Patient Reported Outcomes After Oncoplastic Breast Conserving Surgery

NCT05724758 | Unknown

• 1 other identifier: Patient reported outcome
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to assess patient satisfaction after oncoplastic breast conserving surgery. With the help of a breast-questionnaire the patient satisfaction will be assessed before the surgery and 4 weeks, 6 months and 1 year after the operation. The main question it aims to answer are: Does breast conserving surgery improve quality of life. type of study: cohort study, observational OCBS = oncoplastic breast conserving surgery BCT = breast conserving therapy DCIS = ductal carcinoma in situ participant population/health conditions

• Patients with newly diagnosed breast cancer, that can be treated breast conserving
• the participants have to be at least 18 years old Participants will fill out a questionnaire pre surgery, 4 weeks, 6 months and 1 year after the surgery. The individual questionnaires will be compared.

Conditions

Breast Cancer Stage I; Breast Cancer Stage II; Breast Cancer in Situ

Outcome Measures

Primary Outcomes (2)

• Change of patient satisfaction with their breasts pre- and post breast-conserving surgery

  To assess patient satisfaction using BREAST-Q over the duration of the breast cancer clinical management and follow up i.e., pre-, and postoperative: 4 weeks, 6 months and 1 year after the surgery.

  before the surgery and 4 weeks after the surgery

• Change of quality of Life pre- and post breast-conserving surgery

  To assess Quality of Life using BREAST-Q over the duration of the breast cancer clinical management and follow up i.e., pre-, and postoperative: 4 weeks, 6 months and 1 year after the surgery.

  before the surgery and 4 weeks after the surgery

Secondary Outcomes (1)

• impact of age (>70 and < 60 years old) on Patient reported outcome measures

  baseline and 4 weeks postoperative

Interventions

Breast-conserving surgery PROCEDURE

Following oncoplastic surgeries are performed at the Brust-Zentrum in Zurich: * Oncoplastic reconstruction with round-block technique * Oncoplastic reconstruction using J-Plastic * Oncoplastic reconstruction using V-Plastic * Oncoplastic reconstruction using Grisotti * Oncoplastic reconstruction using Batwing * Oncoplastic reconstruction using Mammareductionplasty (Wise Pattern, Vertical) * Oncoplastic perforator flap surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from Brust-Zentrum Zürich undergoing oncoplastic breast surgery recruited between March and September 2023

You may qualify if:

• BCT oncoplastic surgery technique
• Women \> 18 years

You may not qualify if:

• Previously treated ipsilateral breast cancer or DCIS
• Severe psychological illness by doctors' discretion (as taking part in a study could increase anxiety) or severe dementia, that stops them to consent to the procedure
• Pregnant women
• Distant metastatic disease (M1)

Sponsors & Collaborators

• Brust-Zentrum AG: lead

Related Publications (17)

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• Carter SA, Lyons GR, Kuerer HM, Bassett RL Jr, Oates S, Thompson A, Caudle AS, Mittendorf EA, Bedrosian I, Lucci A, DeSnyder SM, Babiera G, Yi M, Baumann DP, Clemens MW, Garvey PB, Hunt KK, Hwang RF. Operative and Oncologic Outcomes in 9861 Patients with Operable Breast Cancer: Single-Institution Analysis of Breast Conservation with Oncoplastic Reconstruction. Ann Surg Oncol. 2016 Oct;23(10):3190-8. doi: 10.1245/s10434-016-5407-9. Epub 2016 Jul 12.

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• Kaviani A, Sodagari N, Sheikhbahaei S, Eslami V, Hafezi-Nejad N, Safavi A, Noparast M, Fitoussi A. From radical mastectomy to breast-conserving therapy and oncoplastic breast surgery: a narrative review comparing oncological result, cosmetic outcome, quality of life, and health economy. ISRN Oncol. 2013 Sep 12;2013:742462. doi: 10.1155/2013/742462.

  PMID: 24167743 BACKGROUND

• Wijgman DJ, Ten Wolde B, van Groesen NR, Keemers-Gels ME, van den Wildenberg FJ, Strobbe LJ. Short term safety of oncoplastic breast conserving surgery for larger tumors. Eur J Surg Oncol. 2017 Apr;43(4):665-671. doi: 10.1016/j.ejso.2016.11.021. Epub 2016 Dec 18.

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  PMID: 26021789 BACKGROUND

• Cil TD, Cordeiro E. Complications of Oncoplastic Breast Surgery Involving Soft Tissue Transfer Versus Breast-Conserving Surgery: An Analysis of the NSQIP Database. Ann Surg Oncol. 2016 Oct;23(10):3266-71. doi: 10.1245/s10434-016-5477-8. Epub 2016 Aug 12.

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MeSH Terms

Conditions

Breast Neoplasms; Breast Carcinoma In Situ

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Central Study Contacts

Kavitha Däster, Dr. med.

CONTACT

+41 44 533 81 00; kavitha.daester@brust-zentrum.ch

Giada Schaber, Med. cand.

CONTACT

+41 76 346 05 26; giada.schaber@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: February 13, 2023
• Study Start: March 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: February 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share