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Recruiting NCT05233891

Validation of Scales in Reconstructive Breast Surgery

— Observational Breast Cancer Breast Hypertrophy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Breast reconstruction, Breast reduction.
Who it may be relevant to
Registry conditions: Breast Cancer, Breast Hypertrophy. Basic parameters: 18 years — 100 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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 outcome measures

  • Validation and reliability of BREAST-Q for Sweden [Time frame: Pre-operatively]
  • Validation and reliability of BREAST-Q for Sweden [Time frame: 5 years postoperatively]
  • Validation and reliability of EuroQol-5 dimensions, 3 levels for reconstructive breast surgery [Time frame: Pre-operatively]
  • Validation and reliability of EuroQol-5 dimensions, 3 levels for reconstructive breast surgery [Time frame: 5 years postoperatively]
  • Validation and reliability of Hospital Anxiety and Depression scale (HADS) for Reconstructive breast surgery [Time frame: Pre-operatively]
  • Validation and reliability of Hospital Anxiety and Depression scale (HADS) for Reconstructive breast surgery [Time frame: 5 years postoperatively]
  • Validation and reliability of RAND-36 for reconstructive breast surgery [Time frame: Pre-operatively]
  • Validation and reliability of RAND-36 for reconstructive breast surgery [Time frame: 5 years postoperatively]
  • Validation of Clavion-Dindo classification for reconstructive breast surgery [Time frame: 5 years postoperatively]

Eligibility criteria

Inclusion criteria

  • Women who have had or will have reconstructive breast surgery in Sahlgrenska university hospital.

Exclusion criteria

  • Do not understand Swedish.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Sahlgrenska university hospital — Gothenburg

Publications

  • Weick 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
  • Kamya 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
  • Weick 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
  • Jepsen 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

Identifiers

NCT: NCT05233891 · 2021-03165

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗