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A 5 Year Follow-up on Newly Diagnosed Breast Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Wake Forest School of Medicine
Sponsor:
Information provided by (Responsible Party):
Lisa David, Wake Forest University
ClinicalTrials.gov Identifier:
NCT01176838
First received: August 5, 2010
Last updated: September 5, 2013
Last verified: September 2013

August 5, 2010
September 5, 2013
November 2008
December 2014   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01176838 on ClinicalTrials.gov Archive Site
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A 5 Year Follow-up on Newly Diagnosed Breast Cancer Patients
A Prospective Study on Newly Diagnosed Breast Cancer Patients: A 5 Year Follow Up on Quality of Life

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.

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.

Observational
Time Perspective: Prospective
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Non-Probability Sample

The study population will consist of females ages 18 and over that have been newly diagnosed with breast cancer.

Newly Diagnosed Breast Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
December 2020
December 2014   (final data collection date for primary outcome measure)

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.

Female
18 Years and older
No
United States
 
NCT01176838
IRB00007317
No
Lisa David, Wake Forest University
Wake Forest School of Medicine
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Principal Investigator: Lisa R David, MD Wake Forest School of Medicine
Wake Forest School of Medicine
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP