A study looking at online reporting of side effects at home after cancer treatment (ePRIME)

Cancer type:

Ovarian cancer

Status:

Open

Phase:

Other

This study is for women with ovarian cancer, including fallopian tube cancer and primary peritoneal cancer, who have finished treatment. And who are going to one of the following hospitals:

  • St James’ University Hospital Bexley wing
  • Bradford Teaching Hospitals NHS Foundation Trust
  • Calderdale & Huddersfield NHS Foundation Trust
  • Airedale NHS Foundation Trust

More about this trial

There is a ‘Before’ and ‘After’ part to this study. 

ePRIME is a web based system for patients to report symptoms while they are at home. The researchers want to find out how well it works compared with the standard care patients get when they are going to the hospital frequently. 

This study is for women after they have had treatment for ovarian cancer.

The Before part

Before the ePRIME system is tested, the researchers need to know about the symptoms and experiences of patients who have the usual follow up care after treatment. 

This means that the team will ask women who have completed treatment for ovarian cancer to fill in a questionnaire. The answers will tell them about:

  • how the services currently run
  • the relationship between patient and doctors, and or nurses
  • the patients’ experiences 
  • patients’ quality of life Open a glossary item during follow up

The After part

This part is currently only open in St James’ University Hospital, Leeds.

Patients will use the ePRIME system after treatment to record their symptoms.

The researchers will compare the responses of the women in the After Study with those in the Before Study.

The aims are to find out:

  • how well the ePRIME system works
  • about the patients’ experiences

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor running the study 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 are a woman who is going to one of the following hospitals:

  • St James’ University Hospital Bexley Wing 
  • Bradford Teaching Hospitals NHS Foundation Trust 
  • Calderdale and Huddersfield NHS Foundation Trust
  • Airedale NHS Foundation Trust

You have one of the following cancers:

And all of the following must appy:

  • Your cancer was stage 1c to 4
  • You have finished treatment 
  • There is no sign of cancer on examination or tests (it is in remission) or they show the cancer has reduced (a partial remission)
  • You are able to read and understand English
  • You have access to the internet
  • You are at least 16 years old

You cannot join this study if you have a mental health condition or problems with your mental capacity such as a learning disability.

Trial design

There are 2 parts to this study. 

Part 1 (Before Study)
This part of the study looks at what is the usual care for women who have had treatment for a gynaecological cancer. The team need 60 women to join this stage. 

You fill in a questionnaire when you join the study then at:

  • 6 months
  • 12 months

The questions ask about your general health, how you are feeling and any side effects you might have. 

At the end of these 12 months, the team might ask you to take part in an interview about your experience of follow up after treatment. 

Part 2 (After Study)

In this part the women will use the ePRIME system. The team need 60 women to take part in this stage.

Instead of going to the hospital for a follow up appointment every 3 months, you:

  • have your bloods taken at your GP or local hospital
  • complete the ePRIME online symptoms questionnaire

ePRIME system

The team will explain the ePRIME system to you. And what you need to do.

You are given unique log-in details to access the ePRIME online symptom questionnaire. You can complete the questionnaire on a:

  • computer
  • laptop
  • smart phone
  • tablet

You are emailed or texted every 3 months to remind you to get your blood test done and complete the questionnaire.

You can fill in the questionnaire at other times too when you:

  • feel unwell
  • have new symptoms

The questionnaire takes about 15 minutes to complete.

Bloods

You have your routine bloods done at your GP’s or the local hospital. The team will give you all the necessary forms and will explain this to you.

The hospital team looking after you will see your responses and blood results. They will phone you or arrange a clinic appointment, if necessary.

You can contact your hospital team at any time for advice or to arrange a clinic appointment.

You are in the study for a year while you are being followed up and not having treatment.

After the year you continue your follow up with the doctor at the hospital. You have an appointment with them and they will tell how often they want to see you.

Paper questionnaires

You fill in a paper questionnaire half way through the study (6 months) and at the end (12 months). This will take about 30 minutes to complete. The questions will ask you:

  • about your quality of life  Open a glossary item
  • about your general health
  • how many times you have contacted the hospital team for example phone calls to the nurse specialist
  • about other health services you have used for example GP appointments

These are posted to your home address with a stamped addressed envelope to return them.

Interview

At the end of the study you will be asked to give feedback on the study and ePRIME system. A member of the research team will interview you. 

You don’t have to agree to do this. 

Hospital visits

Any interview will be arranged at a time and place convenient to you. 

Side effects

There are no side effects if you take part in this study.

Location

Airedale
Bradford
Calderdale
Leeds

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

Professor Galina Velikova

Supported by

Leeds Teaching Hospitals NHS Trust 
Yorkshire Cancer Research
University of Leeds

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14613

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

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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