Clinical trial NCT03039348: Opting for Breast Reconstruction After Mastectomy or Not: Search for Influencing Factors
Official title: Keuze Voor Wel of Geen Borstreconstructie na Mastectomie: Onderzoek Naar beïnvloedende Factoren
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer Female
Mastectomy
Breast Reconstruction
Keywords: Breast Cancer Female
Mastectomy
Breast Reconstruction
questionnaire
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2017-02-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the Breast Clinic at the University Hospital in Brussels.

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: factors influencing the choice concerning breast reconstruction after mastectomy, assessed with a questionnaire (with multiple choice and open questions)
timeFrame: december 2016 - may 2017
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Laura Mettepenningen
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.