Validating patient-reported outcomes in breast reconstruction
Validation of Scales in Reconstructive Breast Surgery
Vastra Gotaland Region · NCT05233891
This study is testing if certain questionnaires can accurately capture how patients feel after breast reconstruction surgery to help improve their care and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | Vastra Gotaland Region (other gov) |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT05233891 on ClinicalTrials.gov |
What this trial studies
This project aims to validate patient-reported outcome measures (PROMs) specifically for reconstructive breast surgery. It will assess the BREAST-Q tool along with the Hospital Anxiety and Depression Scale (HADS), EuroQol 5D (EQ5D), and SF-36 to ensure their effectiveness in this context. Additionally, the study will validate the Clavien-Dindo complication classification system for use in reconstructive breast surgery. The focus is on gathering reliable data to improve patient care and outcomes in breast reconstruction.
Who should consider this trial
Good fit: Ideal candidates are women who have had or will have reconstructive breast surgery at Sahlgrenska University Hospital.
Not a fit: Patients who do not understand Swedish will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of care and outcomes for patients undergoing reconstructive breast surgery.
How similar studies have performed: Other studies have shown success in validating patient-reported outcomes in surgical contexts, making this approach promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women who have had or will have reconstructive breast surgery in Sahlgrenska university hospital. Exclusion Criteria: * Do not understand Swedish.
Where this trial is running
Gothenburg
- Sahlgrenska university hospital — Gothenburg, Sweden (RECRUITING)
Study contacts
- Study coordinator: Emma Hansson, MD, PhD
- Email: emma.em.hansson@vgregion.se
- Phone: +46313421000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Breast Hypertrophy, plastic surgery, breast reconstruction, patient reported outcome, complication