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Oncology
Protocol
Graham Roberts Study protocol: first ‘trials within cohort study’ for bladder cancer
  1. Harriet Wylie1,
  2. Fidelma Cahill1,
  3. Aida Santaolalla1,
  4. Charlotte Louise Moss1,
  5. Deborah Enting1,2,
  6. Suzanne Amery3,
  7. Kathryn Chatterton3,
  8. Muhammad Shamim Khan4,
  9. Richard T Bryan5,
  10. Cheryl Gillett6,
  11. Debra Josephs1,2,
  12. Simon Chowdhury1,2,
  13. Sarah Rudman1,2,
  14. Simon Hughes1,2,
  15. Clare Relton7,8,
  16. Mieke Van Hemelrijck1
  1. 1 Translational Oncology and Urology Research, King’s College London, London, UK
  2. 2 Department of Medical Oncology, Guy’s and Saint Thomas’ NHS Foundation Trust, London, UK
  3. 3 Urology Centre, Guy’s and Saint Thomas’ NHS Foundation Trust, London, UK
  4. 4 Urology, Guy’s & St Thomas’ Hospital, London, UK
  5. 5 Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK
  6. 6 King’s Health Partners Cancer Biobank, King’s College London, London, UK
  7. 7 ScHARR, University of Sheffield, Sheffield, UK
  8. 8 Blizard Institute, Queen Mary University of London, London, UK
  1. Correspondence to Charlotte Louise Moss; charlotte.moss{at}kcl.ac.uk

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.

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

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2019-029468

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    Footnotes

    • Contributors MVH, FC, HW, CR, CLM and AS designed the study with input from their clinical colleagues (SC, SH, SR, DE, DJ, RTB, SA, KC, MSK) and the biobank coordinator (CG). All authors read and approved the final manuscript.

    • Funding Funding to conduct the study is kindly provided by the Graham and Dianne Roberts Charitable Settlement.

    • Disclaimer The funders had no role in the design of the study and collection, analysis and interpretation of data nor in writing of the manuscript.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Ethics approval The study will be conducted in compliance with the principles of the Declaration of Helsinki (1996), the principles of GCP and in accordance with all applicable regulatory requirements including but not limited to the Research Governance Framework and the Medicines for Human Use (Clinical Trial) Regulations 2004, as amended in 2006 and any subsequent amendments. This protocol and related documents were approved by the London–Fulham Research Ethics Committee as part of gaining Health Research Authority approval (17/LO/1975). After completion of an RCT within the Roberts Study, all patients—irrespective of participation in the specific study—will receive aggregated results via a newsletter that they can subscribe to at time of initial consent. The results of this study will be published in peer-reviewed journals.

    • Provenance and peer review Not commissioned; externally peer reviewed.