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Emotional Evaluation and Reconstructed Breast Satisfaction

Primary Purpose

Malignant Neoplasm of the Breast

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
First Questionnaire application
Second Questionnaire application
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Malignant Neoplasm of the Breast focused on measuring breast cancer, breast surgery, breast reconstruction,

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital das Clínicas de Ribeirão Preto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pre-surgery First Breast Q

Post-surgery Second Breast Q

Arm Description

Women with proven breast cancer diagnosis. Respond to the First Breast Q questionnaire..

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
December 14, 2018
Last Updated
April 15, 2019
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03777852
Brief Title
Emotional Evaluation and Reconstructed Breast Satisfaction
Official Title
Emotional Evaluation and Reconstructed Breast Satisfaction After Breast Cancer Treatment: Breast Q Questionary
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Anticipated)
Primary Completion Date
February 28, 2021 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Neoplasm of the Breast
Keywords
breast cancer, breast surgery, breast reconstruction,

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Non-Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre-surgery First Breast Q
Arm Type
Experimental
Arm Description
Women with proven breast cancer diagnosis. Respond to the First Breast Q questionnaire..
Arm Title
Post-surgery Second Breast Q
Arm Type
Active Comparator
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
First Questionnaire application
Other Intervention Name(s)
First Breast Q questionnaire
Intervention Description
Women with breast cancer will respond to the First Breast Q questionnaire before treatment with breast cancer reconstruction surgery.
Intervention Type
Diagnostic Test
Intervention Name(s)
Second Questionnaire application
Other Intervention Name(s)
Post reconstruction breast cancer
Intervention Description
Women with breast cancer will respond to the Second Breast Q questionnaire after treatment with breast cancer reconstruction surgery.
Primary Outcome Measure Information:
Title
Post-treatment Satisfaction
Description
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).
Time Frame
Six month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helio HA Carrara, MD, PhD
Phone
551636021000
Ext
2589
Email
carrara@fmrp.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Francisco JC Reis, MD, PhD
Phone
551636022589
Email
fjcreis@fmrp.usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helio HA Carrara, MD, PhD
Organizational Affiliation
Gynecology & Obstetrics Departament, Ribeirão Preto Medical School, USP.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas de Ribeirão Preto
City
Ribeirão Preto
State/Province
SP
ZIP/Postal Code
14048900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26740288
Citation
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.
Results Reference
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PubMed Identifier
19644246
Citation
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.
Results Reference
background
PubMed Identifier
28445351
Citation
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.
Results Reference
background
PubMed Identifier
28938344
Citation
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.
Results Reference
background
PubMed Identifier
27179527
Citation
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.
Results Reference
background
PubMed Identifier
28279888
Citation
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.
Results Reference
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Emotional Evaluation and Reconstructed Breast Satisfaction

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