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.
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Recruitment Rate to a study of this design
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •<1 year or over 5 years from surgery
- •Explantation
- •Local or distant recurrence
- •Lacks capacity
结局指标
主要结局
Recruitment Rate to a study of this design
时间窗: 3 months
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.
次要结局
- 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)
- 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?(6 months)
- To assess the feasibility of online patient satisfaction and quality of life questionnaires.(6 months)