Clinical trial NCT05233891: Validation of Scales in Reconstructive Breast Surgery
Official title: Validation of Scales in Reconstructive Breast Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Breast Hypertrophy
Keywords: plastic surgery
breast reconstruction
patient reported outcome
complication
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2022-02-10
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who will have or have had reconstructive breast surgery.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Do not understand Swedish.

Primary outcomes:
measure: Validation and reliability of BREAST-Q for Sweden
timeFrame: Pre-operatively
measure: Validation and reliability of BREAST-Q for Sweden
timeFrame: 5 years postoperatively
measure: Validation and reliability of EuroQol-5 dimensions, 3 levels for reconstructive breast surgery
timeFrame: Pre-operatively
measure: Validation and reliability of EuroQol-5 dimensions, 3 levels for reconstructive breast surgery
timeFrame: 5 years postoperatively
measure: Validation and reliability of Hospital Anxiety and Depression scale (HADS) for Reconstructive breast surgery
timeFrame: Pre-operatively
measure: Validation and reliability of Hospital Anxiety and Depression scale (HADS) for Reconstructive breast surgery
timeFrame: 5 years postoperatively
measure: Validation and reliability of RAND-36 for reconstructive breast surgery
timeFrame: Pre-operatively
measure: Validation and reliability of RAND-36 for reconstructive breast surgery
timeFrame: 5 years postoperatively
measure: Validation of Clavion-Dindo classification for reconstructive breast surgery
timeFrame: 5 years postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska university hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.