The CARE Trial
Short Participant Information Sheet
COULD SUPPORTED WEIGHT LOSS REDUCE BOWEL CANCER SURGERY COMPLICATIONS?
What is the purpose of this research?
- Physical fitness and well-controlled blood sugar are linked with fewer complications after surgery.
- For people carrying excess weight, losing weight improves both of the above, so it could reduce complications after surgery.
- This research will try to find out how practical it is to lose weight after a bowel cancer diagnosis and while waiting for surgery.
- This will help us to see, in future research, whether losing weight is of benefit to a larger number of patients.
Why have I been invited?
- Because you may need surgery for cancer in your bowel.
If you do not have surgery, this research will not be suitable for you.
- You may read the information now and decide about taking part later.
What will I have to do?
You will need to agree to be put at random into 1 of the 2 groups:
A. Normal care group
B. Supported weight loss group
|You will carry on with your normal care as usual - nothing about your care will change.||You will eat only nutritious shakes and soups until two days before your surgery. A specialist will support you over the phone.|
- You will also need to
✅ come to the hospital twice for 1-2 hours: one time before you start the research and one time about 30 days after your surgery. You will have some simple measurements taken, such as your weight, and fill in brief questionnaires.
✅ fill in brief questionnaires once at home.
✅ tell us about how you found the trial and the diet in one or two audio-recorded phone interviews.
What if I am in the supported weight loss group?
- Supported by a specialist, most people have been able to follow the diet.
- We chose to use this diet because, on average, people who follow it lose more weight than people following diets based on eating less of regular food.
- You will be asked to eat only nutritious soups and shakes until 2 days before your surgery. These products contain
✅ all the vitamins and minerals essential for good health
✅ plenty of protein and fibre to help you feel full
✅ far fewer calories than most people usually eat.
✅ gluten-free and free of nuts, sesame, and shellfish.
✅ suitable for Halal, Hindu, or Kosher diet
✅ already used by the NHS in other medical conditions.
- You can choose from a variety of flavours.
- We will provide you with these products for free.
- You will have weekly consultations with a specialist (a dietitian) who will support you over the phone or through video calls.
Other points to consider
- By taking part, you will help us find out if this treatment might help people with bowel cancer in the future.
- Supported weight loss: Most people do not experience side effects from the low-calorie diet. You may experience side effects, such as constipation, but most side effects are only mild and go away when you stop the diet. We will check these regularly.
- We will offer you vouchers up to £30 for your travel expenses for each of the two journeys to the hospital.
What if I want to stop taking part?
- You are free to leave the research at any point.
- All your data will be kept strictly confidential.
Our contact details
Please contact your local research team.
Telephone: 07584 388758 Email: email@example.com