaire will be given prior to any treatment for breast cancer, giving us a baseline for the subject's current quality of life. At each successive year, the subject will be given another questionnaire with regards to their progression through the reconstructive process. At the end of 5 years, the subject will complete a final questionnaire. These questionnaires will deal with many areas of daily life functions; activities of daily living, anxiety, depression, social interactions, personal and sexual relationships.

Detailed Description

Upon informed consent of subject, a baseline questionnaire will be completed by the subject. At years 1, 2, 3, and 4 follow up questionnaires will be sent for completion to the subject. At year 5 a final questionnaire will be sent to the subject for completion.After all subjects have completed the study, data will be sent to the Department of Biostatics for analysis.

Registry
clinicaltrials.gov
Start Date
November 2008
End Date
August 2015
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Any female age 18 or over that has been diagnosed with breast cancer and has been treated and followed in the Breast Cancer Clinic and the Plastic Surgery Clinic is eligible for study participation.

Exclusion Criteria

  • Any person not meeting these requirements will not be eligible for study participation.

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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