Pilot Study for 3-Dimensional Surface Imaging in Implant-based Breast Reconstruction
3D-SI
Pilot Study Towards Development of an Objective Evaluation of Outcome After Implant-based Breast Reconstruction, Using 3D-surface Imaging (3D-SI) and the Feasibility of a Novel Online Research Tool.
1 other identifier
observational
50
1 country
1
Brief Summary
Measuring appearance of implant-based breast reconstruction after mastectomy for breast cancer - an online approach to research. Using 3-dimensional surface images we intend to create a tool to measure appearance after surgery in order to improve standards of care for women. We want to minimise the number of visits and amount of time involved in research participation so this pilot study will develop new online tools for information giving and gathering, and for consent so that only one visit to hospital will be required for photographs. This will also extend the availability of expensive 3D technology to more women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 9, 2017
CompletedFirst Submitted
Initial submission to the registry
June 15, 2017
CompletedFirst Posted
Study publicly available on registry
June 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2017
CompletedJune 29, 2017
June 1, 2017
3 months
June 15, 2017
June 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Recruitment Rate to a study of this design
The study team will assess the number of participants as a proportion of those approached. The study team will assess the proportion of those approached versus those who complete the recruitment process by attending for their 3D-SI.
3 months
Secondary Outcomes (7)
To understand dropout rates
6 months
To understand how long it takes to complete the online recruitment process.
6 months
To understand reasons for not completing the online process once started.
6 months
To analyse how accurately participants report data pertaining to their medical treatment and themselves (eg height and weight/use of radiotherapy)
6 months
To assess inter- and intra-observer variability in a range of objective measurements to enable us to choose those to measure in the multi-centre study.
6 months
- +2 more secondary outcomes
Interventions
Validated Patient reported outcome measure specifically designed to assess Quality of life domains and satisfaction following breast reconstruction.
Non-invasive 3-dimensional photograph using VECTRA® XT 3D imaging system.
Online questionnaire pertaining to treatment received pertaining to breast cancer or risk reduction for breast cancer.
Eligibility Criteria
This is an observational study of female participants who have undergone mastectomy and implant-based reconstruction within the last 1-5 years. The research will be carried out at the Royal Marsden NHS Foundation Trust Sutton.
You may qualify if:
- Female patients
- Over 18 years
- Have undergone implant-based reconstruction 1-5 years before study entry (can be unilateral or bilateral, immediate or delayed, nipple-sparing or nipple-sacrificing, risk reducing or therapeutic)
You may not qualify if:
- \<1 year or over 5 years from surgery
- Explantation
- Local or distant recurrence
- Lacks capacity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Marsden Hospital
Sutton, Surrey, sm25pt, United Kingdom
Related Publications (3)
Pusic et al. Measuring Quality of Life in Breast Surgery: Content development of a new modular system to capture patient reported outcomes (The MSKCC BREAST-Q). ISOQOL Annual Meeting. October 2006 Lisbon, Portugal
BACKGROUNDPusic AL, Chen CM, Cano S, Klassen A, McCarthy C, Collins ED, Cordeiro PG. Measuring quality of life in cosmetic and reconstructive breast surgery: a systematic review of patient-reported outcomes instruments. Plast Reconstr Surg. 2007 Sep 15;120(4):823-837. doi: 10.1097/01.prs.0000278162.82906.81.
PMID: 17805107RESULTGodden AR, Wood SH, James SE, MacNeill FA, Rusby JE. A scoring system for 3D surface images of breast reconstruction developed using the Delphi consensus process. Eur J Surg Oncol. 2020 Sep;46(9):1580-1587. doi: 10.1016/j.ejso.2020.05.016. Epub 2020 Jun 7.
PMID: 32620404DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2017
First Posted
June 29, 2017
Study Start
June 9, 2017
Primary Completion
August 30, 2017
Study Completion
August 30, 2017
Last Updated
June 29, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share