Clinical trial · Observational

Patient Reported Outcomes After Oncoplastic Breast Conserving Surgery

NCT05724758CI-TRIAL-00063874unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer in Situ	Breast Carcinoma In Situ	ALIAS	0.90
Breast Cancer Stage I	Malignant Breast Neoplasm	CURATED_BROADER	0.78
Breast Cancer Stage II	Malignant Breast Neoplasm	CURATED_BROADER	0.78

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Breast-conserving surgery	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (2)

measure
Change of patient satisfaction with their breasts pre- and post breast-conserving surgery
timeFrame
before the surgery and 4 weeks after the surgery
description
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.
measure
Change of quality of Life pre- and post breast-conserving surgery
timeFrame
before the surgery and 4 weeks after the surgery
description
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.

Secondary outcomes (1)

measure
impact of age (>70 and < 60 years old) on Patient reported outcome measures
timeFrame
baseline and 4 weeks postoperative

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* BCT oncoplastic surgery technique
* Women \> 18 years

Exclusion Criteria:

* 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)

References

Publications (17)

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BACKGROUNDWorld Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available. PMID 24141714
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BACKGROUNDMcIntosh J, O'Donoghue JM. Therapeutic mammaplasty--a systematic review of the evidence. Eur J Surg Oncol. 2012 Mar;38(3):196-202. doi: 10.1016/j.ejso.2011.12.004. Epub 2011 Dec 27. PMID 22206704
BACKGROUNDCarter 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. PMID 27406093
BACKGROUNDRose M, Manjer J, Ringberg A, Svensson H. Surgical strategy, methods of reconstruction, surgical margins and postoperative complications in oncoplastic breast surgery. Eur J Plast Surg. 2014;37(4):205-214. doi: 10.1007/s00238-013-0922-4. Epub 2014 Feb 1. PMID 24659858