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Graham Roberts Study protocol: first ‘trials within cohort study’ for bladder cancer
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 c...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6773355/ https://www.ncbi.nlm.nih.gov/pubmed/31558452 http://dx.doi.org/10.1136/bmjopen-2019-029468 |
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author | Wylie, Harriet Cahill, Fidelma Santaolalla, Aida Moss, Charlotte Louise Enting, Deborah Amery, Suzanne Chatterton, Kathryn Khan, Muhammad Shamim Bryan, Richard T Gillett, Cheryl Josephs, Debra Chowdhury, Simon Rudman, Sarah Hughes, Simon Relton, Clare Van Hemelrijck, Mieke |
author_facet | Wylie, Harriet Cahill, Fidelma Santaolalla, Aida Moss, Charlotte Louise Enting, Deborah Amery, Suzanne Chatterton, Kathryn Khan, Muhammad Shamim Bryan, Richard T Gillett, Cheryl Josephs, Debra Chowdhury, Simon Rudman, Sarah Hughes, Simon Relton, Clare Van Hemelrijck, Mieke |
author_sort | Wylie, Harriet |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-6773355 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-67733552019-10-21 Graham Roberts Study protocol: first ‘trials within cohort study’ for bladder cancer Wylie, Harriet Cahill, Fidelma Santaolalla, Aida Moss, Charlotte Louise Enting, Deborah Amery, Suzanne Chatterton, Kathryn Khan, Muhammad Shamim Bryan, Richard T Gillett, Cheryl Josephs, Debra Chowdhury, Simon Rudman, Sarah Hughes, Simon Relton, Clare Van Hemelrijck, Mieke BMJ Open Oncology 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. BMJ Publishing Group 2019-09-26 /pmc/articles/PMC6773355/ /pubmed/31558452 http://dx.doi.org/10.1136/bmjopen-2019-029468 Text en © 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. 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/. |
spellingShingle | Oncology Wylie, Harriet Cahill, Fidelma Santaolalla, Aida Moss, Charlotte Louise Enting, Deborah Amery, Suzanne Chatterton, Kathryn Khan, Muhammad Shamim Bryan, Richard T Gillett, Cheryl Josephs, Debra Chowdhury, Simon Rudman, Sarah Hughes, Simon Relton, Clare Van Hemelrijck, Mieke Graham Roberts Study protocol: first ‘trials within cohort study’ for bladder cancer |
title | Graham Roberts Study protocol: first ‘trials within cohort study’ for bladder cancer |
title_full | Graham Roberts Study protocol: first ‘trials within cohort study’ for bladder cancer |
title_fullStr | Graham Roberts Study protocol: first ‘trials within cohort study’ for bladder cancer |
title_full_unstemmed | Graham Roberts Study protocol: first ‘trials within cohort study’ for bladder cancer |
title_short | Graham Roberts Study protocol: first ‘trials within cohort study’ for bladder cancer |
title_sort | graham roberts study protocol: first ‘trials within cohort study’ for bladder cancer |
topic | Oncology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6773355/ https://www.ncbi.nlm.nih.gov/pubmed/31558452 http://dx.doi.org/10.1136/bmjopen-2019-029468 |
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