Emotional Evaluation and Reconstructed Breast Satisfaction

NCT ID: NCT03777852

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2022-02-28

Brief Summary

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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

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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

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Malignant Neoplasm of the Breast

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

A group of women will be evaluated twice, being one before the intervention and the second after the breast cancer reconstruction surgery
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Pre-surgery First Breast Q

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

Group Type EXPERIMENTAL

First Questionnaire application

Intervention Type DIAGNOSTIC_TEST

Women with breast cancer will respond to the First Breast Q questionnaire before treatment with breast cancer reconstruction surgery.

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.

Group Type ACTIVE_COMPARATOR

Second Questionnaire application

Intervention Type DIAGNOSTIC_TEST

Women with breast cancer will respond to the Second Breast Q questionnaire after treatment with breast cancer reconstruction surgery.

Interventions

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First Questionnaire application

Women with breast cancer will respond to the First Breast Q questionnaire before treatment with breast cancer reconstruction surgery.

Intervention Type DIAGNOSTIC_TEST

Second Questionnaire application

Women with breast cancer will respond to the Second Breast Q questionnaire after treatment with breast cancer reconstruction surgery.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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First Breast Q questionnaire Post reconstruction breast cancer

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Helio Carrara

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helio HA Carrara, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Gynecology & Obstetrics Departament, Ribeirão Preto Medical School, USP.

Locations

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Hospital das Clínicas de Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Helio HA Carrara, MD, PhD

Role: CONTACT

551636021000 ext. 2589

Francisco JC Reis, MD, PhD

Role: CONTACT

551636022589

References

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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.

Reference Type BACKGROUND
PMID: 26740288 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19644246 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28445351 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28938344 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27179527 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28279888 (View on PubMed)

Other Identifiers

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Helio Carrara

Identifier Type: OTHER

Identifier Source: secondary_id

Juçara Phd Thesis

Identifier Type: -

Identifier Source: org_study_id

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