Pilot Study for 3-Dimensional Surface Imaging in Implant-based Breast Reconstruction
NCT ID: NCT03203252
Last Updated: 2017-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2017-06-09
2017-08-30
Brief Summary
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Detailed Description
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Methods At The Royal Marsden Hospital in Sutton 125 implant-based reconstructions are performed per year (data from 2014). The study team would like to invite women who have had their treatment within the previous 1-5 years to participate in the pilot. The women can be identified through operation records. The study team will aim to include 50.
A letter of invitation will be sent by post. This will include a participant information leaflet, a link to the website, and a unique study ID for each participant. In recent studies, more than 8 out of ten women who were asked to participate agreed.
The website will have the following features:
* Patient study information including links to other relevant information sources (e.g. ABS, Breast Cancer Care, RMH, ICR, BRC), patient testimonials, and biographies from the study team.
* An online consent process for the study.
* A questionnaire for patient demographics (height, weight etc)and treatment information (i.e. type of operation and other treatments like radiotherapy).
* An online version of the BREAST-Q reconstruction module and radiotherapy module from the breast conserving surgery BREAST-Q (a questionnaire designed to assess quality of life and satisfaction with care for patients having breast surgery).
* An online calendar to book a 3D-SI appointment at the hospital.
* A user survey to gain patient feedback on the website and the concept of online consent.
* A 'contact us' section in case further information is required.
At each stage the participant will enter their unique study ID so all of the information collected will remain anonymous. We will hold the code for study IDs securely. There is no patient identifiable data collected on the website. The participant will be guided through the different aspects of the online recruitment processes outlined above. When they have read the patient information, they can click on the link to consent to the study at which point a check screen will ask:
1. I have had enough information and wish to consent to the study - link to the consent form
2. I would like further information which is not available on the website - link to contact us section
Only then will they be able to access the data collection stages of the website and book a photography slot, thereby we can be sure that no patient starts to enter information or attends for a photograph without valid consent.
Following this the participant will be required to attend the hospital only once for an appointment (booked online) for a 3D photograph and height and weight measurement. This will take less than 20 minutes. This will be the end of the patient involvement in the study.
Success in this pilot will provide:
* A bespoke website to facilitate online patient education, consent, and data collection to streamline research processes.
* Information on uptake rate and specific evaluation of the acceptability of the web system and accuracy of patient entered data.
* Data on the accuracy of the VECTRA software to measure implant base reconstruction.
* A secure online 3D-SI storage facility to enable access from multiple hospitals to enable wider involvement in large scale research.
* A library of 3D-surface images on which to base a panel assessment score for implant-based reconstruction by way of a consensus meeting at the outset of the future multi-centre study.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Interventions
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Reconstruction BREAST-Q
Validated Patient reported outcome measure specifically designed to assess Quality of life domains and satisfaction following breast reconstruction.
3-dimensional Surface Image
Non-invasive 3-dimensional photograph using VECTRA® XT 3D imaging system.
Treatment Questionnaire
Online questionnaire pertaining to treatment received pertaining to breast cancer or risk reduction for breast cancer.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* Explantation
* Local or distant recurrence
* Lacks capacity
18 Years
FEMALE
No
Sponsors
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Royal Marsden NHS Foundation Trust
OTHER
Responsible Party
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Locations
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Royal Marsden Hospital
Sutton, Surrey, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Julie Curtis
Role: primary
References
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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
Pusic 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.
Godden 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.
Related Links
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BREAST-Q Information
Other Identifiers
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CCR4707
Identifier Type: -
Identifier Source: org_study_id