Clinical trial · Interventional
Emotional Evaluation and Reconstructed Breast Satisfaction
Emotional Evaluation and Reconstructed Breast Satisfaction After Breast Cancer Treatment: Breast Q Questionary
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm of the Breast | Malignant Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| First Questionnaire application | Diagnostic Test | — | UNRESOLVED |
| Second Questionnaire application | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pre-surgery First Breast Q
- description
- Women with proven breast cancer diagnosis. Respond to the First Breast Q questionnaire..
- interventionNames
- Diagnostic Test: First Questionnaire application
- type
- ACTIVE_COMPARATOR
- label
- Post-surgery Second Breast Q
- description
- 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.
- interventionNames
- Diagnostic Test: Second Questionnaire application
Primary outcomes (1)
- measure
- Post-treatment Satisfaction
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (6)
- BACKGROUNDCohen 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. PMID 26740288
- BACKGROUNDPusic 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. PMID 19644246
- BACKGROUNDMundy 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. PMID 28445351
- BACKGROUNDPayne 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. PMID 28938344
- BACKGROUNDSaiga 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. PMID 27179527
- BACKGROUNDFuzesi 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. PMID 28279888