Clinical trial NCT03203252: Pilot Study for 3-Dimensional Surface Imaging in Implant-based Breast Reconstruction
Official title: 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: Aim To test the feasibility of a number of novel initiatives prior to their use in a multi-centre study. The future study will develop a way to measure cosmetic outcome for implant-based breast reconstruction using 3-dimensional Surface Imaging (3D-SI).

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* \<1 year or over 5 years from surgery
* Explantation
* Local or distant recurrence
* Lacks capacity

Primary outcomes:
measure: Recruitment Rate to a study of this design
timeFrame: 3 months
Secondary outcomes:
measure: To understand dropout rates
timeFrame: 6 months
measure: To understand how long it takes to complete the online recruitment process.
timeFrame: 6 months
measure: To understand reasons for not completing the online process once started.
timeFrame: 6 months
measure: To analyse how accurately participants report data pertaining to their medical treatment and themselves (eg height and weight/use of radiotherapy)
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
measure: To assess the feasibility of an online secure storage facility for 3D surface images i.e. how long it takes to upload and evaluate the images, how user-friendly is it?
timeFrame: 6 months
measure: To assess the feasibility of online patient satisfaction and quality of life questionnaires.
timeFrame: 6 months
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: Surrey
Study officials:
References:
citation: 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
citation: 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.
citation: 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.