Improving Informed Consent for Early Phase Anti-Cancer Trials
Research type
Research Study
Full title
A Randomised Controlled Trial of Enhanced Informed Consent Compared to Standard Informed Consent To Improve Patient Understanding of Early Phase Oncology Clinical Trials
IRAS ID
277065
Contact name
Juanita Lopez
Contact email
Sponsor organisation
Royal Marsden Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 16 days
Research summary
Cancer is the leading cause of death in developed countries and there is an urgent need to develop more effective treatments with fewer side effects across the majority of cancers. Early phase clinical trials are mandatory for new promising anti-cancer drugs discovered in the laboratory - doctors need to work out the safe dose to use and whether the side effects are tolerable or not. These early phase clinical trials are carried out in patients who have an advanced cancer (one that has spread to more than one part of the body) and do not have any standard therapeutic options available to them. The research in this area has shown that patients placed in these situations where they are considering participating in early phase clinical trials, often have difficulty in understanding the rationale and design of these trials - this in turn has raised questions about the ethics of performing early phase clinical trials in this vulnerable population. In addition, early phase clinical trials are becoming increasingly complex and the participant information brochures are reaching lengths of up to 60 pages which make it incredibly difficult for participants to understand these trials. We would like to improve this process and help patients better understand these trials - we have professionally produced a series of 10 jargon free videos that range from 1 - 2 minutes and we have also produced, with the help of patients, a 2 page study aid template to help patients understand trials. We would like to test the effectiveness of the combined strategy in a randomised controlled trial setting.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
20/EE/0155
Date of REC Opinion
15 Jun 2020
REC opinion
Favourable Opinion