Clinical trial · Observational
Validation of Scales in Reconstructive Breast Surgery
NCT05233891CI-TRIAL-00091697ValPlastrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Hypertrophy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast reconstruction | Procedure | — | UNRESOLVED |
| Breast reduction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Breast reconstruction after breast cancer
- description
- Women who have had/have breast cancer and will have/have had a breast reconstruction.
- interventionNames
- Procedure: Breast reconstruction
- label
- Breast reduction
- description
- Women who have had/will have a breast reduction due to breast hypertrophy.
- interventionNames
- Procedure: Breast reduction
Primary outcomes (9)
- measure
- Validation and reliability of BREAST-Q for Sweden
- timeFrame
- Pre-operatively
- description
- Breast-Q measures breast related quality of life on a scale 1-100. A higher score indicates a higher quality of life.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Women who have had or will have reconstructive breast surgery in Sahlgrenska university hospital. Exclusion Criteria: * Do not understand Swedish.
References
Publications (4)
- RESULTWeick L, Brorson F, Jepsen C, Liden M, Jensen EW, Hansson E. Giving meaning to patient reported outcomes in breast reconstruction after mastectomy - A systematic review of available scores and suggestions for further research. Breast. 2022 Feb;61:91-97. doi: 10.1016/j.breast.2021.11.008. Epub 2021 Nov 25. PMID 34929423
- RESULTKamya L, Hansson E, Weick L, Hansson E. Validation and reliability testing of the Breast-Q latissimus dorsi questionnaire: cross-cultural adaptation and psychometric properties in a Swedish population. Health Qual Life Outcomes. 2021 Jul 3;19(1):174. doi: 10.1186/s12955-021-01812-x. PMID 34217326
- RESULTWeick L, Grimby-Ekman A, Lunde C, Hansson E. Validation and reliability testing of the BREAST-Q expectations questionnaire in Swedish. J Plast Surg Hand Surg. 2023 Feb-Dec;57(1-6):315-323. doi: 10.1080/2000656X.2022.2070180. Epub 2022 May 9. PMID 35533094
- DERIVEDJepsen C, Paganini A, Hansson E. Validation and reliability testing of the Swedish version of the BREAST-Q reconstruction. Scand J Surg. 2026 Mar;115(1):88-96. doi: 10.1177/14574969251387498. Epub 2025 Oct 26. PMID 41139858