Breast Cancer FemaleNCT04503018
Psychological Effects of Implant Loss
An observational study of Breast Cancer Female, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
Previous quality of life studies have suggested that long term satisfaction with breast reconstruction may be affected by postoperative complications. Complication frequencies, especially the risk for implant loss, is considerably higher in immediate than in delayed 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 Female
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2020to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Purposive criterion sampling technique is used. The population will identified through an operation planning software
Who may be able to join
- Biological women
- Age >18 years
- Have lost an implant after a mastectomy and immediate breast reconstruction
Who cannot join
- Inability to give informed consent
- inability to speak and understand Swedish
- relapse of breast cancer after the reconstruction
- metastatic disease
- psychiatric co-morbidity.
Trial locations and contacts
1 site in 1 country.
About this study
Previous quality of life studies have suggested that long term satisfaction with breast reconstruction may be affected by postoperative complications. Complication frequencies, especially the risk for implant loss, is considerably higher in immediate than in delayed breast reconstruction. Knowledge about how implant loss affects the patient's experience of her breast reconstruction can guide us in the choice between immediate and delayed breast reconstruction in high risk patients and help us better prepare the patients for possible complications. This study will investigate patients' experiences with losing an implant in connection with immediate breast reconstruction.
- Conditions
- Breast Cancer Female
- Keywords
- Breast reconstruction, Plastic surgery, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Interviewed -implant loss | Patients who have had immediate breast reconstruction and lost the implant due to for example infection. | |
| Questionnaires - implant loss | Patients who have had immediate breast reconstruction and lost the implant due to for example infection. | |
| Questionnaires - controls | Patients who have had immediate breast reconstruction without complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experiences and psychological effects of implant loss after immediate breast reconstruction
Interviews
Measured: 10 years
Effect on quality of life of implant loss: scale
Breast-Q reconstruction post-operative. It includes different domains: 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: 10 years
Effect on body image of implant loss
Body-Esteem Scale for Adolescents and Adults (BESAA). It consists of three subscales: BE-appearance, BE-weight and BE-attribution.The scale has 23 items and the respondents indicated their degree of agreement on a 5-point Likert scale ranging from 0 (never) to 4 (always).High score indicates higher dimensions of the Body Esteem.
Measured: 10 years
Effect on depression and anxiety of implant loss
Hospital Anxiety and Depression scale (HAD).The HADS is a fourteen item scale that generates: Seven of the items relate to anxiety and seven relate to depression.For both scales, scores of less than 7 indicate non-cases. 8-10 mild, 11-14 moderate, 15-21 severe.
Measured: 10 years
Coping strategies
Brief-cope, a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event.Scores are presented for the two overarching coping styles: avoidant and approach.The scale can determine someone's primary coping styles.
Measured: 10 years
Coping strategies
The Life orientation test - revised (Lot-R) is a 10-item scale that measures how optimistic or pessimistic people feel about the future. High values imply optimism.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start1 Mar 2020
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
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 Cancer FemaleStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
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
- NCT04503018
- Sponsor's protocol ID
- 2019-06214
- Other IDs
- 2019
- Status last verified
- Jun 2025
- First submitted
- 30 Jul 2020
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Weick L, Ericson A, Sandman L, Bostrom P, Hansson E. Patient experience of implant loss after immediate breast reconstruction: An interpretative phenomenological analysis. Health Care Women Int. 2023 Jan;44(1):61-79. doi: 10.1080/07399332.2021.1944152. Epub 2021 Aug 24.
PubMed 34427538Weick L, Lunde C, Hansson E. The effect of implant loss after immediate breast reconstruction on patient satisfaction with outcome and quality of life after five years - a case-control study. J Plast Surg Hand Surg. 2023 Feb-Dec;57(1-6):263-270. doi: 10.1080/2000656X.2022.2061501. Epub 2022 Apr 15.
PubMed 35427208
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 Effects of Implant Loss
- ClinicalTrials.gov ID
- NCT04503018
- Acronym / sponsor ID
- 2019-06214
- Conditions
- Breast Cancer Female
- Keywords
- Breast reconstruction, Plastic surgery, Psychology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 6 Aug 2020 (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.
Previous quality of life studies have suggested that long term satisfaction with breast reconstruction may be affected by postoperative complications. Complication frequencies, especially the risk for implant loss, is considerably higher in immediate than in delayed breast reconstruction. Knowledge about how implant loss affects the patient's experience of her breast reconstruction can guide us in the choice between immediate and delayed breast reconstruction in high risk patients and help us better prepare the patients for possible complications. This study will investigate patients' experiences with losing an implant in connection with immediate breast reconstruction.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interviewed -implant loss | – | –Patients who have had immediate breast reconstruction and lost the implant due to for example infection. |
| Questionnaires - implant loss | – | –Patients who have had immediate breast reconstruction and lost the implant due to for example infection. |
| Questionnaires - controls | – | –Patients who have had immediate breast reconstruction without complications |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Purposive criterion sampling technique is used. The population will identified through an operation planning software
Key inclusion criteria (3 listed)
- Biological women
- Age >18 years
- Have lost an implant after a mastectomy and immediate breast reconstruction
Key exclusion criteria (5 listed)
- Inability to give informed consent
- inability to speak and understand Swedish
- relapse of breast cancer after the reconstruction
- metastatic disease
- psychiatric co-morbidity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Experiences and psychological effects of implant loss after immediate breast reconstruction
Time frame: 10 years
Interviews
Effect on quality of life of implant loss: scale
Time frame: 10 years
Breast-Q reconstruction post-operative. It includes different domains: 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
Effect on body image of implant loss
Time frame: 10 years
Body-Esteem Scale for Adolescents and Adults (BESAA). It consists of three subscales: BE-appearance, BE-weight and BE-attribution.The scale has 23 items and the respondents indicated their degree of agreement on a 5-point Likert scale ranging from 0 (never) to 4 (always).High score indicates higher dimensions of the Body Esteem.
Effect on depression and anxiety of implant loss
Time frame: 10 years
Hospital Anxiety and Depression scale (HAD).The HADS is a fourteen item scale that generates: Seven of the items relate to anxiety and seven relate to depression.For both scales, scores of less than 7 indicate non-cases. 8-10 mild, 11-14 moderate, 15-21 severe.
Coping strategies
Time frame: 10 years
Brief-cope, a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event.Scores are presented for the two overarching coping styles: avoidant and approach.The scale can determine someone's primary coping styles.
Coping strategies
Time frame: 10 years
The Life orientation test - revised (Lot-R) is a 10-item scale that measures how optimistic or pessimistic people feel about the future. High values imply optimism.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Results publication: PubMed 34427538Weick L, Ericson A, Sandman L, Bostrom P, Hansson E. Patient experience of implant loss after immediate breast reconstruction: An interpretative phenomenological analysis. Health Care Women Int. 2023 Jan;44(1):61-79. doi: 10.1080/07399332.2021.1944152. Epub 2021 Aug 24.
- Results publication: PubMed 35427208Weick L, Lunde C, Hansson E. The effect of implant loss after immediate breast reconstruction on patient satisfaction with outcome and quality of life after five years - a case-control study. J Plast Surg Hand Surg. 2023 Feb-Dec;57(1-6):263-270. doi: 10.1080/2000656X.2022.2061501. Epub 2022 Apr 15.
- Full text articleLink provided by the sponsor.
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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. This study is not recruiting at the moment.
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 Female, 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 3 inclusion and 5 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experiences and psychological effects of implant loss after immediate breast reconstruction (time frame: 10 years). The study lists 6 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 NCT04503018, 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.