Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A study using mobile phones to report side effects of chemotherapy (eSMART)
This study is open to people having chemotherapy for breast cancer, bowel (colorectal) cancer, non Hodgkin lymphoma and Hodgkin lymphoma.
More about this trial
You can often manage side effects at home without advice from the healthcare team such as a doctor or nurse. But there might be times you can’t and need some advice from the healthcare team.
In this study researchers are looking at using a mobile phone to report side effects of chemotherapy. You answer a short questionnaire on the mobile phone and record your temperature. This information is analysed and if necessary a member of the healthcare team will phone you back.
The researchers want to compare using the mobile phone with the standard way of managing side effects to find if it is better or worse.
Who can enter
The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
You may be able to join this study if you have one of the following
And all of the following apply
- You are about to start having chemotherapy
- Your treatment cycle for chemotherapy is every 2 weeks, 3 weeks or 4 weeks
- You are having at least 3 cycles of chemotherapy treatment
- You are at least 18 years old
You cannot join this study if any of these apply
- Your cancer or lymphoma has spread to another part of the body
- Your cancer or lymphoma has come back after previous treatment (relapsed)
- You are having radiotherapy with chemotherapy (
- You are having chemotherapy every week
- You have had chemotherapy in the past 5 years
- You have had another cancer in the past 5 years
- You have any other medical or mental health condition that the team think could affect you taking part
The study team need 1,108 people to join.
This is a randomised study. You are put into 1 of 2 groups by a computer. Neither you nor your doctor can choose which group you are in.
- People using the mobile phone to manage their side effects
- People managing their side effects in the usual way
Mobile phone users
You have a mobile phone and a thermometer to take your temperature. A member of the team will show you how to use both the phone and the thermometer. You also have a booklet with instructions about how to use the phone and numbers to contact for help.
During your chemotherapy you fill in a short questionnaire on the mobile phone. You do this once a day and anytime you feel unwell. The questionnaire will ask if you are at home or in hospital and about your side effects. You also take your temperature and record it on the phone. This should take no longer than 5 minutes.
Your information is sent to a computer. It analyses the information. An alert is sent to the hospital if your side effects are moderate or severe. Then the following actions take place.
A doctor or nurse will phone you:
- for moderate side effects they’ll do this within 4 to 8 hours if they feel that your symptoms need further attention
- for severe side effects it will be within 30 minutes
They will ask you about your side effects and give advice as appropriate.
They will phone on your home number (landline) or your own mobile number.
For people who say they are ‘in hospital’ your information is collected by the computer. But no alert is sent.
On the mobile phone you are also able to get information about how to manage some side effects.
People not using the mobile phone
Your doctor or nurse will talk to you about managing your side effects and what to do if you need to contact someone for advice.
When you start chemotherapy and before the start of each treatment cycle you fill in a few questionnaires. This takes about 40 to 60 minutes. The questions are about:
quality of life
- your confidence in doing tasks
- any health needs
- any anxiety
- any work issues
- using health care services such as seeing your GP
You complete the same questionnaires:
- a week after finishing chemotherapy
- then at 3, 6, 9 and 12 months
You might be asked about your side effects halfway through your chemotherapy treatment cycles. A member of the study team will phone you and ask a few questions. They won’t be giving any advice on how to manage your side effects during the call.
There are no extra hospital visits expected if you take part.
You might be asked to come into hospital after talking to the doctor or nurse on the phone if they think this is best for your health and safety.
There are no side effects if you take part.
How to join a clinical trial
Professor Roma Maguire
European Commission’s FP7 health programme
NIHR Clinical Research Network: Cancer
University of Strathclyde