Clinical trial NCT06195865: Autologous vs. Implant-based Breast Reconstruction
Official title: Autologous vs. Implant-based Breast Reconstruction: a Partially Randomised Patient Preference, Superiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast reconstruction
DIEP-flap
Implant-based breast reconstruction
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Göteborg University
First posted: 2024-01-08
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

* ASA \> 2
* 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

Primary outcomes:
measure: Satisfaction with the breast/s and breast-specific quality of life
timeFrame: 5 years
measure: Cost-effectiveness
timeFrame: 5 years+ simulation model based on 20 years
Secondary outcomes:
measure: Complications
timeFrame: 5 years
measure: Surgical revisions
timeFrame: 5 years
measure: Satisfaction with the donor-site
timeFrame: 5 years
measure: Symptoms of depression and anxiety
timeFrame: 5 years
measure: Body image
timeFrame: 5 years
measure: Body investment
timeFrame: 5 years
measure: Generic quality of life
timeFrame: 5 years
Other outcomes:
measure: Expectations
timeFrame: Pre-op
measure: Patient's goals with the reconstruction
timeFrame: Pre-op
measure: Study with a trial (SWAT):The choice of breast reconstruction and the choice of reconstructive method.
timeFrame: Longitudinal - the same participants will be interviewed at allocation and 12 months after the reconstruction.
measure: Study with a trial (SWAT):What makes a participant very satisfied or very dissatisfied.
timeFrame: 12 months after reconstruction
measure: Study with a trial (SWAT): Experiences with the trial process.
timeFrame: Different participants from both cohorts are interviewed at allocation, 3 and 12 months to explore if there are different themes at different time points.
measure: Differences between the preference and the randomized cohort
timeFrame: Preoperatively and 12 months after reconstruction
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska university hospital
city: Gothenburg
country: Sweden
facility: Sahlgrenska university hospital
Study officials:
References: