Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at returning to normal activities after surgery for oesophageal cancer (FARO)
Cancer type:
Oesophageal cancer
Status:
Open
Phase:
Other
This trial is looking at a rehabilitation programme after surgery for oesophageal cancer. This is to find out if it can help people return to their normal activities quicker.
It is open to people who are having their oesophageal cancer surgery at the Newcastle upon Tyne Hospitals NHS Foundation Trust.
More about this trial
Surgery is one of the main treatments for cancer of the food pipe (oesophageal cancer). This can have a major effect on your
and overall wellbeing. This affects how quick you can return to your everyday activities.
Researchers are looking at ways to help you get back to your normal activity as soon as possible after surgery. They believe that a planned programme of exercises and close dietary monitoring could help. This is a rehabilitation programme.
In this trial half the people will have the standard care as follow up after their surgery. The other half will have the standard care and take part in the rehabilitation programme.
The aim of the trial is to find out if a rehabilitation programme can help people return to their normal activities quicker after surgery.
Who can enter
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
This trial is open to people who are having their oesophageal cancer surgery at the Newcastle upon Tyne Hospitals NHS Foundation Trust.
You may be able to join this trial if all of the following apply. You:
- have had or are going to have surgery to remove cancer from the food pipe (oesophagus)
- are able to start the programme within 3 weeks of having surgery
- are at least 18 years old
Who can’t take part
You cannot join this trial if any of these apply. You:
- are not able to do the 6 minute walk test. Your doctor can tell you about this.
- have a condition such as a severe osteoarthritis of the knee or hip that affects your ability to do the daily walking or exercises as part of the programme
- have had or are going to have the lower part of your food pipe and your stomach removed. As part of this operation you will have part of your large bowel attached to the remaining part of the food pipe.
- have another cancer that needs treatment
Trial design
The trial team need 60 people to join.
It is a randomised trial. A computer puts you into 1 of 2 groups. Neither you nor your doctor chooses which group you are in. The groups are:
- standard care after surgery
- rehabilitation programme with standard care after surgery
Standard care
This is the usual follow up that everyone who have surgery to remove cancer from the food pipe. You see a dietician at 2 weeks after you leave hospital. You the surgery team at 6 weeks, 3 months and 6 months following the operation.
Rehabilitation programme
You have the standard care as above. You do the rehabilitation programme for 12 weeks.
Within 3 weeks of you leaving hospital a member of the trial team phones you to start the programme. They will talk to you about the following:
- starting daily exercise. This is walking a set number of steps every day.
- doing strength exercises 3 times a week
- recording your exercise
- recording any symptoms
- recording your mood and energy levels
You have a diary to record these in.
They phone you at the end of each week starting with the 1st week. They will talk to you about:
- your daily step count and level of activity
- your strengthening exercises and whether you are able to complete them
- any symptoms you may have
- any problems or issues with your mood or energy levels
- using the diary to record your mood and energy levels
- using the activity tracker to record your activity levels
A also phones you every 2 weeks. This is to see what your diet is like and to talk about any problems you might have.
Quality of life
You fill in quality of life questionnaires when you go to hospital for follow up after surgery. A member of the trial team sees you to do this.
They will also review your study diary with you.
Research samples
You give a blood sample when you see the team at the hospital. In total you give 4 blood samples. They use these samples to measure whether you are getting enough from your diet for your body to work well. And to see if any advice the dietitian gave you is helping.
Focus group
At the end of the trial the team will invite you to take part in a focus group. In the group you talk about:
- the programme
- taking part
- how it may or may not have helped
They will tell you about the focus group when you agree to take part in the trial.
Hospital visits
There are no extra hospital visits if you take part.
When you go to the hospital at 6 weeks, 3 months and 6 months a member of the trial team will see you for some tests.
The 1st test is a 6 minute walking test. This measures how well you can tolerate exercise.
The 2nd test is a hand grip test. This measures your muscle strength.
Side effects
The team don’t expect any side effects if you take part.
You might feel more tired if you are doing the rehabilitation programme. If so tell a member of the team as soon as possible.
Location
Newcastle upon Tyne
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.
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
Chief Investigator
Alexander Phillips
Supported by
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle Hospitals Charity
Freephone 0808 800 4040
Last review date
CRUK internal database number:
17962
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
Around 1 in 5 people take part in clinical trials
