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Newly Diagnosed Breast CancerNCT01176838

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

An observational study of Newly Diagnosed Breast Cancer, run by Wake Forest University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Newly Diagnosed Breast Cancer
How many people
20 participants
Where
1 siteUnited States
Study dates
Nov 2008to Aug 2015
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Wake Forest University Department of Plastic & Reconstructive Surgery

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: 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.

Read the 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.

Keywords
Breast Cancer Quality of Life Survey

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2010 (estimated)
  2. Study startNov 2008
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01176838
Sponsor's protocol ID
IRB00007317
Status last verified
Jun 2017
First submitted
5 Aug 2010
Last updated
7 Nov 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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