A 5 Year Follow-up on Newly Diagnosed Breast Cancer Patients
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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 |
| 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) |
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 |
The study population will consist of females ages 18 and over that have been newly diagnosed with breast cancer.
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| 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 | |
| Principal Investigator: | Lisa R David, MD | Wake Forest University |
More Information
No publications provided
| Responsible Party: | Lisa R. David, MD, Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT01176838 History of Changes |
| Other Study ID Numbers: | IRB00007317 |
| Study First Received: | August 5, 2010 |
| Last Updated: | February 10, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Wake Forest University:
|
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 May 19, 2013