FAQs

A Phase I study is designed to find out:

• what is the most effective dose of the drug and how much can be given safely. For example, the maximum acceptable dose and how often the drug can be given
• whether enough of the drug is circulating in the blood to affect cancer cells
• the possible side effects of the drug.

There are two problems with this type of study. Firstly, patients treated at the lowest dose may not benefit significantly from the new drug. Secondly, patients treated later at, or near, the maximum dose may have more side effects. Doctors try to raise the dose as quickly and safely as possible while avoiding any unnecessary side effects.

If it is thought that the new drug may be active against particular cancers, patients with those cancers will be selected for the trial. However, finding out which cancers respond best to the drug is the main aim of a Phase II study.

Source: Royal Marsden Hopsital website: https://www.royalmarsden.nhs.uk/about-royal-marsden/our-research/clinical-trials/what-types-clinical-trial-are-there

A Question Prompt List is a tool to improve discussions of cancer care by doctors and patients. It includes a list of standard questions to help involve a patient in decision-making also provides a framework for patients to ask about their disease.

In this project the QPL will be given to patients considering a phase I trial, after they have used the QPL in their informed consent consultation they will be interviewed in order to gain an understanding of their experience. 

The Oncologists that take a written consent from the patient will also be interviewed to gain their perspective on the use of a QPL. The transcribed data will be analysed in order to create ideas for possible future development and use of the QPL in this context.

Ideally it would be good to have a target audience of patients who have received systemic anti- cancer therapy.

Although this therapy would not have to be part of a clinical trial that experience would also be useful.