About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Lack of capacity
Language barrier that prevents patients from understanding the English questionnaires
Visual impairment
Unable to answer study questionnaires
Trial population
Patients considering breast reconstruction following mastectomy for cancer or risk reduction.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Difference in Visual Analogue Scale Score
Difference in mean visual analogue scale (VAS) for the question 'How confident is one in knowing how their breasts are likely to look after treatment?' VAS score is on a scale from 0-10 (0 indicates not at all confident and 10 indicates very confident)
Secondary outcomes
Difference in decisional conflict scale score
Difference in Decisional Conflict Scale (DCS) score for women who see and do not see their simulated reconstruction
Comparison between 3D and SoC anthropometric measurements
Comparison between Crisalix and routine tape measure anthropometric measurements.The same unit of measurement will be used for the anthropometric distances (i.e.sternal notch to nippple, nipple to nipple, nipple to midline, nipple to lateral fold, nipple to inframammary fold and breast diameter) measured in cm for both 3D-SI and tape measurements
Thematic analysis of surgeons' experience
Thematic analysis of surgeons' experience
Evaluation of actual outcome against simulated appearance by panel assessment using a Likert scale
Evaluation of the actual outcome against the simulated appearance
Sponsors and contacts
Click on the lead sponsor to view all of their trials.