Emotional Evaluation and Reconstructed Breast Satisfaction

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.

Study Overview

• Status: Unknown
• Conditions: Malignant Neoplasm of the Breast
• Intervention / Treatment: Diagnostic test: First Questionnaire application; Diagnostic test: Second Questionnaire application

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 Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helio HA Carrara, MD, PhD; Phone Number: 2589 551636021000; Email: carrara@fmrp.usp.br
• Study Contact Backup: Name: Francisco JC Reis, MD, PhD; Phone Number: 551636022589; Email: fjcreis@fmrp.usp.br

Study Locations

• Brazil
  • SP
    • Ribeirão Preto, SP, Brazil, 14048900
      • Hospital das Clínicas de Ribeirão Preto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-surgery First Breast Q; Women with proven breast cancer diagnosis. Respond to the First Breast Q questionnaire..	Diagnostic test: First Questionnaire application; Women with breast cancer will respond to the First Breast Q questionnaire before treatment with breast cancer reconstruction surgery.; Other Names: First Breast Q questionnaire
Active Comparator: Post-surgery Second Breast Q; 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.	Diagnostic test: Second Questionnaire application; Women with breast cancer will respond to the Second Breast Q questionnaire after treatment with breast cancer reconstruction surgery.; Other Names: Post reconstruction breast cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Six month

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Helio HA Carrara, MD, PhD, Gynecology & Obstetrics Departament, Ribeirão Preto Medical School, USP.

Publications and helpful links

General Publications

• Pusic 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.
• Mundy 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.
• 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.
• Payne 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.
• Saiga 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.
• Fuzesi 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2019
• Primary Completion (Anticipated): February 28, 2021
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: December 14, 2018
• First Submitted That Met QC Criteria: December 14, 2018
• First Posted (Actual): December 17, 2018

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: breast cancer, breast surgery, breast reconstruction,
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Site; Breast Diseases; Neoplasms; Breast Neoplasms
• Other Study ID Numbers: Juçara Phd Thesis; Helio Carrara (Other Identifier: DGO-FMRP-USP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No