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

Newly Diagnosed Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01176838
• Other study ID #: IRB00007317
• Status: Terminated
• Phase: N/A
• First received: August 5, 2010
• Last updated: November 3, 2017
• Start date: November 2008
• Est. completion date: August 2015

Study information

• Verified date: June 2017
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Newly Diagnosed Breast Cancer

Locations

Country	Name	City	State
United States	Wake Forest University Department of Plastic & Reconstructive Surgery	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University

Country where clinical trial is conducted

United States,