Patient Report Outcome-Reconstruction and Oncoplastic Cohort (PRO-ROC)
Status
Conditions
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Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Breast cancer patients;
- Adult (>18 years old);
- Female;
- Must undergo breast reconstruction or oncoplastic breast-conserving surgery;
Exclusion criteria
- Younger (<18 years old);
- Male;
- Stage IV breast cancer patients;
- Refuse to undergo breast reconstruction or oncoplastic breast-conserving surgery.
Trial design
10,000 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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