NCT03039348

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

December 11, 2016

Last Update Submit

January 30, 2017

Conditions

Keywords

Breast Cancer FemaleMastectomyBreast Reconstructionquestionnaire

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.

Other: 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

Interventions

semi-structured interview using a questionnaire

Breast reconstructionNo breast reconstruction

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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: 15249342BACKGROUND
  • 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.

    PMID: 20100155BACKGROUND
  • 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.

    PMID: 23542859BACKGROUND
  • 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.

    PMID: 21514261BACKGROUND

Study Officials

  • Laura Mettepenningen

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

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