Opting for Breast Reconstruction After Mastectomy or Not: Search for Influencing Factors

January 30, 2017 updated by: Laura Mettepenningen, Universitair Ziekenhuis Brussel

Keuze Voor Wel of Geen Borstreconstructie na Mastectomie: Onderzoek Naar beïnvloedende Factoren

The purpose of this study is to investigate the factors influencing the decision about breast reconstruction after breast amputation for breast cancer.

The study will be conducted at the University Hospital in Brussels using only a questionnaire. The results might help us to evaluate and improve the satisfaction among patients about the received information and guidance.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The questionnaire will be completed during one interview. This interview will take place preferably right after the patient visited her doctor at the Breast Clinic at the University Hospital in Brussels.

Before starting the interview all the necessary information to decide whether or not to participate in the study will be given as well as the time to read the informed consent carefully.

Study Type

Observational

Enrollment (Anticipated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients of the Breast Clinic at the University Hospital in Brussels.

Description

Inclusion Criteria:

  • female
  • Dutch speaking
  • must have undergone a mastectomy for breast cancer in the following period: 2010 - 2015
  • must be a patient of the Breast Clinic at the University Hospital in Brussels

Exclusion Criteria:

  • bilateral preventive mastectomy (and therefore no history of breast cancer in any of the breasts)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast reconstruction
The patients choosing for breast reconstruction after mastectomy for breast cancer.
Other: semi-structured interview using a questionnaire
semi-structured interview using a questionnaire
No breast reconstruction
The patients not choosing breast reconstruction after mastectomy for breast cancer.
Other: semi-structured interview using a questionnaire
semi-structured interview using a questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
factors influencing the choice concerning breast reconstruction after mastectomy, assessed with a questionnaire (with multiple choice and open questions)
Time Frame: december 2016 - may 2017
december 2016 - may 2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: Laura Mettepenningen, Universitair Ziekenhuis Brussel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

December 11, 2016

First Submitted That Met QC Criteria

January 30, 2017

First Posted (Estimate)

February 1, 2017

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • v2.0-11/01/2017-LauraM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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