Simulating Outcomes From Breast Conserving Surgery Using 3D Surface Imaging

NCT03250260 | Unknown

• 1 other identifier: CCR 4660
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer Female

Keywords

3-dimensional imaging; Breast Conserving Treatment; Simulation

Outcome Measures

Primary Outcomes (1)

• The difference between groups in the mean pre-operative Visual Analogue Scale.

  The mean VAS score (range: 0 -10mm) will be compared between groups. It is intended to assess preparedness for surgery of the women in each of the three arms. Patient scores in answer to the question "How confident are you that you know how your breasts are likely to look after treatment?" will be measured for each patient following randomisation and completion of their pre-operative preparation depending on study group.

  preoperatively

Secondary Outcomes (3)

• The differences in post-operative 'Satisfaction with Information' scores between the 3 groups

  preoperatively , 3 months and 12 months

• The difference in 'satisfaction with breasts' score pre and post-operatively between the 3 groups.

  preoperatively , 3 months and 12 months

• The difference in 'Quality of Life' score pre and post-operatively between the 3 groups.

  preoperatively , 3 months and 12 months

Other Outcomes (9)

• The difference in post-operative VAS score between groups.

  3 months and 12 months

• The differences in linear mammometrics between 3D-Simulation and post operative reality

  3 months and 12 months

• The differences in volume measurement between 3D-Simulation and post operative reality

  3 months and 12 months

Study Arms (3)

Standard Care

NO INTERVENTION

Patient receives standard pre-operative preparation which involves a discussion in to the likely aesthetic outcome with their surgeon or specialist nurse

2-dimensional Portfolio

EXPERIMENTAL

Patient views photographs of women matched for BMI, age, and breast volume who are 1-5 years post BCT pre-operatively.

Other: Viewing of a 2-dimensional photographic library

3-dimensional simulation

EXPERIMENTAL

Patient pre-operatively views a simulation of their own breast of their likely outcome after BCT.

Other: 3-dimensional photograph with simulation

Interventions

3-dimensional photograph with simulation OTHER

The viewing of a 3-dimensional simulation is classed as an intervention as it strays from the normal pre-operative preparation.

3-dimensional simulation

Viewing of a 2-dimensional photographic library OTHER

The viewing of a 2-dimensional photograph library is classed as an intervention as it strays from the normal pre-operative preparation.

2-dimensional Portfolio

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients Over 18 years Planned for unilateral breast conserving surgery at RMH Planned to receive adjuvant whole breast radiotherapy at RMH Willing to attend for study follow up visits.

You may not qualify if:

• Previous or concurrent surgery to the contralateral breast (previous breast conserving surgery, breast reduction or mastectomy)
• Previous surgery to the ipsilateral breast
• Unable to stand for long enough to have clinical photos (approximately 5 minutes)
• Unable to answer the BREAST-Q questionnaire (e.g. learning difficulties)
• Visually impaired (so that they could not view a 2D/3D images)
• Pre-operatively planning to have a symmetrisation procedure after radiotherapy.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

Royal Marsden Hospital

Sutton, Surrey, sm25pt, United Kingdom

RECRUITING

Related Publications (1)

• Godden AR, Micha A, Wolf LM, Pitches C, Barry PA, Khan AA, Krupa KDC, Kirby AM, Rusby JE. Three-dimensional simulation of aesthetic outcome from breast-conserving surgery compared with viewing photographs or standard care: randomized clinical trial. Br J Surg. 2021 Oct 23;108(10):1181-1188. doi: 10.1093/bjs/znab217.

  PMID: 34370833 DERIVED

Central Study Contacts

Jennifer E Rusby, BMBS, MD

CONTACT

02086613118; jennifer.rusby@rmh.nhs.uk

Amy R Godden, MBBS, BSc

CONTACT

02086426011; amy.godden@rmh.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised Controlled Trial

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: August 15, 2017
• Study Start: May 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2023
• Last Updated: August 15, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)