Cognitive function study Version 0.3
Research type
Research Study
Full title
The Impact of targeted therapies given within Phase I trials on the cognitive function of patients.
IRAS ID
235668
Contact name
Theresa Wiseman
Contact email
Sponsor organisation
Royal Marsden NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This is a PhD project, it is a mixed methods study concerning the cognitive function of patients with cancer on Phase I trials. It's suspected that some of the novel targeted therapies tested within Oncology first in man trials may have a negative impact on cognitive function of patients with cancer. This is a known side effect of traditional cytotoxic anti-cancer drugs but has not been investigated as a consequence of novel targeted therapies. The study aims to define and characterize this potential consequence of treatment. Cognitive function will be measured first objectively by using validated cognitive assessment tools and secondly using a qualitative interview to investigate what such a side effect of treatment means to the patient in terms of any impact on their lives. It is important to find out if and how this is happening so that patients can be better informed about some of the potential effects of the trial treatments and supported with coping strategies to help manage the problem. The study will be conducted in a Phase I clinical trials unit in a specialist cancer hospital and most patients who are participating in the trial will be eligible to participate if they wish. These are patients with a variety of advanced solid cancers. For this study the patients entering a Phase I clinical trial will have a pre-treatment assessment of cognitive function using the validated tools and 3 patient reported outcome questionnaires. This will take approximately one hour and forty minutes. These assessments will be repeated at day 8 and day 28 post treatment start date. The patient will also have a semi-structured interview to last up to one hour at day 28. The data will be integrated to provide a description the potential problem and any suggested management strategies in this patient group.
REC name
London - Queen Square Research Ethics Committee
REC reference
18/LO/0084
Date of REC Opinion
1 Feb 2018
REC opinion
Favourable Opinion