Validation of Scales in Reconstructive Breast Surgery
The main purpose of the project is to validate patient reported outcomes measures (PROMs) in reconstructive breast surgery. BREAST-Q will be evaluated for Swedish and Sweden.Hospital Anxiety and Depression Scale (HADS), EuroQol 5D (EQ5D), and SF-36 will be validated for reconstructive breast surgery. In addition, the complication classification system according to Clavien-Dindo will be validated for reconstructive breast surgery.
Conditions studied
Breast Cancer, Breast Hypertrophy
About this study
The main purpose of the project is to validate patient reported outcomes measures (PROMs) in reconstructive breast surgery. BREAST-Q will be evaluated for Swedish and Sweden.Hospital Anxiety and Depression Scale (HADS), EuroQol 5D (EQ5D), and SF-36 will be validated for reconstructive breast surgery. In addition, the complication classification system according to Clavien-Dindo will be validated for reconstructive breast surgery.
Interventions
- Procedure: Breast reconstruction — Breast reconstruction after breast cancer.
- Procedure: Breast reduction — Breast reduction due to breast hypertrophy.
Primary outcomes
- Validation and reliability of BREAST-Q for Sweden (Pre-operatively)
- Validation and reliability of BREAST-Q for Sweden (5 years postoperatively)
- Validation and reliability of EuroQol-5 dimensions, 3 levels for reconstructive breast surgery (Pre-operatively)
- Validation and reliability of EuroQol-5 dimensions, 3 levels for reconstructive breast surgery (5 years postoperatively)
- Validation and reliability of Hospital Anxiety and Depression scale (HADS) for Reconstructive breast surgery (Pre-operatively)
- Validation and reliability of Hospital Anxiety and Depression scale (HADS) for Reconstructive breast surgery (5 years postoperatively)
- Validation and reliability of RAND-36 for reconstructive breast surgery (Pre-operatively)
- Validation and reliability of RAND-36 for reconstructive breast surgery (5 years postoperatively)
Eligibility information
Study locations
- Sahlgrenska university hospital, Gothenburg, 413 45 Sweden
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.