Validation of Scales in Reconstructive Breast Surgery

Breast Cancer Clinical Trial

— ValPlast  

Official title:

Validation of Scales in Reconstructive Breast Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05233891
• Other study ID #: 2021-03165
• Status: Recruiting
• Start date: June 21, 2021
• Est. completion date: December 21, 2027

Study information

• Verified date: December 2023
• Source: Vastra Gotaland Region
• Contact: Emma Hansson, MD, PhD
• Phone: +46313421000
• Email: emma.em.hansson[@]vgregion.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 21, 2027
• Est. primary completion date: December 21, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Do not understand Swedish.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Hypertrophy
• Hypertrophy

Intervention

Procedure:
• Breast reconstruction
Breast reconstruction after breast cancer.
• Breast reduction
Breast reduction due to breast hypertrophy.

Locations

Country	Name	City	State
Sweden	Sahlgrenska university hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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: — View 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. d — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation and reliability of BREAST-Q for Sweden	Breast-Q measures breast related quality of life on a scale 1-100. A higher score indicates a higher quality of life.	Pre-operatively
Primary	Validation and reliability of BREAST-Q for Sweden	Breast-Q measures breast related quality of life on a scale 1-100. A higher score indicates a higher quality of life.	5 years postoperatively
Primary	Validation and reliability of EuroQol-5 dimensions, 3 levels for reconstructive breast surgery	EuroQol-5 dimensions-3 levels (EQ5D) is a generic instrument developed for health economic and clinical evaluation of healthcare. A total score between 0 and 1 is calculated. Zero equals death and 1 perfect health.	Pre-operatively
Primary	Validation and reliability of EuroQol-5 dimensions, 3 levels for reconstructive breast surgery	EuroQol-5 dimensions-3 levels (EQ5D) is a generic instrument developed for health economic and clinical evaluation of healthcare. A total score between 0 and 1 is calculated. Zero equals death and 1 perfect health.	5 years postoperatively
Primary	Validation and reliability of Hospital Anxiety and Depression scale (HADS) for Reconstructive breast surgery	The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21).	Pre-operatively
Primary	Validation and reliability of Hospital Anxiety and Depression scale (HADS) for Reconstructive breast surgery	The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21).	5 years postoperatively
Primary	Validation and reliability of RAND-36 for reconstructive breast surgery	It comprises eight subdomains: physical functioning (10 items), role limitations caused by physical health problems (4 items), role limitations caused by emotional problems (3 items), social functioning (2 items), emotional well-being (5 items), energy/fatigue (4 items), pain (2 items), and general health perceptions (5 items) where patients score their health during the last four weeks on Likert scales. Every item score is transformed linearly to the per cent of total possible score (0-100) and then averaged by the values of the scale. A subscore is calculated for each domain and in addition two summary scores, physical and mental health, are calculated.	Pre-operatively
Primary	Validation and reliability of RAND-36 for reconstructive breast surgery	It comprises eight subdomains: physical functioning (10 items), role limitations caused by physical health problems (4 items), role limitations caused by emotional problems (3 items), social functioning (2 items), emotional well-being (5 items), energy/fatigue (4 items), pain (2 items), and general health perceptions (5 items) where patients score their health during the last four weeks on Likert scales. Every item score is transformed linearly to the per cent of total possible score (0-100) and then averaged by the values of the scale. A subscore is calculated for each domain and in addition two summary scores, physical and mental health, are calculated.	5 years postoperatively
Primary	Validation of Clavion-Dindo classification for reconstructive breast surgery	The Clavien-Dindo system is based on ranking the severity of the intervention required to treat a given complication, as follows: grade I includes deviations from the postoperative course without the need for pharmacological treatment or surgical/endoscopic/radiological intervention; grade II complications require pharmacological treatment, blood transfusion, or total parental nutrition; grade III complications require surgical/endoscopic/radiological intervention; grade IV includes life-threatening complications, including those involving the central nervous system, that require intensive care treatment; and grade V includes complications that result in death.	5 years postoperatively

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