A study looking at a service to assess side effects of radiotherapy for prostate cancer (EAGLE)
Cancer type:
Status:
Phase:
This study looked at developing a service to assess and help men who have long term side effects caused by radiotherapy for prostate cancer.
It was open for people to join between 2015 and 2017, and the team finalised the results in 2019.
More about this trial
Doctors often use radiotherapy to treat prostate cancer. Like all treatments, it can cause side effects, such as bowel problems.
Sometimes people have bowel related side effects during treatment, and sometimes after treatment finishes. Long term side effects can cause significant problems with people’s quality of life, affecting their social life, work or travel plans.
Researchers wanted to develop and test a new service to improve the wellbeing of men who have long term side effects from radiotherapy for prostate cancer.
The main aim of this study was to introduce a service that could improve the lives of men with bowel problems after radiotherapy. It was for men who had radiotherapy aimed at curing their prostate cancer. This is called radical radiotherapy.
Summary of results
The research team found that it was useful to give more support and information to men having long term side effects from radiotherapy.
Study design
First of all, the research team looked at the services and support already available.
Next, they asked people if they would like to take part in the study. They used 2 questionnaires to assess people’s side effects, to check they were eligible to join the study:
- Assessment of Late Effects of Radiotherapy – bowel (ALERT-B)
- Gastrointestinal Symptom Rating Scale (GSRS)
The research team saw the people taking part and asked them to complete quality of life questionnaires:
- when they joined the study
- at 6 months
- at 12 months
The team also assessed how much it would cost to provide the extra service.
The men who were eligible were referred to a specialist service for people with problems affecting their digestive tract (gastroenterological service). These services were available in 3 NHS centres. Two were led by a clinical nurse specialist (CNS). One was led by a specialist doctor, a consultant gastroenterologist.
The men were given extra support, information and advice on ways to manage or help their side effects.
The research team also held interviews with a total of 51 people, to find out what people thought about the new specialist service. This included patients, relatives and health care professionals (including specialist doctors and nurses). They were interviewed at start of the study, then at 6 months and 12 months.
Results
The research team assessed the side effects of 339 men using the ALERT-B and GSRS tools. They found that 91 men (27%) had side effects which meant they were eligible to take part in the study.
58 of the 91 men agreed to be referred to the specialist team for help with their side effects. Of these:
- 36 went to the 6 month appointment
- 23 went to the 12 month appointment
The results showed that people’s bowel symptoms improved. The cost analyses also found that there may be some benefit for this new service led by a specialist nurse. But the analysis included a relatively small number of people, so it’s difficult to draw firm conclusions.
The research team analysed what people thought about the study in the interviews, focusing on 4 main themes:
- Barriers and facilitators. People were willing to join both the study and the service, and felt that the service would be a benefit. Some people felt there were a lot of questions to answer, but did not say if this was because of the service or the questionnaires for the study.
- Capacity. There were some concerns about cost and staffing after the research funding ended. But people hoped the service would continue.
- Expertise. Patients and health care professionals recognised the skills of the specialist nurses. They were happy to see either a nurse or a doctor. The different health care professionals worked well together, attending meetings and keeping each other up to date.
- Making a difference. Patients found the information they were given about their symptoms useful. They felt they had more support than they had before. Some people had felt they should accept the side effects, as treating their cancer was the most important thing. But the new information and support had helped with their side effects. The health care professionals felt this could benefit people having radiotherapy for other cancers too.
Conclusion
The research team concluded that the extra support and information helped men who were having long term side effects from prostate radiotherapy.
The ALERT-B tool and a nurse led service could also help patients with other types of cancer in the pelvic region.
They suggest further research is done with more people and for longer, to help find out more about the cost and the effect on quality of life.
Where this information comes from
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists () and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr Annemarie Nelson
Dr John Staffurth
Supported by
Cardiff University
Macmillan
Marie Curie
Marie Curie Palliative Care Research Centre (MCPCRC)
NIHR Clinical Research Network: Cancer
Prostate Cancer UK
Tenovus Innovation Grant
TrueNTH UK
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040