A study looking at developing a quality of life questionnaire for people having adoptive cell therapy (iMATCH)
Cancer type:
Status:
Phase:
This study is looking at developing a 
questionnaire for people who are having an .
More about this trial
Adoptive cell therapy is also called Advanced Therapy Medicine Products (ATMP). ATMPs are a type of . It uses your own to recognise and kill cancer cells. An example is CAR T-cell therapy.
You may be asked to fill in quality of life questionnaires if you have cancer or if you take part in a . You may hear these questionnaires called patient reported outcome measures, or PROMs for short. Doctors use PROMs to assess how you have been feeling and to rate your quality of life. They are an important way to find out about your experiences during and after treatment.
Questionnaires are sometimes designed for use with particular treatments. Adoptive cell therapy is still a quite new treatment. There isn’t a questionnaire particularly for this treatment.
In this study, the researchers are developing an ATMP-PROM. There are 4 stages to the study. In stage 1 and 2, they asked people about the therapy and how it affected them. They then developed a version of the ATMP-PROM questionnaire.
This is the third stage of the study. In this stage they want you to fill in an early version of the questionnaire. This is to see how it measures quality of life. They will use this information to develop the final questionnaire in stage 4.
The overall aim of this study is to develop an ATMP-PROM questionnaire.
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
You may be able to join this study if all of the following apply. You:
- are due to have or are having adoptive cell therapy. This could be as part of a clinical trial or as a standard treatment such as CAR T-cell.
- can understand and speak English
- are at least 16 years old
Trial design
The team need 100 people to take part. You fill in 3 questionnaires.
The first is an early version the ATMP-PROM questionnaire. The questions ask you about:
- your symptoms
- your mental health
- how the treatment and symptoms have affected your quality of life
This will take about 10 minutes.
The second is a questionnaire that doctors use to find out:
- about your general wellbeing
- what daily activities you can do
The third questionnaire asks you about yourself and your diagnosis. For example, it will ask your age, gender, cultural background (ethnicity) and the cancer type you have.
The team will ask 50 people to fill in only the ATMP-PROM questionnaire a week later. This is to see whether your responses have changed. The team will post this questionnaire to you. They provide a pre paid addressed envelope to return it.
Where possible, the team will ask you to complete the questionnaires at one of your routine appointments.
Hospital visits
There are no extra hospital visits for this study.
Your personal details and your responses will be stored securely and only the team can access these. Your responses will be anonymised so these can’t be linked back to you.
Side effects
The team do not intend for the questions to be upsetting. But you might feel uncomfortable thinking or talking about your illness and your experience of treatment and care.
If you do feel uncomfortable the team can give you support. They can give you the contact details of other professionals who can give you support.
You do not have to answer all of the questions and you can stop taking part at any time.
Location
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.
Chief Investigator
Professor Fiona Thistlewaite
Supported by
The Christie NHS Foundation Trust
NIHR Manchester Biomedical Research Centre
Experimental Cancer Medicine Centres (ECMC)
GlaxoSmithKline
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
