A study to find out if a new device can improve the management of people with borderline sepsis (ADVANCE)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

All cancer types

Status:

Closed

Phase:

Other

This study is looking at a new piece of equipment. It aims to find out if using it can improve the care of people with suspected neutropenic sepsis. This sepsis is due to their cancer treatment.

It is open to people who are having treatment at Velindre Cancer Centre and are:

in hospital because they might have neutropenic sepsis

need another blood test before their next treatment because their white blood cell count is low

More about this trial

Having chemotherapy or radiotherapy affects how well your bone marrow Open a glossary item makes:

red blood cells
white blood cells
platelets

During treatment doctors check the levels of your blood cells. You have these tests before you can have your next treatment. This is to make sure they have recovered enough for you to have the treatment.

White blood cells are the cells that protect the body from infection. Having low levels of white blood cells can make you more likely to get an infection. Of interest to the doctor is the neutrophil Open a glossary item . This is an important white blood cell for helping fight infection.

Sepsis Open a glossary item is a serious infection that affects the whole body and can be life threatening. Neutropenic sepsis is a type of infection that can happen when you have a low number of neutrophils.

You need to start treatment as soon as possible if you have any signs of infection and your doctor thinks you might have neutropenic sepsis. This means you might need to start antibiotics before they know for sure that you have neutropenic sepsis. You have these through a through a drip in a vein (intravenous infusion Open a glossary item ). You will need to be an inpatient.

To find out if you have sepsis you have blood tests. This is to see if your neutrophils are low and if you have an infection. The sooner the doctor knows if your neutrophils are low the better.

In this study researchers are using a device called the OLO system. The regulatory authority that approves medical devices in the UK has approved the system.

The OLO system uses a small drop of blood to measure the number of neutrophils in the blood. It only takes 11 minutes to do so. It is much easier and quicker than doing a blood test.

The researchers think that people having cancer treatment might eventually be able to use the system at home or at the GP surgery to check their neutrophils levels. To find out the researchers need to test it in a trial with a large number of people.

Before doing the trial they need to know if the OLO system is as good as the system usually used for the blood test. And if enough people would join a bigger trial. This is a feasibility study.

The aims of doing this feasibility study Open a glossary item are to find out:

whether the OLO system can help to manage people who might have neutropenic sepsis due to their treatment
whether the researchers can do a bigger trial
how safe of the system is
how acceptable the system is to patients and staff

There are 3 groups in this study. Group 1 and group 2 are now completed.

There are 2 parts in group 3. The 1st part is now completed. Only the 2nd part is open.

Who can enter

The following bullet points are a summary of 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.

Who can take part
There are 3 groups in this study. Group 1 and group 2 are completed. Only group 3 is open to join.

You may be able to join group 3 if you:

are having or had chemotherapy or radiotherapy at the Velindre Cancer Centre
are at least 18 years old

Who can’t take part

You cannot join this study if one or more of the following apply. You:

have leukaemia
are not able to give informed consent

Trial design

There are 3 groups in this study.

The study team needed 72 people to join:

48 people in group 1 - completed
24 people in group 2 - completed

Group 3
In group 3 there are 2 parts. In the 1st part the team asked people to join a discussion group about the OLO system. This part of group 3 is now completed.

In the 2nd part the team are asking people to fill in a survey. The study team will ask up to 24 people to take part in the survey.

Survey
The team is inviting people to fill in a survey. The questions ask about whether you prefer to have a blood sample taken from the finger or the vein.

They will ask you to do this while you are at the hospital. It shouldn’t take more than 30 minutes to do.

They do not ask for any personal information. All answers are anonymous and confidential Open a glossary item .

After completing the survey you hand it back to the staff before you leave the hospital. By doing so you give your consent Open a glossary item for your answers to be included as part of the survey.

You don’t have to do the survey if you don’t want to.

Group 1 - completed
You are in hospital because your doctor thinks you might have neutropenic sepsis. You have had blood tests and are waiting for the results. You may have started having antibiotics.

Taking part in the study won’t change any treatment you have started or may start.

Your nurse or doctor will talk to you about the study. They will leave you an information sheet about it to read. Up to an hour later they will ask if you’d like to take part. If you agree to taking part, you sign a consent form Open a glossary item .

For the study the nurse uses a small needle to prick your fingertip. They take a small drop of blood and put it into the OLO device. The OLO device shows how many white blood cells there are. You won’t know what the results of the OLO test are.

When you leave hospital you take home a card which is a questionnaire and diary. You fill it in everyday or once a week. You record:

your experience of the OLO device
any treatment such as antibiotics you’re having for your suspected neutropenic sepsis
what other healthcare services such as your GP that you have used during your suspected neutropenic sepsis

You bring the questionnaire and diary card back with you when you attend follow up for your:

suspected neutropenic sepsis or
routine cancer clinic

This is usually about 3 to 4 weeks later.

Group 2 - completed
You have had your blood test before your next treatment is due. The results show your white cell count is borderline as to whether you should have treatment. This means that you need to have the same blood test done again to check the white blood cell count is good enough to go ahead. You might have the blood test again a couple days before or on the day of treatment.

When you come in for the blood test a nurse or doctor will talk to you about the study. They’ll give you an information sheet about it to read. You have an hour to read it. After this the nurse or doctor will see if you have any questions and if you would like to take part. If you agree to you sign a consent form.

For the study the nurse uses a small needle to prick your fingertip or take it from a vein in the arm using a needle. They take a small drop of blood and put into the OLO device. The OLO device shows how many white blood cells there are. You won’t know what the results of the OLO device are.

Taking part in the study won’t change any treatment you might have for suspected neutropenic sepsis. Neither will it change your cancer treatment.

Group 3 (discussion group) - completed
The team might ask you or your carer or both of you to take part in a discussion group. The discussion will include topics such as:

views about the current management of suspected neutropenic sepsis
confidence in using the OLO system instead of the standard tests
benefits and disadvantages of the OLO system

The team are also inviting healthcare professionals to a separate discussion group. This includes doctors and nurses. They want to find out their views on using the OLO system.