Patient Report Outcome-Reconstruction and Oncoplastic Cohort

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2024-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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breast reconstruction

Intervention Type 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.

oncoplastic breast-conserving surgery

Intervention Type PROCEDURE

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

Interventions

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breast reconstruction

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.

Intervention Type PROCEDURE

oncoplastic breast-conserving surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No