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

NCT05054777 | Unknown

• 1 other identifier: ShandongCHI-18
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Patient Reported Outcome; Oncological Safety; Breast-conserving Surgery; Breast Cancer Female

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (3)

• Complication's ratio

  up to 24 months

• Cosmetic results

  Change from baseline at 1 year and 2 years post-operatively

• Overall survival

  up to 24 months

Study Arms (2)

oncoplastic breast-conserving surgery

The oncoplastic breast-conserving surgery were mainly those surgeries using volume displacement or volume replacement techniques

Procedure: oncoplastic breast-conserving surgery

conventional breast-conserving surgery

The conventional breast-conserving surgery were performed without any oncoplastic operations

Procedure: conventional breast-conserving surgery

Interventions

oncoplastic breast-conserving surgery PROCEDURE

The patients received oncoplastic breast-conserving surgery, including volume displacement or volume replacement techniques

oncoplastic breast-conserving surgery

conventional breast-conserving surgery PROCEDURE

conventional breast-conserving surgery without any oncoplastic operations

conventional breast-conserving surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: famale
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non-metastatic breast cancer patients received surgical treatment in the hospital. The patients must fulfill indications of breast cancer surgery according to NCCN clinical guidelines, and do not have any absolute contraindications.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Related 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.

  PMID: 28214053 BACKGROUND

Central Study Contacts

Chao Li, MD

CONTACT

008615665851082; lichao19890305@126.com

Zhiyong Yu, PhD

CONTACT

008613355312277; drzhiyongyu@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 23, 2021
• Study Start: October 1, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: September 23, 2021

Record last verified: 2021-09