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. 2021 Oct 29;2021(10):CD013658. doi: 10.1002/14651858.CD013658.pub2

NCT04030845.

Study name Patient reported outcome ‐ reconstruction and oncoplastic cohort (PRO‐ROC)
Methods Prospective cohort study
10000 patients
Participants Inclusion

  • Breast cancer patients

  • Adult (> 18 years old)

  • Female

  • Must undergo breast reconstruction or oncoplastic breast‐conserving surgery


Exclusion

  • Younger (< 18 years old)

  • Male

  • Stage IV breast cancer patients

  • Refuse to undergo breast reconstruction or oncoplastic breast‐conserving surgery
Interventions Intervention: oncoplastic breast‐conserving surgery. The oncoplastic breast‐conserving surgery were mainly those surgeries using volume displacement or volume replacement techniques.
Control: breast reconstruction ‐ mainly included autologous tissue flaps (latissimus dorsi myocutaneous flaps, pedicled transverse 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.
Outcomes Primary outcome measures

  • Change from baseline in BREAST‐Q score (time frame: change from baseline at 1 year and 2 years post‐operatively)

  • Change from baseline in health‐related quality of life measured by What does Eortc QLQ‐C30 mean?European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ‐C30) (time frame: 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 (time frame: change from baseline at 1 year and 2 years post‐operatively)


Secondary outcome measures

  • Rates of complications (time frame: up to 24 months)

  • Change from baseline in cosmetic scores rated by patients (time frame: change from baseline at 1 year and 2 years post‐operatively)

  • Breast aesthetics (time frame: up to 24 months)

  • Overall survival (time frame: up to 24 months)

  • Recurrence‐free survival (time frame: up to 24 months)


Other outcome measures

  • Change from baseline in Visual Analog Score for pain (time frame: change from baseline at 1 day, 3 days, 7 days, 3 months, 1 year and 2 years post‐operatively)
Starting date July 2019 (estimated finish date December 2024)
Contact information  
Notes Recruitment status: recruiting