MammaplastySQUARENCT04329819
Satisfaction and QUality of Life After Breast REconstruction
An observational study of Mammaplasty and Breast Neoplasm Female, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial summary
Breast cancer is the most common cancer in women in France in term of repercussion, 58 698 people has been diagnosed in 2017. Breast cancer is often with good prognosis. The 5 years disease-free survival rate is 87%. Surgery has a major place in breast cancer treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mammaplasty, Breast Neoplasm Female
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2019to 25 Nov 2019
- 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 who had finished the breast reconstruction immediate or differed between 01/01/2015 and 31/12/16 whatever the technic used, following the mastectomy for breast cancer at the Institut de Cancerologie de l'Ouest, site Saint-Herblain
Who may be able to join
- Patients 18 years old or more
- History of mastectomy for breast cancer all types and TNM status
- Patients who beneficiated a breast reconstruction immediate or secondary finished between 01/01/2015 and 31/12/16 (not included nipples)
- Accept to answer to the questionnaire
Who cannot join
- Deceased patient
- Opposition of the patient to the data collection
- History of preventive mastectomy
- Patient who has local recurrence or metastatic cancer
- Patient under guardianship or protection of vulnerable adults
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Satisfaction and the Quality of Life of Patients After Breast Reconstruction as Part of Breast Cancer. Comparison of Several Technics.
Breast cancer is the most common cancer in women in France in term of repercussion, 58 698 people has been diagnosed in 2017. Breast cancer is often with good prognosis. The 5 years disease-free survival rate is 87%. Surgery has a major place in breast cancer treatment. Although the conservative surgery is preferred, it stays the indication of mastectomy for nearly 30% of cases. This radical surgery is often experienced by the patient as a mutilation with the impact that this entails from a psychological point of view but also on the quality of life. Breast reconstruction allows an improvement of quality of life with a better acceptance of the body scheme and the benefits in the psychological and sexual domains. The reconstruction is an integral part of the therapeutic care; however, it is not done systematically. Indeed, in France nearly 35% of patients benefit of breast reconstruction 5 years after the mastectomy.
Nowadays, several surgical technics are available to do the reconstruction: autologous technics and the reconstruction with implants. It can be differed or immediate. The strategy of reconstruction is established in accordance with many parameters: the morphology of the breast and of the patient, the state of the thoracic wall and history of radiotherapy, comorbidities, contraindication and of course the wish of the patient. According to the used technics, the reconstruction can sometimes extend to several months, especially for the exclusive fat reshaping which needs a lot of surgery. The autologous technics seems to give a better satisfaction to the patients in an esthetical point of view but we do not have many data including the fat reshaping.
Read more
Among the tests allowing the evaluation of quality of life of patients, the Breast-Q© is a self-questionnaire validated that is specific to the breast surgery and includes a module concerning the breast reconstruction. It allows evaluating the quality of life (physical, psychosocial and sexual well-being) and the satisfaction of patients (based on cosmetic results and the care). The reconstruction module includes 116 items in its post-surgery version and is adapted to different types of reconstruction.
The objective of our project is to evaluate the quality of life and the satisfaction of patients having an immediate or differed breast reconstruction according to the technics used, with the help of the validated questionnaire Breast-Q© and the additional questionnaires.
Read the detailed description
This study is retrospective and compared including exhaustively all the patients answering all inclusion criteria. The list of patients answering to all inclusion criteria will be collected with the help of the medical information department. Based on a screening on the aggregated data of the centre, the size of the sample is around 300 patients.
The medics will inform the eligible patients of the study with the help of the information note by letter. The patient will be informed of the objective if the study, the treatment of the informatics data collected during this study and the access right, the rectification, the effacement, the limit of the data treatment, the portability and opposition. This right can be done whenever to the delegate of the Data Protection.
The information letter with questionnaires will be send by post to the selected patient house. The patient responding to the questionnaires will be included in the study. In this way a part of the data will be collected directly from the answer communicated by the patient through the Breast-Q©.
Additional data will be collected in an indirect way from elements available from the informatics clinic medical file. The clinicians of the centre could be ask to complete the information.
- Conditions
- Mammaplasty, Breast Neoplasm Female
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the quality of life and the satisfaction of patients who had a breast reconstruction immediate or differed according to the technics used
The evaluation will be done through the BREAST-Q© questionnaire (module of reconstruction and post-surgery version) The quality of life is evaluated through 6 scales (psychological and sexual well-being and also physical well-being: breast, abdomen/trunk, shoulder/back). The satisfaction is evaluated with 9 scales (satisfaction of breast, nipples, abdomen, back and treatment: information received, surgeon, medical team and administrative staff).
There is no global score for BREAST- Q©. Each scale is independent and converted from 0 to 100. A high score means a better satisfaction of quality of life.
Measured: 2 months
Secondary outcomes (1)
Describe the practices in term of breast reconstruction in the Institut de Cancerologie de l'Ouest-site Saint-Herblain.
The frequency of different technics used in the ICO site Saint-Herblain will be documented.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start3 Sep 2019
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MammaplastyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victoire BRILLAUD-MEFLAH, Principal investigator, Institut de Cancerologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329819
- Sponsor's protocol ID
- ICO-2019-16
- Acronym
- SQUARE
- Status last verified
- Mar 2020
- First submitted
- 30 Mar 2020
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Satisfaction and the Quality of Life of Patients After Breast Reconstruction as Part of Breast Cancer. Comparison of Several Technics.
- ClinicalTrials.gov ID
- NCT04329819
- Acronym / sponsor ID
- SQUARE / ICO-2019-16
- Conditions
- Mammaplasty, Breast Neoplasm Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 1 Apr 2020 (actual)
- 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.
Breast cancer is the most common cancer in women in France in term of repercussion, 58 698 people has been diagnosed in 2017. Breast cancer is often with good prognosis. The 5 years disease-free survival rate is 87%. Surgery has a major place in breast cancer treatment. Although the conservative surgery is preferred, it stays the indication of mastectomy for nearly 30% of cases. This radical surgery is often experienced by the patient as a mutilation with the impact that this entails from a psychological point of view but also on the quality of life. Breast reconstruction allows an improvement of quality of life with a better acceptance of the body scheme and the benefits in the psychological and sexual domains. The reconstruction is an integral part of the therapeutic care; however, it is not done systematically. Indeed, in France nearly 35% of patients benefit of breast reconstruction 5 years after the mastectomy.
Nowadays, several surgical technics are available to do the reconstruction: autologous technics and the reconstruction with implants. It can be differed or immediate. The strategy of reconstruction is established in accordance with many parameters: the morphology of the breast and of the patient, the state of the thoracic wall and history of radiotherapy, comorbidities, contraindication and of course the wish of the patient. According to the used technics, the reconstruction can sometimes extend to several months, especially for the exclusive fat reshaping which needs a lot of surgery. The autologous technics seems to give a better satisfaction to the patients in an esthetical point of view but we do not have many data including the fat reshaping.
Among the tests allowing the evaluation of quality of life of patients, the Breast-Q© is a self-questionnaire validated that is specific to the breast surgery and includes a module concerning the breast reconstruction. It allows evaluating the quality of life (physical, psychosocial and sexual well-being) and the satisfaction of patients (based on cosmetic results and the care). The reconstruction module includes 116 items in its post-surgery version and is adapted to different types of reconstruction.
The objective of our project is to evaluate the quality of life and the satisfaction of patients having an immediate or differed breast reconstruction according to the technics used, with the help of the validated questionnaire Breast-Q© and the additional questionnaires.
Detailed description
This study is retrospective and compared including exhaustively all the patients answering all inclusion criteria. The list of patients answering to all inclusion criteria will be collected with the help of the medical information department. Based on a screening on the aggregated data of the centre, the size of the sample is around 300 patients.
The medics will inform the eligible patients of the study with the help of the information note by letter. The patient will be informed of the objective if the study, the treatment of the informatics data collected during this study and the access right, the rectification, the effacement, the limit of the data treatment, the portability and opposition. This right can be done whenever to the delegate of the Data Protection.
The information letter with questionnaires will be send by post to the selected patient house. The patient responding to the questionnaires will be included in the study. In this way a part of the data will be collected directly from the answer communicated by the patient through the Breast-Q©.
Additional data will be collected in an indirect way from elements available from the informatics clinic medical file. The clinicians of the centre could be ask to complete the information.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had finished the breast reconstruction immediate or differed between 01/01/2015 and 31/12/16 whatever the technic used, following the mastectomy for breast cancer at the Institut de Cancerologie de l'Ouest, site Saint-Herblain
Key inclusion criteria (4 listed)
- Patients 18 years old or more
- History of mastectomy for breast cancer all types and TNM status
- Patients who beneficiated a breast reconstruction immediate or secondary finished between 01/01/2015 and 31/12/16 (not included nipples)
- Accept to answer to the questionnaire
Key exclusion criteria (5 listed)
- Deceased patient
- Opposition of the patient to the data collection
- History of preventive mastectomy
- Patient who has local recurrence or metastatic cancer
- Patient under guardianship or protection of vulnerable adults
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the quality of life and the satisfaction of patients who had a breast reconstruction immediate or differed according to the technics used
Time frame: 2 months
The evaluation will be done through the BREAST-Q© questionnaire (module of reconstruction and post-surgery version) The quality of life is evaluated through 6 scales (psychological and sexual well-being and also physical well-being: breast, abdomen/trunk, shoulder/back). The satisfaction is evaluated with 9 scales (satisfaction of breast, nipples, abdomen, back and treatment: information received, surgeon, medical team and administrative staff). There is no global score for BREAST- Q©. Each scale is independent and converted from 0 to 100. A high score means a better satisfaction of quality of life.
1 secondary outcome
Describe the practices in term of breast reconstruction in the Institut de Cancerologie de l'Ouest-site Saint-Herblain.
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
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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.
Victoire BRILLAUD-MEFLAH principal investigator
Institut de Cancerologie de l'Ouest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mammaplasty and Breast Neoplasm Female, run by Institut Cancerologie de l'Ouest at 1 site in France.
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 5 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: finished, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate the quality of life and the satisfaction of patients who had a breast reconstruction immediate or differed according to the technics used (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2020.