Breast Cancer FemaleNCT03039348
Opting for Breast Reconstruction After Mastectomy or Not: Search for Influencing Factors
An observational study of Breast Cancer Female and Mastectomy, run by Universitair Ziekenhuis Brussel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female, Mastectomy, Breast Reconstruction
- What is being tested?
- semi-structured interview using a questionnaire
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients of the Breast Clinic at the University Hospital in Brussels.
Who may be able to join
- 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
Who cannot join
- bilateral preventive mastectomy (and therefore no history of breast cancer in any of the breasts)
About this study
Official title: Keuze Voor Wel of Geen Borstreconstructie na Mastectomie: Onderzoek Naar beïnvloedende Factoren
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.
Read the 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.
- Conditions
- Breast Cancer Female, Mastectomy, Breast Reconstruction
- Being tested
- semi-structured interview using a questionnaire
- Keywords
- Breast Cancer Female, Mastectomy, Breast Reconstruction, questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi-structured interview using a questionnaireOther
semi-structured interview using a questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Breast reconstruction | The patients choosing for breast reconstruction after mastectomy for breast cancer. Receives: Other: semi-structured interview using a questionnaire | |
| No breast reconstruction | The patients not choosing breast reconstruction after mastectomy for breast cancer. Receives: Other: semi-structured interview using a questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
factors influencing the choice concerning breast reconstruction after mastectomy, assessed with a questionnaire (with multiple choice and open questions)
Measured: december 2016 - may 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study startDec 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Mettepenningen, Universitair Ziekenhuis Brussel
- Investigators
- Laura Mettepenningen, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039348
- Sponsor's protocol ID
- v2.0-11/01/2017-LauraM
- Status last verified
- Jan 2017
- First submitted
- 11 Dec 2016
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: undecided
Publications
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.
PubMed 15249342Fallbjork 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.
PubMed 20100155Duggal 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.
PubMed 23542859Gopie 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.
PubMed 21514261
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keuze Voor Wel of Geen Borstreconstructie na Mastectomie: Onderzoek Naar beïnvloedende Factoren
- ClinicalTrials.gov ID
- NCT03039348
- Acronym / sponsor ID
- v2.0-11/01/2017-LauraM
- Conditions
- Breast Cancer Female, Mastectomy, Breast Reconstruction
- Keywords
- Breast Cancer Female, Mastectomy, Breast Reconstruction, questionnaire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast reconstruction | – | Other: semi-structured interview using a questionnaireThe patients choosing for breast reconstruction after mastectomy for breast cancer. |
| No breast reconstruction | – | Other: semi-structured interview using a questionnaireThe patients not choosing breast reconstruction after mastectomy for breast cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the Breast Clinic at the University Hospital in Brussels.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- bilateral preventive mastectomy (and therefore no history of breast cancer in any of the breasts)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semi-structured interview using a questionnairesemi-structured interview using a questionnaire | Other | Breast reconstruction, No breast reconstruction |
Primary outcome
factors influencing the choice concerning breast reconstruction after mastectomy, assessed with a questionnaire (with multiple choice and open questions)
Time frame: december 2016 - may 2017
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Background: PubMed 15249342Ananian 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.
- Background: PubMed 20100155Fallbjork 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.
- Background: PubMed 23542859Duggal 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.
- Background: PubMed 21514261Gopie 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.
- Individual participant dataSharing planned: Undecided. undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Mettepenningen principal investigator
Universitair Ziekenhuis Brussel
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female and Mastectomy, run by Universitair Ziekenhuis Brussel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
factors influencing the choice concerning breast reconstruction after mastectomy, assessed with a questionnaire (with multiple choice and open questions) (time frame: december 2016 - may 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03039348, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.