Breast CancerValPlastNCT05233891
Validation of Scales in Reconstructive Breast Surgery
An observational study of Breast Cancer and Breast Hypertrophy, run by Vastra Gotaland Region at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Breast Cancer, Breast Hypertrophy
- What is being tested?
- Breast reconstruction and Breast reduction
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteSweden
- Study dates
- 21 Jun 2021to 21 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who will have or have had reconstructive breast surgery.
Who may be able to join
- Women who have had or will have reconstructive breast surgery in Sahlgrenska university hospital.
Who cannot join
- Do not understand Swedish.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska university hospital
Gothenburg, 413 45
Emma Hansson, PhD, +46 31 342 10 00, emma.hansson.2@gu.se
About this study
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.
- Conditions
- Breast Cancer, Breast Hypertrophy
- Being tested
- Breast reconstruction, Breast reduction
- Keywords
- plastic surgery, breast reconstruction, patient reported outcome, complication
- Medical subject headings
- Breast Neoplasms, Gigantomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast reconstructionProcedure or surgery
Breast reconstruction after breast cancer.
Breast reductionProcedure or surgery
Also called mammoplasty reduction
Breast reduction due to breast hypertrophy.
| Study group | Role | What they receive |
|---|---|---|
| Breast reconstruction after breast cancer | Women who have had/have breast cancer and will have/have had a breast reconstruction. Receives: Procedure: Breast reconstruction | |
| Breast reduction | Women who have had/will have a breast reduction due to breast hypertrophy. Receives: Procedure: Breast reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start21 Jun 2021
- Primary completion21 Dec 2027 (estimated)
- Study completion21 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233891
- Sponsor's protocol ID
- 2021-03165
- Acronym
- ValPlast
- Status last verified
- Jun 2025
- First submitted
- 23 Jan 2022
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34929423Kamya 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.
PubMed 34217326Weick 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.
PubMed 35533094Jepsen C, Paganini A, Hansson E. Validation and reliability testing of the Swedish version of the BREAST-Q reconstruction. Scand J Surg. 2026 Mar;115(1):88-96. doi: 10.1177/14574969251387498. Epub 2025 Oct 26.
PubMed 41139858
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Scales in Reconstructive Breast Surgery
- ClinicalTrials.gov ID
- NCT05233891
- Acronym / sponsor ID
- ValPlast / 2021-03165
- Conditions
- Breast Cancer, Breast Hypertrophy
- Keywords
- plastic surgery, breast reconstruction, patient reported outcome, complication
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 21 Dec 2027 (estimated)
- Study completion
- 21 Dec 2027 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast reconstruction after breast cancer | – | Procedure: Breast reconstructionWomen who have had/have breast cancer and will have/have had a breast reconstruction. |
| Breast reduction | – | Procedure: Breast reductionWomen who have had/will have a breast reduction due to breast hypertrophy. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who will have or have had reconstructive breast surgery.
Key inclusion criteria (1 listed)
- Women who have had or will have reconstructive breast surgery in Sahlgrenska university hospital.
Key exclusion criteria (1 listed)
- Do not understand Swedish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast reconstructionBreast reconstruction after breast cancer. | Procedure or surgery | Breast reconstruction after breast cancer |
| Breast reductionAlso: mammoplasty reductionBreast reduction due to breast hypertrophy. | Procedure or surgery | Breast reduction |
Primary outcome
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.
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.
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.
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.
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).
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).
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Results publication: PubMed 34929423Weick 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.
- Results publication: PubMed 34217326Kamya 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.
- Results publication: PubMed 35533094Weick 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.
- Derived from this study: PubMed 41139858Jepsen C, Paganini A, Hansson E. Validation and reliability testing of the Swedish version of the BREAST-Q reconstruction. Scand J Surg. 2026 Mar;115(1):88-96. doi: 10.1177/14574969251387498. Epub 2025 Oct 26.
- Full text articleLink provided by the sponsor.
- Full text articleLink provided by the sponsor.
- Full text articleLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
RecruitingPhase 1/2
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
Breast Cancer
Not yet recruiting
Podcast-Based Psychosocial Support for Women Newly Diagnosed With Breast Cancer
Breast Cancer
Recruiting
A Study of Skipping Radiation Therapy in People With Breast Cancer
HER2-positive Breast Cancer, Breast Cancer
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Breast Hypertrophy, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Hansson, MD, PhD (+46313421000, emma.em.hansson@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation and reliability of BREAST-Q for Sweden (time frame: Pre-operatively). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05233891, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.