Patient Reported Outcomes in Gestational Trophoblastic Disease
Research type
Research Study
Full title
An evaluation of a new online patient reported outcome measure (PROM) within a rare cancer in the United Kingdom (UK): establishing a national validated PROM within the UK Gestational Trophoblastic Disease (GTD) Service to improve patient care and support a new era of virtual clinics for GTD patients.
IRAS ID
260470
Contact name
Jane / JR Ireson
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS FT
Duration of Study in the UK
3 years, 2 months, 26 days
Research summary
When women become pregnant they are at risk of developing Gestational Trophoblastic Disease, or GTD. GTD is a rare condition that can develop into cancer. Three centres in London, Sheffield and Dundee are responsible for the monitoring and treatment of GTD in the United Kingdom (UK).\n\n\nThe Problem\nMost GTD patients only send urine or blood samples from home because they live a long way from a specialist centre. Within this group are new GTD patients being monitored for signs of cancer, and survivors being monitored for the cancer coming back. The GTD services do not routinely ask these women how they feel, emotionally or physically, or how GTD is affecting their life. Recent work found that little is known about the effect of GTD on women’s lives. \n\nWhat we will do\nWe have developed a new electronic questionnaire with nine GTD patients (ePAQ-GTD). The questionnaire can be completed electronically at home or hospital. It asks women with GTD important questions about the effects of GTD and its treatment on their lives. For example, it asks about the anxiety caused by fertility issues. A GTD specialist will then use the results of urine/blood tests and ePAQ-GTD to conduct a virtual clinic. \n\nThe aims of this research are to evaluate ePAQ-GTD as part of routine care. We also want to learn about the impact of GTD on women’s lives.\n\nThe research will involve three stages and use two different approaches (called quantitative and qualitative methods). In stage 1 the quality of ePAQ-GTD will be tested to make sure it has the right number of easy to understand questions. In stage 2, we plan to use the questionnaire in all three GTD centres. In stage 3 we will talk to women and GTD specialists about their experience of using ePAQ-GTD.\n\n
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
20/YH/0043
Date of REC Opinion
14 Jul 2020
REC opinion
Further Information Favourable Opinion