NCT05233891

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Jun 2021Dec 2027

Study Start

First participant enrolled

June 21, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2027

Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

6.5 years

First QC Date

January 23, 2022

Last Update Submit

June 30, 2025

Conditions

Breast CancerBreast Hypertrophy

Keywords

plastic surgerybreast reconstructionpatient reported outcomecomplication

Outcome Measures

Primary Outcomes (9)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Breast reconstruction after breast cancer

Women who have had/have breast cancer and will have/have had a breast reconstruction.

Procedure: Breast reconstruction

Breast reduction

Women who have had/will have a breast reduction due to breast hypertrophy.

Procedure: Breast reduction

Interventions

Breast reconstructionPROCEDURE

Breast reconstruction after breast cancer.

Breast reconstruction after breast cancer
Breast reductionPROCEDURE

Breast reduction due to breast hypertrophy.

Also known as: mammoplasty reduction
Breast reduction

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen who are biological women and identify as cis-women.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women who will have or have had reconstructive breast surgery.

You may qualify if:

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

You may not qualify if:

  • Do not understand Swedish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska university hospital

Gothenburg, 413 45, Sweden

RECRUITING

Related Publications (4)

  • 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: 34929423RESULT

  • 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: 34217326RESULT

  • 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: 35533094RESULT

  • Jepsen C, Paganini A, Hansson E. Validation and reliability testing of the Swedish version of the BREAST-Q reconstruction. Scand J Surg. 2025 Oct 26:14574969251387498. doi: 10.1177/14574969251387498. Online ahead of print.

    PMID: 41139858DERIVED

Related Links

MeSH Terms

Conditions

Breast NeoplasmsGigantomastia

Interventions

Mammaplasty

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsPlastic Surgery ProceduresSurgical Procedures, Operative

Central Study Contacts

Emma Hansson, MD, PhD

CONTACT

+46313421000emma.em.hansson@vgregion.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2022

First Posted

February 10, 2022

Study Start

June 21, 2021

Primary Completion (Estimated)

December 21, 2027

Study Completion (Estimated)

December 21, 2027

Last Updated

July 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)