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

This study is currently recruiting participants.
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
  Purpose

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.


Condition
Newly Diagnosed Breast Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Prospective Study on Newly Diagnosed Breast Cancer Patients: A 5 Year Follow Up on Quality of Life

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Estimated Enrollment: 300
Study Start Date: November 2008
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176838

Locations
United States, North Carolina
Wake Forest University Department of Plastic & Reconstructive Surgery Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Lisa R David, MD    336-716-4171    ldavid@wfubmc.edu   
Contact: Denise M Voignier, CCRP    336-713-4339    dvoignie@wfubmc.edu   
Principal Investigator: Lisa R David, MD         
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Lisa R David, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Lisa David, Professor, Wake Forest University
ClinicalTrials.gov Identifier: NCT01176838     History of Changes
Other Study ID Numbers: IRB00007317
Study First Received: August 5, 2010
Last Updated: September 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Breast Cancer Quality of Life Survey

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

ClinicalTrials.gov processed this record on April 21, 2014