Validation of Scales in Reconstructive Breast Surgery

NCT ID: NCT05233891

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-21

Study Completion Date

2027-12-21

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Breast Hypertrophy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast reconstruction after breast cancer

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

Breast reconstruction

Intervention Type PROCEDURE

Breast reconstruction after breast cancer.

Breast reduction

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

Breast reduction

Intervention Type PROCEDURE

Breast reduction due to breast hypertrophy.

Interventions

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Breast reconstruction

Breast reconstruction after breast cancer.

Intervention Type PROCEDURE

Breast reduction

Breast reduction due to breast hypertrophy.

Intervention Type PROCEDURE

Other Intervention Names

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mammoplasty reduction

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Do not understand Swedish.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sahlgrenska university hospital

Gothenburg, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Emma Hansson, MD, PhD

Role: CONTACT

+46313421000

Facility Contacts

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Emma Hansson, PhD

Role: primary

+46 31 342 10 00

References

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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.

Reference Type RESULT
PMID: 34929423 (View on PubMed)

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.

Reference Type RESULT
PMID: 34217326 (View on PubMed)

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.

Reference Type RESULT
PMID: 35533094 (View on PubMed)

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.

Reference Type DERIVED
PMID: 41139858 (View on PubMed)

Related Links

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Other Identifiers

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2021-03165

Identifier Type: -

Identifier Source: org_study_id

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