NCT03250260

Simulating Outcomes From Breast Conserving Surgery Using 3D Surface Imaging

Status unknown NA Last updated 15 August 2017

What this trial tests

NA trial testing 3-dimensional photograph with simulation in Breast Cancer Female in 117 participants. Status unknown.

Timeline

1 May 2017

Primary endpoint
31 December 2018

31 December 2023

Quick facts

Lead sponsor	Royal Marsden NHS Foundation Trust
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	117
Start date	1 May 2017
Primary completion	31 December 2018
Estimated completion	31 December 2023
Sites	1 location across United Kingdom

Drugs / interventions tested

• 3-dimensional photograph with simulation
• Viewing of a 2-dimensional photographic library

Conditions studied

• Breast Cancer Female — all drugs for Breast Cancer Female →

Sponsor

Royal Marsden NHS Foundation Trust

Who can join

18 and older, female only, with Breast Cancer Female. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Most women with breast cancer are able to have an operation to remove the cancer while preserving the breast (breast conserving therapy, BCT). Whilst cancer control is the most important goal, appearance of the breast after surgery has been shown to affect the quality of a woman's life after treatment. This is even more relevant now that most women are surviving breast cancer.

Before surgery, women are prepared for how they will look afterwards by having a discussion with the Surgeon or Breast Care Nurse. Sometimes women are shown two dimensional (2D) (standard) photographs of other women who had a similar operation. Patients have stated that viewing photographs of other patients does not prepare them adequately for their own experience of surgery.

Three dimensional (3D) digital photography is currently being used to predict the appearance of the breasts after enlargement surgery using specialist software. The investigators intend to use a similar system to simulate a patient's appearance after BCT for cancer. The investigators believe that this will lead women to feel better prepared for their surgery, reduce stress, and lead to greater satisfaction with their breast after treatment.

This study invites women undergoing BCT to be assigned at random to one of three groups receiving standard care (discussion), a 2D photograph, or the 3D simulation before their operation. The investigators will find out whether women feel better prepared for surgery and are more satisfied with their outcome if they are shown a simulated image of how their own breasts are likely to look.

By taking 3D photographs of all study patients before and after surgery, a more accurate way to predict appearance after surgery will be developed for future patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Three-dimensional simulation of aesthetic outcome from breast-conserving surgery compared with viewing photographs or standard care: randomized clinical trial.
   Godden AR, Micha A, Wolf LM, Pitches C, et al · · 2021 · cited 9× · PMID 34370833 · DOI 10.1093/bjs/znab217