MIBREAST Making in Immediate Breast REconstruction And the Measurement of the EffectS of RadioTherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The IMpact of 3D Surface Imaging and Simulation on Shared Decision Making in Immediate Breast REconstruction And the Measurement of the EffectS of RadioTherapy
Overview
Patients who require a removal of a breast (mastectomy) for breast cancer or future risk reduction often have immediate breast reconstruction (IBR). This can be performed using either an implant or the patient's own body fat to recreate the breast shape. Patients can find it difficult to imagine their own post-surgery appearance. Using 3D surface imaging (3D-SI) can change a patient's pictures to show them how they might look after surgery, known as a simulation. Some patients may find 3D-SI and simulation gives them confidence in their expectations and others may not feel it helps much. This study will investigate the following 3 questions: 1. Whether 3D-SI and simulation can improve patient confidence about their likely post-surgery appearance 2. Whether 3D-SI measurement of breast shape helps in surgical planning and reduces the need for later adjustment surgery to improve symmetry, especially in patients having a mastectomy on one side only 3. How much radiotherapy changes breast reconstructions over time using 3D- SI to objectively measure this. For this study the follow up for some women who do and some who do not have radiotherapy after breast reconstruction. 3D surface imaging may improve surgeon understanding of breast shape, prior to surgery. In cases where there is a high risk of breast cancer recurrence patients are offered radiotherapy to the breast, either before or after surgery. Radiotherapy has a negative impact on the reconstructed breast, and may cause it to shrink and change position but the effect of radiotherapy has never been accurately quantified. This study will be investigating the following: 1. Whether 3D-SI measurement of breast shape helps in surgical planning and reduces the need for later adjustment surgery to improve symmetry, especially in patients having a mastectomy on one side only 2. How much radiotherapy changes breast reconstructions over time using 3D- SI to objectively measure this. For this study the follow up some women who do and some who do not have radiotherapy after breast reconstruction.
Detailed description
Approximately 40% of all women diagnosed with breast cancer (BC) will require a mastectomy and a large proportion (60%) of these will choose to have an immediate breast reconstruction (IBR).
Patient satisfaction with physical appearance after completion of their BC treatment has a well-documented association not only with their psychological wellbeing but also improved quality of life. Due to advances in oncological therapies, BC patients now have excellent survival rates of 85% at five years and 75% at ten years meaning that more women survive to experience the long-term impact of surgical and radiotherapy treatments and highlights the importance of improving aesthetic outcome as a survivorship focus.
3D-surface imaging (3D-SI) and simulation is frequently used to demonstrate cosmetic breast augmentation outcomes in the private sector and is increasingly being used in breast cancer surgery.
Effective communication of the post-operative aesthetic outcome and the possible requirement of adjustment surgery to patients is a central part of the informed consent process. Women sometimes struggle to decide between breast-conserving treatment and mastectomy with or without reconstruction. Those that want reconstruction to have the option of using a silicone implant, or their own tissue, transplanted from the abdomen or inner thigh (an autologous flap). Consultations focus on the patient's desires and expectations, and the surgeon's explanation of what is technically possible, the benefits and compromises, until a mutual understanding is reached. This can however be challenging, particularly when attempting to predict the effects of adjuvant radiotherapy on the reconstructed breast. Traditionally, surgeons have used diagrams or 2D clinical photographs of other patients who have had surgery to demonstrate the predicted post-operative appearance. Many patients have reported that they find these methods unhelpful and confusing, as the wide variety of body habitus, breast shape, skin tone and surgical options mean that it is unlikely that a woman will see images adequately illustrating her own unique outcome.
The hypothesise that viewing 3D simulations of their own likely appearance after mastectomy and breast reconstruction will give women more confidence and certainty as they approach surgery. There are not yet in a position to use 3D-SI as a decision-support tool.
The overarching aim of this study is to evaluate the utility of 3D-SI in simulation and measurement of outcome of immediate breast reconstruction.
Hypothesis 1 - Impact of 3D Simulation on Shared Decision Making Women who see a simulation of their IBR outcome will have more confidence in their decision-making about IBR options.
Hypothesis 2 - Impact of 3D-SI on Elective Surgical Revision rate A better understanding of breast shape may reduce the need for elective surgical revisions such as volume-adjustment procedures (lipofilling or liposuction) in the reconstructed breast.
Hypothesis 3 - Impact of Radiotherapy on IBR The hypothesise that immediate breast reconstructions that receive radiotherapy undergo greater change in shape and position over time.
Primary outcome measures
- Difference in Visual Analogue Scale Score [Time frame: Preioperative/Periprocedural]
Secondary outcome measures (9)
- Difference in decisional conflict scale score [Time frame: Perioperative/Periprocedural]
- Comparison between 3D and SoC anthropometric measurements [Time frame: Perioperative/Periprocedural]
- Thematic analysis of surgeons' experience [Time frame: 1 year]
- Evaluation of actual outcome against simulated appearance by panel assessment using a Likert scale [Time frame: through study completion, an average of 1 year]
- Comparison of patient satisfaction with the breast, and with information given (BREAST-Q domains) by randomisation group [Time frame: through study completion, an average of 1 year]
- Using 3D-SI to classify breast shape [Time frame: through study completion, an average of 1 year]
- Impact of breast shape classification on elective secondary revisions (ESRs) and reconstructive outcomes [Time frame: through study completion, an average of 1 year]
- Documented relationship between donor tissue availability and breast volume [Time frame: through study completion, an average of 1 year]
- Documented changes in shape of IBR with and without radiotherapy [Time frame: through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- Female
- Aged > 18
- Undergoing immediate breast reconstruction (autologous or implant based) follow mastectomy for breast cancer or as a risk-reducing strategy
- Available to attend 3D-SI appointments at specified intervals
Exclusion criteria
- Lack of capacity
- Language barrier that prevents patients from understanding the English questionnaires
- Visual impairment
- Unable to answer study questionnaires
- Disability that may prevent appropriate positioning during the imaging process
- Unable to attend for photography
- Requiring delayed reconstruction or no longer considering a reconstruction
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Royal Marsden NHS Foundation Trust — London
Identifiers
NCT: NCT07136753 · CCR5635