Examining the impact of expectations and body image on breast reconstruction outcomes
Official title: Psychological Effect of Expectations and Body Image on Outcomes of Breast Reconstruction
Run by Vastra Gotaland Region · NCT04714463 · Data updated 2026-11-12
This study is trying to see how women's expectations and feelings about their bodies affect the results of breast reconstruction after mastectomy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 500 (estimated) |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Gothenburg) |
| Status | Recruiting |
| Started | February 1, 2021 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 3, 2025 |
| Trial ID | NCT04714463 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include biological women over 18 years old with breast cancer or a high risk for breast cancer who are seeking post-mastectomy breast reconstruction.
✕Probably not a fit
Patients who may not benefit include those unable to give informed consent, those with a cancer relapse, or those receiving palliative treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates how patient expectations and body image influence the outcomes of breast reconstruction following mastectomy due to breast cancer or high cancer risk. It aims to enhance preoperative information and postoperative care by understanding which women truly benefit from breast reconstruction. The study will involve biological women over 18 years old who are considering breast reconstruction, focusing on their psychosocial adjustment and quality of life. Various reconstruction methods, including implant-based and autologous techniques, will be assessed in relation to patient-reported outcomes.
Why it matters
Potential benefit: If successful, this study could lead to improved patient satisfaction and quality of life for women undergoing breast reconstruction.
How similar studies have gone: While there have been studies on psychosocial adjustment in breast cancer patients, this specific focus on expectations and body image in relation to breast reconstruction outcomes is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Biological women with breast cancer or high risk for breast cancer who want post-mastectomy breast reconstruction * Age \> 18 years Exclusion Criteria: * Inability to give informed consent * Inability to understand Swedish * Relaps of cancer * Palliative treatment
Where it's running
-
Sahlgrenska university hospital
Gothenburg, Sweden Recruiting
Study contacts
- Principal investigator: Emma Hansson, PhD — Göteborg University
- Study coordinator: Emma Hansson, PhD
- Email: emma.em.hansson@vgregion.se
- Phone: +46313421000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Gyrotonic exercise for elders with breast cancer and Behcet disease
We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.
-
PECS II vs SPSIP nerve blocks for pain after mastectomy
This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
-
Compare a new endoscopy-assisted breast-conserving surgery with the usual approach
This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.
-
Different skin care approaches to prevent skin reactions after mastectomy radiation
This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.
-
3D Heart Strain to Detect Early Cardiotoxicity in Cancer Therapy
This study tests whether 3D echocardiography can detect early heart damage from cancer treatments like anthracyclines or HER2-targeted therapy better than standard 2D methods.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.