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

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05054777
• Other study ID #: ShandongCHI-18
• Status: Not yet recruiting
• Start date: October 1, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: September 2021
• Source: Shandong Cancer Hospital and Institute
• Contact: Chao Li, MD
• Phone: 008615665851082
• Email: lichao19890305[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Breast-conserving Surgery
• Patient Reported Outcome

Intervention

Procedure:
• oncoplastic breast-conserving surgery
The patients received oncoplastic breast-conserving surgery, including volume displacement or volume replacement techniques
• conventional breast-conserving surgery
conventional breast-conserving surgery without any oncoplastic operations

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

References & Publications (1)

Weber 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients' satisfaction:BREAST-Q score	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.	Change from baseline at 6 months, 1 year and 2 years post-operatively
Primary	EORTC QLQ-C30	The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome.	Change from baseline at 1 year and 2 years post-operatively
Primary	Health-related quality of life:EORTC QLQ-BR23	EORTC QLQ-BR-23 consists of 23 questions related to breast cancer. The questionnaire will be self-administered and will be given in patient's mother tongue. EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems.	Change from baseline at 1 year and 2 years post-operatively
Primary	Recurrence-free survival	Recurrence-free survival (RFS) was calculated as time from breast cancer diagnosis until locoregional (LRRFS) or distant recurrence (DRFS) or death due to breast cancer, whichever came first	up to 24 months
Secondary	Complication's ratio	Postoperative complications were classified following Clavien-Dindo Classification. Grade I complication (light inflammations, non-surgical haematoma or suffusion, seroma formation, partial skin/NAC loss, limited fat necrosis, SSI and lymphoedema) does not require medication or surgical treatment. Grade II complication is a Grade I complication that requires medication or surgical interaction (antibiotic therapy, resuture due SSI and multiple puncture due chronic seroma). Grade III complication requires invasive surgical action (haematoma evacuation, chronic inflammation which requires reoperation, severe fat necrosis, full skin/ NAC necrosis and wound dehiscense). Grade IV complication means temporary organ failure. Grade V complication is one that leads to death	up to 24 months
Secondary	Cosmetic results	The primary aesthetic stage will be documented with standard photo documentation using valid BCCT. core software making it measurable which allows us to compare it. the photo documentation performed the standard way in 5 position (antero-posterior (ap), 45 degree oblique and 90 degree lateral), in ap direction both ways arms up and down with strict adherence to personal privacy policies. The mentioned software counts measurements regarding to the photo documentation and gives a 4-point rating scale (1: excellent, 2: good, 3: acceptable, 4: non-acceptable). These numerical results can be statistically analyzed. We use the Likert scale (1. definitely not, 2: no, 3: abstain, 4: agree, 4: definitely agree) for evaluating the subjective aesthetic outcome based on the photo documentation (preoperative, postoperative 4-6th weeks, 3rd months, every 6 months 5 years long). The results are collected and averaged.	Change from baseline at 1 year and 2 years post-operatively
Secondary	Overall survival	Overall survival (OS) was defined as the time from beginning treatment to the time of death from any cause or the date of last contact if death was not recorded before the cutoff date.	up to 24 months