Autologous vs. Implant-based Breast Reconstruction

Breast Cancer Clinical Trial

— GoBreast II  

Official title:

Autologous vs. Implant-based Breast Reconstruction: a Partially Randomised Patient Preference, Superiority Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06195865
• Other study ID #: 2023-04754-01
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 31, 2031

Study information

• Verified date: April 2024
• Source: Vastra Gotaland Region
• Contact: Emma Hansson, PhD
• Phone: +46313421000
• Email: emma.em.hansson[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2031
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• DIEP-flap
Breast reconstruction with a deep inferior epigastric perforator flap
• Implant
Breast reconstruction with an implant-based technique

Locations

Country	Name	City	State
Sweden	Sahlgrenska university hospital	Gothenburg
Sweden	Sahlgrenska university hospital	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Vastra Gotaland Region	Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Expectations	Pre-operative expectations will be measured with the BREAST-Q expectations domain. 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.	Pre-op
Other	Patient's goals with the reconstruction	patient's goals with the reconstruction will be documented using the PEGASUS instrument. Patients' Expectations and Goals of reconstruction. Assisting Shared Understanding of Surgery) tool to make the decision of whether they want a breast reconstruction. The tool is used to form a basis for a patient-centred dialogue around breast reconstruction.	Pre-op
Other	Study with a trial (SWAT):The choice of breast reconstruction and the choice of reconstructive method.	Qualitative study - participants will be recruited from the preference cohort.	Longitudinal - the same participants will be interviewed at allocation and 12 months after the reconstruction.
Other	Study with a trial (SWAT):What makes a participant very satisfied or very dissatisfied.	Qualitative study -Participants will be recruited from both cohorts among women who scored high/low, compared to the mean, on BREAST-Q outcome and satisfaction with breast/s.	12 months after reconstruction
Other	Study with a trial (SWAT): Experiences with the trial process.	Qualitative study -How the participant experienced the trial process, how it can be ameliorated to increase recruitment, retention, and follow-up rates of questionnaires and how participation information leaflet should be designed/written to maximize recruitment.	Different participants from both cohorts are interviewed at allocation, 3 and 12 months to explore if there are different themes at different time points.
Other	Differences between the preference and the randomized cohort	Differences regarding demographic factors as well as pre-operative satisfaction with breasts, expectations, body-image, symptoms of depression and anxiety, and generic quality of life.	Preoperatively and 12 months after reconstruction
Primary	Satisfaction with the breast/s and breast-specific quality of life	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.	5 years
Primary	Cost-effectiveness	The net cost divided for society by changes in health outcomes measured with Breast-Q and EQ5D.	5 years+ simulation model based on 20 years
Secondary	Complications	Complications classified as types and according to the Clavien-Dindo Classification (CDC) of surgical complications. According to CDC all complications are graded from 1 (any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions) to 5 (Patient demise). Comprehensive Complication Index (CCI) scores will also be used. The CCI is calculated from CDC as the sum of all complications that are weighted for their severity, yielding a scale from 0-100. A higher CCI means more severe and more complications. All participating surgeons will be given a list of study specific definitions of complications.	5 years
Secondary	Surgical revisions	All operations performed will be recorded and classified according to the international classification of disease in the operation planing program Orbit.	5 years
Secondary	Satisfaction with the donor-site	Satisfaction with the donor site will be measured with the abdominal domain of Breast-Q.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.	5 years
Secondary	Symptoms of depression and anxiety	Symptoms of depression and anxiety will be measured with the Hospital Anxiety and Depression Scale (HADS).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.	5 years
Secondary	Body image	Body image will be measured with the Multidimensional Body-Self Relation Questionnaire (MBSRQ).Multidimensional body-self relations questionnaire- appearance scales.It is a 34-item self-report questionnaire designed to measure appearance related components of body-image. In consists of five subscales: appearance evaluation, appearance orientation, body areas satisfaction, overweight preoccupation, and self-classified weight. It is a 5-point Likert-scale ranging from 1 to 5.	5 years
Secondary	Body investment	Body investment will be measured with the Appearance Schemas Inventory-revised (ASI-R).Appearance schemas inventory-revised: is a 20-item self-report questionnaire designed to measure body-image investment. It consists of two subscales, self-evaluative salience (SES) and motivational salience (MS). It is a 5-point Likert-scale ranging from 1 (strongly disagree) to 5 (strongly agree). Twelve items relate to SES and eight items relate to MS. The total score is the mean of the 20 items, and the score of the subscales is the mean of the items relating to each subscale. A high score indicates greater body-image investment.	5 years
Secondary	Generic quality of life	Generic quality of life will be measured with EuroQoL-5 dimensions (EQ-5D-3L).n EQ-5D-3L, the five dimensions each have three response levels of severity.Respondents are asked to choose the statement in each dimension that best describes their health status on the day they are surveyed. Their responses are coded as a number (1, 2, or 3) that corresponds to the respective level of severity: 1 indicates no problems, 2 some problems, and 3 extreme problems.	5 years