A study looking at the information doctors and nurses give about phase 1 trials

Cancer type:

All cancer types

Status:

Results

Phase:

Other

This study looked at the information doctors and nurses gave people about phase 1 clinical trials and how well people understood it. This trial was supported by Cancer Research UK.

All new treatments and procedures have to be thoroughly tested before they can become part of standard treatment. Studies involving people are called clinical trials.

Before people agree to take part in a clinical trial, doctors must explain it to them in detail. But it can be difficult to explain the risks, benefits and main purpose for doing the trial. And this information can be hard for people to understand, especially if they are feeling anxious or unwell. The way that doctors explain a phase 1 trial may influence someone’s decision about whether or not to take part.

In this study, the researchers looked at how doctors talked to people about taking part in a phase 1 trial. They hoped to learn more about what people understood from these discussions. And they wanted to find out the reasons why people decided to take part in a trial or not.

Summary of results

The study team found that what doctors say about phase 1 trials and what people hear or understand about them can often be very different. And that the positive outlook of both parties may change what they talked about and how they understood the conversation.

This study recruited 17 doctors and 58 patients. Of the 58 patients the researchers were able to look at the results of 52.

The researchers taped conversations doctors and patients had about phase 1 trials. After the doctors completed a questionnaire about what they felt had they had talked about.

The researchers talked with the patients to find out what they remembered of the conversation and what they understood.

After comparing the taped conversations with the doctors’ questionnaires and what the patients reported. The researchers found the majority agreed that the subjects discussed were

Aims of the trial
Extra burden in taking part
Possible side effects
Taking part was voluntary

The outlook for the patient (prognosis Open a glossary item ) and their understanding of that was one subject doctors often did not talk about with the patient.

The researchers also asked patients to fill in a questionnaire about why they accepted or declined to take part in a phase 1 trial. The researchers have results from 40 people. The 4 main reasons people gave for going into a phase 1 trial were

Expecting to gain some medical benefit from it
The trial was the best available choice
To maintain hope
To help with research

The study team concluded that key parts of communication and information about phase 1 trials are often missing. And the patients who agree to go into phase 1 trials may be a very hopeful and positive group. All of which could make gaining proper informed consent and avoiding misleading information about the benefits of a phase 1 trial difficult.

The researchers used these results to inform an educational training package to help health care professionals discuss early phase trials with patients.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.