Autologous vs. Implant-based Breast Reconstruction: a Partially Randomised Patient Preference, Superiority Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Vastra Gotaland Region
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Satisfaction with the breast/s and breast-specific quality of life
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
Although breast reconstruction is an integral part of breast cancer treatment, there is little high-quality evidence to indicate which method is the most effective. The objective of this study is to compare implant-based and autologous breast reconstruction, in non-radiated patients. The primary outcome is patient reported breast-specific quality of life/satisfaction and the secondary outcomes are complications, factors affecting satisfaction, and cost-effectiveness. Moreover, the study aims to improve the evidence for trial decision-making in breast reconstruction. Randomized controlled trials (RCT) are generally thought to provide the most solid scientific evidence, but there are significant barriers to conducting RCTs in breast reconstruction, making both recruitment and achieving unbiased and generalisable results a challenge. The study design partially randomised patient preference trial (RPPT) might be a way to overcome these challenges. In the present study, patients who consent to randomisation will be randomised to implant-based and autologous breast reconstruction, whereas patients with strong preferences will be able to choose method. The study is designed as a superiority trial based on BREAST-Q and 124 participants will be randomised. In the preference cohort patients will be included until 62 participants have selected the least popular alternative. Follow-up will be 60-months. Embedded qualitative studies and within-trial economic evaluation will be performed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Biological female
- •\>18 years of age
- •American Society of anesthesiologist classification (ASA) 1-2
- •Patient must have had or be scheduled for a mastectomy
- •Ability to give informed consent
- •Ability to communicate in Swedish
Exclusion Criteria
- •BMI \> 30 kg/m2
- •Smoking1 radiotherapy to the breast in question.
- •Radiotherapy is expected post-operatively.
- •Locally advanced breast cancer
- •Metastasised breast cancer
- •Comorbidity and/or drugs that affect wound healing.
- •Unstable psychiatric co-morbidity
- •Abdominal scaring/chest scaring making a DIEP/implant-based reconstruction unsuitable
Outcomes
Primary Outcomes
Satisfaction with the breast/s and breast-specific quality of life
Time Frame: 5 years
Satisfaction with the breast/s and breast-specific quality of life measured with BREAST-Q reconstruction.The patient rates all items on 3-, 4-, and 5-point Likert-scales. A raw score, that is converted to a score 0-100, is calculated for each domain. A higher score indicates a greater satisfaction or better quality of life.
Cost-effectiveness
Time Frame: 5 years+ simulation model based on 20 years
The net cost divided for society by changes in health outcomes measured with Breast-Q and EQ5D.
Secondary Outcomes
- Complications(5 years)
- Satisfaction with the donor-site(5 years)
- Surgical revisions(5 years)
- Symptoms of depression and anxiety(5 years)
- Generic quality of life(5 years)
- Body image(5 years)
- Body investment(5 years)