Validation of Scales in Reconstructive Breast Surgery (ValPlast)

June 30, 2025 updated by: Vastra Gotaland Region
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 413 45
        • Recruiting
        • Sahlgrenska University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women who will have or have had reconstructive breast surgery.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Do not understand Swedish.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Breast reconstruction after breast cancer
Women who have had/have breast cancer and will have/have had a breast reconstruction.
Procedure: Breast reconstruction
Breast reconstruction after breast cancer.
Breast reduction
Women who have had/will have a breast reduction due to breast hypertrophy.
Procedure: Breast reduction
Breast reduction due to breast hypertrophy.
Other Names:
  • mammoplasty reduction

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Validation and reliability of BREAST-Q for Sweden
Time Frame: Pre-operatively
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
Time Frame: 5 years postoperatively
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
Time Frame: Pre-operatively
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
Time Frame: 5 years postoperatively
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
Time Frame: Pre-operatively
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
Time Frame: 5 years postoperatively
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
Time Frame: Pre-operatively
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
Time Frame: 5 years postoperatively
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
Time Frame: 5 years postoperatively
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vastra Gotaland Region

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 21, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 21, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-03165

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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