Clinical trial · Observational

Patient Report Outcome and Oncological Safety -Oncoplastic and Conventional BCS Cohort

Chinese Multicenter Prospective Registry of Breast Cancer Patient Reported Outcome and Oncological Safety -Oncoplastic and Conventional BCS Cohort

NCT05054777CI-TRIAL-00054044unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Breast-conserving surgery (BCS) is the traditional surgical treatment for early-stage breast cancer patients. There are evidences indicating that oncoplastic BCS could improve cosmetic outcomes and/or quality of life, and has similar oncological safety as conventional BCS does. However, these studies that focused on patient-reported outcomes and oncological safety were mainly from one institution or of small sample size. The variations across hospitals and regions were not fully analyzed. A multicenter prospective patient report outcome (PROs) and oncological safety will be planned to assess the PROs and safety for Chinese breast cancer patients who will undergo oncoplastic and conventional breast-conserving surgery (OBCS). This study follows the Helsinki Declaration and Chinese rules. All patients will be asked to sign the informed consent and will be followed up 24 months after operations. All data will be collected.

Conditions

Conditions (4)

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 Female	—	UNRESOLVED	—
Breast-conserving Surgery	—	UNRESOLVED	—
Oncological Safety	—	UNRESOLVED	—
Patient Reported Outcome	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
conventional breast-conserving surgery	Procedure	—	UNRESOLVED
oncoplastic breast-conserving surgery	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

label
oncoplastic breast-conserving surgery
description
The oncoplastic breast-conserving surgery were mainly those surgeries using volume displacement or volume replacement techniques
interventionNames
1. Procedure: oncoplastic breast-conserving surgery
label
conventional breast-conserving surgery
description
The conventional breast-conserving surgery were performed without any oncoplastic operations
interventionNames
1. Procedure: conventional breast-conserving surgery

Primary outcomes (4)

measure
Patients' satisfaction：BREAST-Q score
timeFrame
Change from baseline at 6 months, 1 year and 2 years post-operatively
description
The Breast-Q© is a patient reported outcome measure (PROM) for breast surgery that was rigorously developed to accurately measure patient reported satisfaction and quality of life (QOL). (http://www.mskcc.org/mskcc/shared/Breast-Q/index.html). The BREAST-Q was developed and validated with adherence to international guidelines. This PROM is composed of six scales that address: 1) psychosocial well-being, 2) physical well-being, 3) sexual well-being, 4) satisfaction with breasts, 5) satisfaction with outcome, and 6) satisfaction with care. Each module generates a Q-score on a 0-100 scale that can be used for quantitative analysis to enable statistical comparison of the pre- to the post-operative state.

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years

Show eligibility criteria text

Inclusion Criteria:

1. Informed consent signed;
2. Non-metastatic Breast cancer patients confirmed by pathology;
3. Adult (\>18 years old, \<80 years old);
4. Female;
5. Must undergo oncoplastic or conventional breast-conserving surgery;

Exclusion Criteria:

1. Inflammatory breast cancer, Stage IV breast cancer patients;
2. Have other malignant tumors;
3. Pregnancy women;
4. Have severe co-morbidities that compromise the patients' compliance to our protocol, or endanger the patients;
5. Refuse breast-conserving surgery.

References

Publications (1)

BACKGROUNDWeber WP, Soysal SD, Fulco I, Barandun M, Babst D, Kalbermatten D, Schaefer DJ, Oertli D, Kappos EA, Haug M. Standardization of oncoplastic breast conserving surgery. Eur J Surg Oncol. 2017 Jul;43(7):1236-1243. doi: 10.1016/j.ejso.2017.01.006. Epub 2017 Jan 31. PMID 28214053