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)

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.

Keywords: clinical trials; medical ethics; oncology.

Conflict of interest statement

Competing interests: This study has not received a specific grant and is not externally funded and has not undergone peer review by the funding body. The authors declare the following competing interests, none of which are directly related to this study. AP, DM, BRB, RD, JL-K, SS: none declared; CY has received fees from Celgene and Faron unrelated to this work, is an associate editor for Trials; AM has served on advisory boards and received fees from Merck, Faron, Novartis, Bayer and Janssen, all unrelated to this work; UB has received honoraria from Astellas, Novartis, Karus Therapuetics, Pheonix Solutions, Eli Lilly, Astex, Vernalis, Boehringer Ingelheim, is a recipient of a National Institute for Health Research (NIHR) Research Professorship Award and has received CRUK funding: Cancer Research UK Scientific Executive Board, Cancer Research UK Centre Award, Cancer Research UK Drug Discovery Committee—Programme Award, all unrelated to this work; JDB has served on advisory boards and received fees from many companies including AstraZeneca, Astellas, Bayer, Bioxcel Therapeutics, Boehringer Ingelheim, Cellcentric, Daiichi, Eisai, Genentech/Roche, Genmab, GSK, Janssen, Merck Serono, Merck Sharp & Dohme, Menarini/Silicon Biosystems, Orion, Pfizer, Qiagen, Sanofi Aventis, Sierra Oncology, Taiho and Vertex Pharmaceuticals. He is an employee of The ICR, which have received funding or other support for his research work from AZ, Astellas, Bayer, Cellcentric, Daiichi, Genentech, Genmab, GSK, Janssen, Merck Serono, MSD, Menarini/Silicon Biosystems, Orion, Sanofi Aventis, Sierra Oncology, Taiho, Pfizer, Vertex, and which has a commercial interest in abiraterone, PARP inhibition in DNA repair defective cancers and PI3K/AKT pathway inhibitors (no personal income). He was named as an inventor, with no financial interest, for patent 8822438. He has been the chief investigator (CI)/principal investigator (PI) of many industry sponsored clinical trials. JDB is an NIHR Senior Investigator. All unrelated to this work; DK: none declared; FB received fees for Advisory Boards for Roche, Novartis, Eisai, Pfizer and Eli Lilly. She has been the site PI/CI for many industry sponsored clinical trials, all unrelated to this work. Friends of the Mater Foundation support her academic appointment at the University of Sydney and her supervision of this work. JL: research grant funding from Roche, Basilea and Genmab, all unrelated to this work.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

Schema of study design of CONSENT. *Primary endpoint is being undertaken. †Questionnaire will be delivered and received via encrypted email, or paper version. IIT, investigator-initiated trial; PIS, participant information sheets; QuIC (A/B), Quality of Informed Consent Questionnaire Parts A and B.