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

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03039348
• Other study ID #: v2.0-11/01/2017-LauraM
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 11, 2016
• Last updated: January 30, 2017
• Start date: December 2016
• Est. completion date: May 2017

Study information

• Verified date: January 2017
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Breast Reconstruction
• Mastectomy

Intervention

Other:
• semi-structured interview using a questionnaire
semi-structured interview using a questionnaire

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

References & Publications (4)

Ananian P, Houvenaeghel G, Protière 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. — View 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. — View Citation

Fallbjörk 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	factors influencing the choice concerning breast reconstruction after mastectomy, assessed with a questionnaire (with multiple choice and open questions)		december 2016 - may 2017