Malignant Neoplasm of the BreastNCT03777852
Emotional Evaluation and Reconstructed Breast Satisfaction
A study testing First Questionnaire application and Second Questionnaire application in people with Malignant Neoplasm of the Breast, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Data from the National Cancer Institute (Inca) reveal that breast cancer is the most common type of cancer among women worldwide. In Brazil, it is second only to non-melanoma skin cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Malignant Neoplasm of the Breast
- What is being tested?
- First Questionnaire application and Second Questionnaire application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2019to 28 Feb 2022
- Phase
- Interventional
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women over eighteen years of age;
- women with proven histological diagnosis of breast cancer;
- women who have an indication of mastectomy as part of their treatment;
- women who have breast reconstruction, regardless of the technique used, as part of their treatment;
- women under 70 years of age at the time of the reconstructive surgery
Who cannot join
- women diagnosed with breast cancer and treated with conservative surgeries;
- women who refuse reconstruction as part of treatment;
- women who refused surgery as part of the treatment for breast cancer
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas de Ribeirão Preto
Ribeirão Preto, São Paulo, 14048900
About this study
Official title: Emotional Evaluation and Reconstructed Breast Satisfaction After Breast Cancer Treatment: Breast Q Questionary
Data from the National Cancer Institute (Inca) reveal that breast cancer is the most common type of cancer among women worldwide. In Brazil, it is second only to non-melanoma skin cancer. Breast cancer is a feared disease in the female universe because it is considered one of the major causes of death due to neoplasia among women. It brings also the stigma of suffering, mutilation, loss of female identity and loss of body contour. Among other issues, problems with body self-image may have an impact on sexuality and fertility, and also, the incapacity to breastfeed. Breast reconstruction can restore the patient's shape and physical integrity, among other benefits. The research justifies itself because information about the satisfaction of breast reconstruction can be achieved. It is also known that women having breast reconstruction after a mastectomy due to cancer have a favorable evolution. This study will analyze body contour satisfaction of women undergoing mastectomy and breast reconstruction as part of their breast cancer treatment. The Breast Q questionnaire will be used to measure patients satisfaction.
Read the detailed description
This is a prospective, quasi-experimental study. The subject sample will be composed of women submitted to mastectomy due to breast cancer and to breast reconstruction as part of their treatment. They will be evaluated twice. One when they receive the cancer diagnosis and the other six months after de reconstruction surgery. On both occasions, they will answer the Brest Q questionnaire.
- Conditions
- Malignant Neoplasm of the Breast
- Being tested
- First Questionnaire application, Second Questionnaire application
- Keywords
- breast cancer, breast surgery, breast reconstruction,
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First Questionnaire applicationDiagnostic test
Also called First Breast Q questionnaire
Women with breast cancer will respond to the First Breast Q questionnaire before treatment with breast cancer reconstruction surgery.
Second Questionnaire applicationDiagnostic test
Also called Post reconstruction breast cancer
Women with breast cancer will respond to the Second Breast Q questionnaire after treatment with breast cancer reconstruction surgery.
| Study group | Role | What they receive |
|---|---|---|
| Pre-surgery First Breast Q | Experimental | Women with proven breast cancer diagnosis. Respond to the First Breast Q questionnaire.. Receives: Diagnostic Test: First Questionnaire application |
| Post-surgery Second Breast Q | Active comparator | The Second Breast Q questionnaire will be applied to this group that will be composed of the women of the first group submitted to reconstructive breast cancer surgery. Receives: Diagnostic Test: Second Questionnaire application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-treatment Satisfaction
Comparison of results between the first and the second Breast Q score. This score represents questionnaries about diferents domains and each question has four possible dimensions. The values of these dimensions varies from 1 to 4 (Likert Scale). The sum of each domain raw score scale will be plotted in the Breast Q Conversion Table to convert the summed domain score to a Equivalent Rasch Transformed Score with values ranging from 0 (worst) to 100 (best).
Measured: Six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start1 Jul 2019 (estimated)
- Primary completion28 Feb 2021 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Malignant Neoplasm of the BreastStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A group of women will be evaluated twice, being one before the intervention and the second after the breast cancer reconstruction surgery
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helio Carrara, University of Sao Paulo
- Investigators
- Helio HA Carrara, MD, PhD, Principal investigator, Gynecology & Obstetrics Departament, Ribeirão Preto Medical School, USP.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777852
- Sponsor's protocol ID
- Juçara Phd Thesis
- Other IDs
- Helio Carrara
- Status last verified
- Dec 2018
- First submitted
- 14 Dec 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cohen WA, Mundy LR, Ballard TN, Klassen A, Cano SJ, Browne J, Pusic AL. The BREAST-Q in surgical research: A review of the literature 2009-2015. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):149-62. doi: 10.1016/j.bjps.2015.11.013. Epub 2015 Nov 26.
PubMed 26740288Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807.
PubMed 19644246Mundy LR, Homa K, Klassen AF, Pusic AL, Kerrigan CL. Breast Cancer and Reconstruction: Normative Data for Interpreting the BREAST-Q. Plast Reconstr Surg. 2017 May;139(5):1046e-1055e. doi: 10.1097/PRS.0000000000003241.
PubMed 28445351Payne RM, Siotos C, Manahan MA, Rosson GD, Cooney CM. Breast Cancer and Reconstruction: Normative Data for Interpreting the BREAST-Q. Plast Reconstr Surg. 2018 Jan;141(1):180e-181e. doi: 10.1097/PRS.0000000000003970. No abstract available.
PubMed 28938344Saiga M, Taira N, Kimata Y, Watanabe S, Mukai Y, Shimozuma K, Mizoo T, Nogami T, Iwamoto T, Motoki T, Shien T, Matsuoka J, Doihara H. Development of a Japanese version of the BREAST-Q and the traditional psychometric test of the mastectomy module for the assessment of HRQOL and patient satisfaction following breast surgery. Breast Cancer. 2017 Mar;24(2):288-298. doi: 10.1007/s12282-016-0703-6. Epub 2016 May 14.
PubMed 27179527Fuzesi S, Cano SJ, Klassen AF, Atisha D, Pusic AL. Validation of the electronic version of the BREAST-Q in the army of women study. Breast. 2017 Jun;33:44-49. doi: 10.1016/j.breast.2017.02.015. Epub 2017 Mar 7.
PubMed 28279888
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Evaluation and Reconstructed Breast Satisfaction After Breast Cancer Treatment: Breast Q Questionary
- ClinicalTrials.gov ID
- NCT03777852
- Acronym / sponsor ID
- Juçara Phd Thesis
- Conditions
- Malignant Neoplasm of the Breast
- Keywords
- breast cancer, breast surgery, breast reconstruction,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 17 Dec 2018 (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.
Data from the National Cancer Institute (Inca) reveal that breast cancer is the most common type of cancer among women worldwide. In Brazil, it is second only to non-melanoma skin cancer. Breast cancer is a feared disease in the female universe because it is considered one of the major causes of death due to neoplasia among women. It brings also the stigma of suffering, mutilation, loss of female identity and loss of body contour. Among other issues, problems with body self-image may have an impact on sexuality and fertility, and also, the incapacity to breastfeed. Breast reconstruction can restore the patient's shape and physical integrity, among other benefits. The research justifies itself because information about the satisfaction of breast reconstruction can be achieved. It is also known that women having breast reconstruction after a mastectomy due to cancer have a favorable evolution. This study will analyze body contour satisfaction of women undergoing mastectomy and breast reconstruction as part of their breast cancer treatment. The Breast Q questionnaire will be used to measure patients satisfaction.
Detailed description
This is a prospective, quasi-experimental study. The subject sample will be composed of women submitted to mastectomy due to breast cancer and to breast reconstruction as part of their treatment. They will be evaluated twice. One when they receive the cancer diagnosis and the other six months after de reconstruction surgery. On both occasions, they will answer the Brest Q questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A group of women will be evaluated twice, being one before the intervention and the second after the breast cancer reconstruction surgery
| Arm | Type | Receives |
|---|---|---|
| Pre-surgery First Breast Q | Experimental | Diagnostic Test: First Questionnaire applicationWomen with proven breast cancer diagnosis. Respond to the First Breast Q questionnaire.. |
| Post-surgery Second Breast Q | Active comparator | Diagnostic Test: Second Questionnaire applicationThe Second Breast Q questionnaire will be applied to this group that will be composed of the women of the first group submitted to reconstructive breast cancer surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- women over eighteen years of age;
- women with proven histological diagnosis of breast cancer;
- women who have an indication of mastectomy as part of their treatment;
- women who have breast reconstruction, regardless of the technique used, as part of their treatment;
- women under 70 years of age at the time of the reconstructive surgery
Key exclusion criteria (3 listed)
- women diagnosed with breast cancer and treated with conservative surgeries;
- women who refuse reconstruction as part of treatment;
- women who refused surgery as part of the treatment for breast cancer
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 |
|---|---|---|
| First Questionnaire applicationAlso: First Breast Q questionnaireWomen with breast cancer will respond to the First Breast Q questionnaire before treatment with breast cancer reconstruction surgery. | Diagnostic test | Pre-surgery First Breast Q |
| Second Questionnaire applicationAlso: Post reconstruction breast cancerWomen with breast cancer will respond to the Second Breast Q questionnaire after treatment with breast cancer reconstruction surgery. | Diagnostic test | Post-surgery Second Breast Q |
Primary outcome
Post-treatment Satisfaction
Time frame: Six month
Comparison of results between the first and the second Breast Q score. This score represents questionnaries about diferents domains and each question has four possible dimensions. The values of these dimensions varies from 1 to 4 (Likert Scale). The sum of each domain raw score scale will be plotted in the Breast Q Conversion Table to convert the summed domain score to a Equivalent Rasch Transformed Score with values ranging from 0 (worst) to 100 (best).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Background: PubMed 26740288Cohen WA, Mundy LR, Ballard TN, Klassen A, Cano SJ, Browne J, Pusic AL. The BREAST-Q in surgical research: A review of the literature 2009-2015. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):149-62. doi: 10.1016/j.bjps.2015.11.013. Epub 2015 Nov 26.
- Background: PubMed 19644246Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807.
- Background: PubMed 28445351Mundy LR, Homa K, Klassen AF, Pusic AL, Kerrigan CL. Breast Cancer and Reconstruction: Normative Data for Interpreting the BREAST-Q. Plast Reconstr Surg. 2017 May;139(5):1046e-1055e. doi: 10.1097/PRS.0000000000003241.
- Background: PubMed 28938344Payne RM, Siotos C, Manahan MA, Rosson GD, Cooney CM. Breast Cancer and Reconstruction: Normative Data for Interpreting the BREAST-Q. Plast Reconstr Surg. 2018 Jan;141(1):180e-181e. doi: 10.1097/PRS.0000000000003970. No abstract available.
- Background: PubMed 27179527Saiga M, Taira N, Kimata Y, Watanabe S, Mukai Y, Shimozuma K, Mizoo T, Nogami T, Iwamoto T, Motoki T, Shien T, Matsuoka J, Doihara H. Development of a Japanese version of the BREAST-Q and the traditional psychometric test of the mastectomy module for the assessment of HRQOL and patient satisfaction following breast surgery. Breast Cancer. 2017 Mar;24(2):288-298. doi: 10.1007/s12282-016-0703-6. Epub 2016 May 14.
- Background: PubMed 28279888Fuzesi S, Cano SJ, Klassen AF, Atisha D, Pusic AL. Validation of the electronic version of the BREAST-Q in the army of women study. Breast. 2017 Jun;33:44-49. doi: 10.1016/j.breast.2017.02.015. Epub 2017 Mar 7.
- Individual participant dataSharing planned: No
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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.
Helio HA Carrara, MD, PhD principal investigator
Gynecology & Obstetrics Departament, Ribeirão Preto Medical School, USP.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First Questionnaire application and Second Questionnaire application in people with Malignant Neoplasm of the Breast, run by University of Sao Paulo at 1 site in Brazil.
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 5 inclusion and 3 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 16 Apr 2019. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helio HA Carrara, MD, PhD (551636021000 ext. 2589, carrara@fmrp.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-treatment Satisfaction (time frame: Six month). 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 NCT03777852, which also lists 6 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 16 Apr 2019.