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

NCT ID: NCT03039348

Last Updated: 2017-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Female Mastectomy Breast Reconstruction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Breast reconstruction

The patients choosing for breast reconstruction after mastectomy for breast cancer.

semi-structured interview using a questionnaire

Intervention Type OTHER

semi-structured interview using a questionnaire

No breast reconstruction

The patients not choosing breast reconstruction after mastectomy for breast cancer.

semi-structured interview using a questionnaire

Intervention Type OTHER

semi-structured interview using a questionnaire

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

semi-structured interview using a questionnaire

semi-structured interview using a questionnaire

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Laura Mettepenningen

student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Laura Mettepenningen

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

References

Explore related publications, articles, or registry entries linked to this study.

Ananian P, Houvenaeghel G, Protiere C, Rouanet P, Arnaud S, Moatti JP, Tallet A, Braud AC, Julian-Reynier C. Determinants of patients' choice of reconstruction with mastectomy for primary breast cancer. Ann Surg Oncol. 2004 Aug;11(8):762-71. doi: 10.1245/ASO.2004.11.027. Epub 2004 Jul 12.

Reference Type BACKGROUND
PMID: 15249342 (View on PubMed)

Fallbjork U, Karlsson S, Salander P, Rasmussen BH. Differences between women who have and have not undergone breast reconstruction after mastectomy due to breast cancer. Acta Oncol. 2010;49(2):174-9. doi: 10.3109/02841860903490069.

Reference Type BACKGROUND
PMID: 20100155 (View on PubMed)

Duggal CS, Metcalfe D, Sackeyfio R, Carlson GW, Losken A. Patient motivations for choosing postmastectomy breast reconstruction. Ann Plast Surg. 2013 May;70(5):574-80. doi: 10.1097/SAP.0b013e3182851052.

Reference Type BACKGROUND
PMID: 23542859 (View on PubMed)

Gopie JP, Hilhorst MT, Kleijne A, Timman R, Menke-Pluymers MB, Hofer SO, Mureau MA, Tibben A. Women's motives to opt for either implant or DIEP-flap breast reconstruction. J Plast Reconstr Aesthet Surg. 2011 Aug;64(8):1062-7. doi: 10.1016/j.bjps.2011.03.030. Epub 2011 Apr 22.

Reference Type BACKGROUND
PMID: 21514261 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

v2.0-11/01/2017-LauraM

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Living Well After Breast Surgery
NCT03834532 COMPLETED NA