Patient Report Outcome-Reconstruction and Oncoplastic Cohort

NCT04030845 | Unknown DMC

• 1 other identifier: SCHBCC-N023
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

Available studies that focused on patient-reported outcomes (PROs) 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-reconstruction and oncoplastic cohort (PRO-ROC) will be planned to assess the PROs for Chinese breast cancer patients who will undergo breast reconstruction or oncoplastic breast-conserving surgery (OBCS). The inclusion criteria are female breast cancer patients \>18 years old, who will undergo breast reconstruction (BR) or OBCS. This cohort will include at least 10000 patients (about 5000 patients who undergo BR, and 5000 patients who undergo OBCS). The exposures were the surgery types: BR and OBCS regardless of the techniques and materials they used. The primary endpoint will be PROs, which include BREAST-Q, quality of life (EORTC QLQ-C30), EORTC QLQ-BR23). This study follows the Helsinki Declaration and Chinese rules. All patients will be asked to to sign the informed consent and will be followed up 24 months after operations. All data will be collected using an app software.

Conditions

Patient Reported Outcome Measures; Breast Reconstruction; Oncoplastic Breast-conserving Surgery; Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Change from baseline in 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 1 year and 2 years post-operatively.

• Change from baseline in health-related quality of life measured by EORTC QLQ-C30

  To compare change in Quality of Life, as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30 (Version 3)) from baseline at 1 year and 2 years post-operatively. 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.

• Change from baseline in health-related quality of life measured by 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.

Secondary Outcomes (5)

• Rates of complications

  up to 24 months

• Change from baseline in cosmetic scores rated by patients

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

• breast aesthetics

  up to 24 months

• Overall survival

  up to 24 months

• Recurrence-free survival

  up to 24 months

Other Outcomes (1)

• change from baseline in Visual Analog Score for pain

  Change from baseline at 1 day, 3 days, 7 days, 3 months, 1 year and 2 years post-operatively.

Study Arms (2)

breast reconstruction

Procedure: breast reconstruction

oncoplastic breast-conserving surgery

Procedure: oncoplastic breast-conserving surgery

Interventions

breast reconstruction PROCEDURE

The breast reconstruction mainly included autologous tissue flaps (latissimus dorsi myocutaneous flaps, pedicled tansverse rectus abdominis myocutaneous flaps, free transverse rectus abdominis musculocutaneous flaps, deep inferior epigastric artery perforator flaps, etc.), implant based breast reconstruction, autologous flaps combined with implant reconstruction, fat graft, etc.

breast reconstruction

oncoplastic breast-conserving surgery PROCEDURE

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

oncoplastic breast-conserving surgery

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients are confirmed by histopathologic evaluation without distant metastasis (M0). 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:

• Breast cancer patients;
• Adult (\>18 years old);
• Female;
• Must undergo breast reconstruction or oncoplastic breast-conserving surgery;

You may not qualify if:

• Younger (\<18 years old);
• Male;
• Stage IV breast cancer patients;
• Refuse to undergo breast reconstruction or oncoplastic breast-conserving surgery.

Sponsors & Collaborators

• Fudan University: lead
• First Affiliated Hospital of Chongqing Medical University: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• First Hospital of China Medical University: collaborator
• Guangdong Provincial People's Hospital: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• The First Affiliated Hospital of Air Force Medicial University: collaborator
• Hunan Province Cancer Hospital and the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University: collaborator
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator
• First Affiliated Hospital of Zhejiang University: collaborator
• The First Affiliated Hospital of Xiamen University: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• Hubei Cancer Hospital: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• First People's Hospital of Hangzhou: collaborator

Study Sites (1)

Shanghai Cancer Center, Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Related Publications (2)

• Chi W, Zhang Q, Li L, Chen M, Xiu B, Yang B, Wu J. Immediate Breast Reconstruction After Neoadjuvant Chemotherapy: Factors Associated With Surgical Selection and Complications. Ann Plast Surg. 2023 Jul 1;91(1):48-54. doi: 10.1097/SAP.0000000000003574. Epub 2023 May 19.

  PMID: 37216212 DERIVED

• Li L, Yang B, Li H, Yin J, Jin F, Han S, Liao N, Shi J, Ling R, Li Z, Ouyang L, Wang X, Fu P, Ouyang Z, Ma B, Wu X, Wang H, Liu J, Shao Z, Wu J. Chinese multicentre prospective registry of breast cancer patient-reported outcome-reconstruction and oncoplastic cohort (PRO-ROC): a study protocol. BMJ Open. 2019 Dec 15;9(12):e032945. doi: 10.1136/bmjopen-2019-032945.

  PMID: 31843846 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammaplasty

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Breast Surgery Vice President Cancer Hospital/Institute, Fudan University

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 24, 2019
• Study Start: July 1, 2019
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: July 25, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)