Breast CancerNCT04714463
Effects of Expectations and Body Image in Breast Reconstruction
An observational study of Breast Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
A breast reconstruction after mastectomy, either due to breast cancer or a high lifetime risk for cancer, is performed to increase the patient's quality of life. However, there are studies that show that some women regret their decision to have breast reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Implant-based breast reconstruction, Autologous breast reconstruction and Combined methods
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2021to 31 Dec 2026
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Biological women with breast cancer or high risk for breast cancer who want immediate or delayed post-mastectomy breast reconstruction.
Who may be able to join
- Biological women with breast cancer or high risk for breast cancer who want post-mastectomy breast reconstruction
- Age > 18 years
Who cannot join
- Inability to give informed consent
- Inability to understand Swedish
- Relaps of cancer
- Palliative treatment
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
Linn Weick, MA, +46 31 342 10 00, linn.weick@vgregion.se
About this study
Official title: Psychological Effect of Expectations and Body Image on Outcomes of Breast Reconstruction
A breast reconstruction after mastectomy, either due to breast cancer or a high lifetime risk for cancer, is performed to increase the patient's quality of life. However, there are studies that show that some women regret their decision to have breast reconstruction. There are also studies demonstrating similarities in the general patterns of psychosocial adjustment and quality of life among women with breast cancer who have undergone breast-conserving surgery, mastectomy alone, and mastectomy combined with breast reconstruction. Hence, it is unclear which women actually benefit from a breast reconstruction. The concept of quality of life is connected to patient satisfaction and body image/investment. Therefore, the aim of this project is to examine the effects of patient expectations and body image on the patient reported outcomes of breast reconstruction, to improve preoperative information and postoperative care for women considering a breast reconstruction.
- Conditions
- Breast Cancer
- Being tested
- Implant-based breast reconstruction, Autologous breast reconstruction, Combined methods
- Keywords
- plastic surgery, breast reconstruction, complication, expectations, body image
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant-based breast reconstructionProcedure or surgery
All types of implant based breast reconstructions
Autologous breast reconstructionProcedure or surgery
All types of autologous breast reconstructions
Combined methodsProcedure or surgery
All types of breast reconstructions combining autologous and implant based techniques
| Study group | Role | What they receive |
|---|---|---|
| Immediate breast reconstruction | Women undergoing immediate breast reconstruction due to breast cancer or a high risk for breast cancer Receives: Procedure: Implant-based breast reconstruction; Procedure: Autologous breast reconstruction; Procedure: Combined methods | |
| Delayed breast reconstruction | Women undergoing delayed breast reconstruction due to breast cancer or a high risk for breast cancer Receives: Procedure: Implant-based breast reconstruction; Procedure: Autologous breast reconstruction; Procedure: Combined methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction with breast reconstruction measured with Breast Q reconstruction
Breast Q reconstruction includes two domains and six different modules: health-related quality of life (HR-QOL; including physical, psychosocial, and sexual well-being) and patient satisfaction (including satisfaction with breasts, outcome, and care). Each scale produces an independent score from 0-100. A higher score means greater satisfaction or better QOL.
Measured: 2 years
Patient expectations measured with Breast Q expectations
Breast Q expectations.The scale consists of five modules: expectations for support from medical staff , expectations for pain, expectations for coping, expectations for breast appearance when clothed and expectations for breast sensation. The score for each independent scale range from 0-100. A higher score means greater expectations.
Measured: 2 years
Body image measured with Multidimensional body-self relations questionnaire- appearance scales (MBSRQ-AS)
MBSRQ-AS - Multidimensional body-self relations questionnaire- appearance scales.It is a 34-item self-report questionnaire designed to measure appearance related components of body-image. In consists of five subscales: appearance evaluation, appearance orientation, body areas satisfaction, overweight preoccupation, and self-classified weight. It is a 5-point Likert-scale ranging from 1 to 5.
Measured: 2 years
Body image investment measured with Appearance schemas inventory-revised (ASI-R)
ASI-R - Appearance schemas inventory-revised: is a 20-item self-report questionnaire designed to measure body-image investment. It consists of two subscales, self-evaluative salience (SES) and motivational salience (MS). It is a 5-point Likert-scale ranging from 1 (strongly disagree) to 5 (strongly agree). Twelve items relate to SES and eight items relate to MS. The total score is the mean of the 20 items, and the score of the subscales is the mean of the items relating to each subscale. A high score indicates greater body-image investment.
Measured: 2 years
Secondary outcomes (6)
Satisfaction with preoperative information measured with Breast Q reconstruction
Measured with one of the sub scales of Breast Q reconstruction
Measured: 2 years
Pain measured with a visual analogue scale
Measured with a post-operative pain dairy with VAS scales (o means no pain and 10 means the worst possible pain imaginable)
Measured: 2 weeks
Sick leave according to authorities
Actual sick leave according to the Swedish authorities
Measured: 1 year
Number of out-patient visits according to the medical charts
Actual number of out-patient visits, according to the medical chart
Measured: 1 year
Depression and anxiety measured with Hospital Anxiety and Depression Scale (HADS)
HADS - Hospital Anxiety and Depression Scale: is a 14-item self-report questionnaire that is designed to measure anxiety and depression. It has two domains, where seven items relate to anxiety and seven relate to depression. It is a 4-point Likert-scale ranging from 0-3. Each domain has a maximum score of 21. For both domains, scores of less than 7 indicate non-cases, whereas scores of 8-10 indicate mild anxiety or depression, 11-14 moderate and 15-21 severe.
Measured: 2 years
Demographic factors and medical factors according to medical charts
Demographic factors that might affect expectations and satisfaction, such as age, comorbidity, and previous cosmetic breast surgery, and medical factors such as timing of reconstructions, reason for mastectomy, type of cancer and cancer treatment received.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start1 Feb 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- Investigators
- Emma Hansson, PhD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714463
- Sponsor's protocol ID
- 2020-06245
- Status last verified
- Jun 2025
- First submitted
- 12 Jan 2021
- 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
Jepsen 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 41139858Weick 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 35533094
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
- Psychological Effect of Expectations and Body Image on Outcomes of Breast Reconstruction
- ClinicalTrials.gov ID
- NCT04714463
- Acronym / sponsor ID
- 2020-06245
- Conditions
- Breast Cancer
- Keywords
- plastic surgery, breast reconstruction, complication, expectations, body image
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Jan 2021 (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.
A breast reconstruction after mastectomy, either due to breast cancer or a high lifetime risk for cancer, is performed to increase the patient's quality of life. However, there are studies that show that some women regret their decision to have breast reconstruction. There are also studies demonstrating similarities in the general patterns of psychosocial adjustment and quality of life among women with breast cancer who have undergone breast-conserving surgery, mastectomy alone, and mastectomy combined with breast reconstruction. Hence, it is unclear which women actually benefit from a breast reconstruction. The concept of quality of life is connected to patient satisfaction and body image/investment. Therefore, the aim of this project is to examine the effects of patient expectations and body image on the patient reported outcomes of breast reconstruction, to improve preoperative information and postoperative care for women considering a breast reconstruction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate breast reconstruction | – | Procedure: Implant-based breast reconstruction, Procedure: Autologous breast reconstruction, Procedure: Combined methodsWomen undergoing immediate breast reconstruction due to breast cancer or a high risk for breast cancer |
| Delayed breast reconstruction | – | Procedure: Implant-based breast reconstruction, Procedure: Autologous breast reconstruction, Procedure: Combined methodsWomen undergoing delayed breast reconstruction due to breast cancer or a high risk for breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Biological women with breast cancer or high risk for breast cancer who want immediate or delayed post-mastectomy breast reconstruction.
Key inclusion criteria (2 listed)
- Biological women with breast cancer or high risk for breast cancer who want post-mastectomy breast reconstruction
- Age > 18 years
Key exclusion criteria (4 listed)
- Inability to give informed consent
- Inability to understand Swedish
- Relaps of cancer
- Palliative treatment
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 |
|---|---|---|
| Implant-based breast reconstructionAll types of implant based breast reconstructions | Procedure or surgery | Delayed breast reconstruction, Immediate breast reconstruction |
| Autologous breast reconstructionAll types of autologous breast reconstructions | Procedure or surgery | Delayed breast reconstruction, Immediate breast reconstruction |
| Combined methodsAll types of breast reconstructions combining autologous and implant based techniques | Procedure or surgery | Delayed breast reconstruction, Immediate breast reconstruction |
Primary outcome
Patient satisfaction with breast reconstruction measured with Breast Q reconstruction
Time frame: 2 years
Breast Q reconstruction includes two domains and six different modules: health-related quality of life (HR-QOL; including physical, psychosocial, and sexual well-being) and patient satisfaction (including satisfaction with breasts, outcome, and care). Each scale produces an independent score from 0-100. A higher score means greater satisfaction or better QOL.
Patient expectations measured with Breast Q expectations
Time frame: 2 years
Breast Q expectations.The scale consists of five modules: expectations for support from medical staff , expectations for pain, expectations for coping, expectations for breast appearance when clothed and expectations for breast sensation. The score for each independent scale range from 0-100. A higher score means greater expectations.
Body image measured with Multidimensional body-self relations questionnaire- appearance scales (MBSRQ-AS)
Time frame: 2 years
MBSRQ-AS - Multidimensional body-self relations questionnaire- appearance scales.It is a 34-item self-report questionnaire designed to measure appearance related components of body-image. In consists of five subscales: appearance evaluation, appearance orientation, body areas satisfaction, overweight preoccupation, and self-classified weight. It is a 5-point Likert-scale ranging from 1 to 5.
Body image investment measured with Appearance schemas inventory-revised (ASI-R)
Time frame: 2 years
ASI-R - Appearance schemas inventory-revised: is a 20-item self-report questionnaire designed to measure body-image investment. It consists of two subscales, self-evaluative salience (SES) and motivational salience (MS). It is a 5-point Likert-scale ranging from 1 (strongly disagree) to 5 (strongly agree). Twelve items relate to SES and eight items relate to MS. The total score is the mean of the 20 items, and the score of the subscales is the mean of the items relating to each subscale. A high score indicates greater body-image investment.
6 secondary outcomes
Satisfaction with preoperative information measured with Breast Q reconstruction
Time frame: 2 years
Pain measured with a visual analogue scale
Time frame: 2 weeks
Sick leave according to authorities
Time frame: 1 year
Number of out-patient visits according to the medical charts
Time frame: 1 year
Depression and anxiety measured with Hospital Anxiety and Depression Scale (HADS)
Time frame: 2 years
Demographic factors and medical factors according to medical charts
Time frame: 2 years
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.
- 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.
- Derived from this study: 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.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Emma Hansson, PhD principal investigator
Göteborg University
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, 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 2 inclusion and 4 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, 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?
Patient satisfaction with breast reconstruction measured with Breast Q reconstruction (time frame: 2 years). The study lists 4 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 NCT04714463, which also lists 2 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.