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

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

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)
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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.

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

Keywords

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

ASJC Scopus subject areas

  • Medicine(all)

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