Graham Roberts Study protocol: first 'trials within cohort study' for bladder cancer

Research output: Contribution to journalArticle

Authors

  • Harriet Wylie
  • Fidelma Cahill
  • Aida Santaolalla
  • Charlotte Louise Moss
  • Deborah Enting
  • Suzanne Amery
  • Kathryn Chatterton
  • Muhammad Shamim Khan
  • Cheryl Gillett
  • Debra Josephs
  • Simon Chowdhury
  • Sarah Rudman
  • Simon Hughes
  • Clare Relton
  • Mieke Van Hemelrijck

Colleges, School and Institutes

External organisations

  • Urology, Guy's & St Thomas' Hospital, London, UK.
  • King's College London
  • Queen Mary University of London
  • Guy's and Saint Thomas' NHS Foundation Trust

Abstract

INTRODUCTION: Given the need for more bladder cancer research and the recently observed advantages of introducing the trials within cohort (TwiCs) design, the set-up of the Graham Roberts Study (Roberts Study) will provide valuable infrastructure to answer a wide variety of research questions of a clinical, mechanistic, as well as supportive care nature in the area of bladder cancer.

METHODS: Using the TwiCs design, we will recruit patients aged 18 or older who are willing and able to provide signed informed consent and have a diagnosis of new or recurrent bladder cancer into this prospective cohort study. All patients must have a basic understanding of the English language. The following questionnaires will be collected at baseline and every 12 months subsequently: Functional Assessment of Chronic Illness Therapy for Bladder Cancer, the Functional Assessment of Chronic Illness Therapy-Fatigue, the Patient Heath Questionnaire-9, the standardised instrument for a generic health status (EQ-5D-5L), a Short Questionnaire to Assess Health-Enhancing Physical Activity and the Hertfordshire Short Questionnaire to Assess Diet Quality.

ETHICS AND DISSEMINATION: Due to the nature of this study, we obtained full ethical clearance from the London-Fulham Research Ethics Committee (17/LO1975). All participants must provide full informed consent before recruitment onto the study. The results of this study will be published in peer-reviewed journals and data collected as part of the study will be made available to potential collaborators on an application basis.

Bibliographic note

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Details

Original languageEnglish
Article numbere029468
JournalBMJ open
Volume9
Issue number9
Publication statusPublished - 26 Sep 2019

Keywords

  • bladder cancer, prospective cohort study, randomised controlled trial, trials within cohorts

ASJC Scopus subject areas