Clinical trial NCT04030845: Patient Report Outcome-Reconstruction and Oncoplastic Cohort
Official title: Chinese Multicenter Prospective Registry of Breast Cancer Patient Reported Outcome -Reconstruction and Oncoplastic Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patient Reported Outcome Measures
Breast Reconstruction
Oncoplastic Breast-conserving Surgery
Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Chongqing Medical University
name: Tianjin Medical University Cancer Institute and Hospital
name: First Hospital of China Medical University
name: Guangdong Provincial People's Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: The First Affiliated Hospital of Air Force Medicial University
name: Hunan Province Cancer Hospital and the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: First Affiliated Hospital of Zhejiang University
name: The First Affiliated Hospital of Xiamen University
name: First Affiliated Hospital of Xinjiang Medical University
name: Hubei Cancer Hospital
name: The Affiliated Hospital of Qingdao University
name: First People's Hospital of Hangzhou
First posted: 2019-07-24
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

1. Breast cancer patients;
2. Adult (\>18 years old);
3. Female;
4. Must undergo breast reconstruction or oncoplastic breast-conserving surgery;

Exclusion Criteria:

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

Primary outcomes:
measure: Change from baseline in BREAST-Q score
timeFrame: Change from baseline at 1 year and 2 years post-operatively.
measure: Change from baseline in health-related quality of life measured by EORTC QLQ-C30
timeFrame: Change from baseline at 1 year and 2 years post-operatively.
measure: Change from baseline in health-related quality of life measured by EORTC QLQ-BR23
timeFrame: Change from baseline at 1 year and 2 years post-operatively.
Secondary outcomes:
measure: Rates of complications
timeFrame: up to 24 months
measure: Change from baseline in cosmetic scores rated by patients
timeFrame: Change from baseline at 1 year and 2 years post-operatively.
measure: breast aesthetics
timeFrame: up to 24 months
measure: Overall survival
timeFrame: up to 24 months
measure: Recurrence-free survival
timeFrame: up to 24 months
Other outcomes:
measure: change from baseline in Visual Analog Score for pain
timeFrame: Change from baseline at 1 day, 3 days, 7 days, 3 months, 1 year and 2 years post-operatively.
Locations:
city: Shanghai
country: China
facility: Shanghai Cancer Center, Fudan University
state: Shanghai
Study officials:
References:
citation: 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.