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Study protocol for a randomised controlled trial of enhanced informed consent compared to standard informed consent to improve patient understanding of early phase oncology clinical trials (CONSENT).
Pal, Abhijit; Stapleton, Sarah; Yap, Christina; Lai-Kwon, Julia; Daly, Robert; Magkos, Dimitrios; Baikady, Bindumalini Rao; Minchom, Anna; Banerji, Udai; De Bono, Johann; Karikios, Deme; Boyle, Frances; Lopez, Juanita.
  • Pal A; Institute of Cancer Research, London, UK abhijit.pal@sydney.edu.au.
  • Stapleton S; Drug Development Unit, Royal Marsden Hospital Sutton, London, UK.
  • Yap C; The University of Sydney, Sydney, New South Wales, Australia.
  • Lai-Kwon J; Drug Development Unit, Royal Marsden Hospital Sutton, London, UK.
  • Daly R; Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.
  • Magkos D; Clinical Trials and Statistics Unit, Institute of Cancer Research, London, UK.
  • Baikady BR; Institute of Cancer Research, London, UK.
  • Minchom A; Drug Development Unit, Royal Marsden Hospital Sutton, London, UK.
  • Banerji U; Institute of Cancer Research, London, UK.
  • De Bono J; Drug Development Unit, Royal Marsden Hospital Sutton, London, UK.
  • Karikios D; Institute of Cancer Research, London, UK.
  • Boyle F; Drug Development Unit, Royal Marsden Hospital Sutton, London, UK.
  • Lopez J; Institute of Cancer Research, London, UK.
BMJ Open ; 11(9): e049217, 2021 09 06.
Article in English | MEDLINE | ID: covidwho-1408526
ABSTRACT

INTRODUCTION:

Early phase cancer clinical trials have become increasingly complicated in terms of patient selection and trial procedures-this is reflected in the increasing length of participant information sheets (PIS). Informed consent for early phase clinical trials has been contentious due to the potential ethical issues associated with performing experimental research on a terminally ill population which has exhausted standard treatment options. Empirical studies have demonstrated significant gaps in patient understanding regarding the nature and intent of these trials. This study aims to test whether enhanced informed consent for patient education can improve patient scores on a validated questionnaire testing clinical trial comprehension. METHODS AND

ANALYSIS:

This is a randomised controlled trial that will allocate patients who are eligible to participate in one of four investigator-initiated clinical trials at the Royal Marsden Drug Development Unit to either a standard arm or an experimental arm, stratified by age and educational level. The standard arm will involve the full length trial PIS, followed by electronic or paper administration of the Quality of Informed Consent Questionnaire Parts A and B (QuIC-A and QuIC-B). The experimental arm will involve the full length trial PIS, exposure to a two-page study aid and 10 online educational videos, followed by administration of the QuIC-A and QuIC-B. The primary endpoint will be the difference (using a one-sided two-sample t-test) in the QuIC-A score, which measures objective understanding, between the standard and experimental arm. Accrual target is at least 17 patients per arm to detect an 8 point difference (80% power, alpha 0.05). ETHICS AND DISSEMINATION Ethics approval was granted by the National Health Service Health Research Authority on 15 June 2020-IRAS Project ID 277065, Protocol Number CCR5165, REC Reference 20/EE/0155. Results will be disseminated via publication in a relevant journal. TRIAL REGISTRATION NUMBER NCT04407676; Pre-results.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / Neoplasms Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: BMJ Open Year: 2021 Document Type: Article Affiliation country: Bmjopen-2021-049217

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / Neoplasms Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: BMJ Open Year: 2021 Document Type: Article Affiliation country: Bmjopen-2021-049217