Understanding the psychological effects of losing breast implants after reconstruction
Psychological Effects of Implant Loss
This study looks at how losing breast implants affects the feelings and quality of life of women who had breast reconstruction after cancer surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT04503018 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the psychological impact of implant loss on women who have undergone immediate breast reconstruction following mastectomy due to breast cancer. By focusing on patients' experiences, the study seeks to identify how such complications affect long-term satisfaction and quality of life. The findings may provide valuable insights that can guide clinical decisions regarding immediate versus delayed breast reconstruction in high-risk patients. The study will involve interviews and assessments of women who have experienced implant loss.
Who should consider this trial
Good fit: Ideal candidates for this study are biological women over 18 years old who have experienced implant loss after immediate breast reconstruction.
Not a fit: Patients who are unable to provide informed consent, do not speak or understand Swedish, or have psychiatric co-morbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance patient care by informing better decision-making regarding breast reconstruction options and preparing patients for potential complications.
How similar studies have performed: While there have been studies on quality of life in breast reconstruction, this specific focus on the psychological effects of implant loss is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Biological women * Age \>18 years * Have lost an implant after a mastectomy and immediate breast reconstruction Exclusion Criteria: * Inability to give informed consent * inability to speak and understand Swedish * relapse of breast cancer after the reconstruction * metastatic disease * psychiatric co-morbidity.
Where this trial is running
Gothenburg
- Västra Götaland — Gothenburg, Sweden (Recruiting)
Study contacts
- Principal investigator: Emma Hansson, PhD — Göteborg University
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.