Opting for Breast Reconstruction After Mastectomy or Not: Search for Influencing Factors
Keuze Voor Wel of Geen Borstreconstructie na Mastectomie: Onderzoek Naar beïnvloedende Factoren
1 other identifier
observational
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2016
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 11, 2016
CompletedFirst Posted
Study publicly available on registry
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedFebruary 1, 2017
January 1, 2017
5 months
December 11, 2016
January 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
factors influencing the choice concerning breast reconstruction after mastectomy, assessed with a questionnaire (with multiple choice and open questions)
december 2016 - may 2017
Study Arms (2)
Breast reconstruction
The patients choosing for breast reconstruction after mastectomy for breast cancer.
No breast reconstruction
The patients not choosing breast reconstruction after mastectomy for breast cancer.
Interventions
semi-structured interview using a questionnaire
Eligibility Criteria
Patients of the Breast Clinic at the University Hospital in Brussels.
You may qualify if:
- 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
You may not qualify if:
- bilateral preventive mastectomy (and therefore no history of breast cancer in any of the breasts)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
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.
PMID: 15249342BACKGROUNDFallbjork 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.
PMID: 20100155BACKGROUNDDuggal 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.
PMID: 23542859BACKGROUNDGopie 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.
PMID: 21514261BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Mettepenningen
Universitair Ziekenhuis Brussel
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- student
Study Record Dates
First Submitted
December 11, 2016
First Posted
February 1, 2017
Study Start
December 1, 2016
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
February 1, 2017
Record last verified: 2017-01