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

doi:10.1136/bmjopen-2019-029468

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

Cancer and Genomic Sciences

Research output: Contribution to journal › Article › peer-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 language	English
Article number	e029468
Journal	BMJ open
Volume	9
Issue number	9
DOIs	https://doi.org/10.1136/bmjopen-2019-029468
Publication status	Published - 26 Sept 2019

Bibliographical note

Keywords

bladder cancer
prospective cohort study
randomised controlled trial
trials within cohorts

ASJC Scopus subject areas

General Medicine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1136/bmjopen-2019-029468Licence: Creative Commons: Attribution-NonCommercial (CC BY-NC)

Wylie_et_al_Graham_Roberts_Study_protocol_first_'trials_within_cohort_study'_for_bladder_cancer_BMJ_open_2019
Wylie H, Cahill F, Santaolalla A, et alGraham Roberts Study protocol: first ‘trials within cohort study’ for bladder cancerBMJ Open 2019;9:e029468. doi: 10.1136/bmjopen-2019-029468
Final published version, 251 KBLicence: Creative Commons: Attribution-NonCommercial (CC BY-NC)

https://bmjopen.bmj.com/content/9/9/e029468Licence: Creative Commons: Attribution-NonCommercial (CC BY-NC)

Cite this

Wylie, H., Cahill, F., Santaolalla, A., Moss, C. L., Enting, D., Amery, S., Chatterton, K., Khan, M. S., Bryan, R. T., Gillett, C., Josephs, D., Chowdhury, S., Rudman, S., Hughes, S., Relton, C., & Van Hemelrijck, M. (2019). Graham Roberts Study protocol: first 'trials within cohort study' for bladder cancer. BMJ open, 9(9), Article e029468. https://doi.org/10.1136/bmjopen-2019-029468

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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.",

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

note = "{\textcopyright} 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.",

year = "2019",

month = sep,

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AU - Cahill, Fidelma

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AU - Moss, Charlotte Louise

AU - Enting, Deborah

AU - Amery, Suzanne

AU - Chatterton, Kathryn

AU - Khan, Muhammad Shamim

AU - Bryan, Richard T

AU - Gillett, Cheryl

AU - Josephs, Debra

AU - Chowdhury, Simon

AU - Rudman, Sarah

AU - Hughes, Simon

AU - Relton, Clare

AU - Van Hemelrijck, Mieke

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N2 - 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.

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

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

UN SDGs

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