Quality of life studies

Quality of life assessment

Quality of life assessments are a way of measuring how a disease or treatment affects someone’s wellbeing. Many trials include a quality of life assessment, especially if the trial is comparing treatments. It may be included as part of the main trial. Sometimes it is a separate quality of life study (a sub study).

It is important to find out how treatments affect people’s day to day life, rather than just focus on how well they work. People will be more likely to continue with treatment if it has fewer side effects.

Questionnaires

The research team may ask you to complete questionnaires about how the treatment affects your daily life. These may include questions about:

• side effects and symptoms such as tiredness (fatigue) or pain

• your emotional wellbeing, including anxiety, depression and mood changes

• how treatment effects your relationships, hobbies and social life

• your ability to work or continue your usual daily life

• your independence and if you can look after yourself

• the financial impact of your cancer and treatment such as extra costs or loss of income

Some questionnaires are designed to be used by anyone having treatment for cancer. They will usually ask you quite general questions about how you are feeling. Other questionnaires are designed for people having treatment for a particular type of cancer. So they may ask you more about specific symptoms or possible side effects of treatment.

Most researchers will ask you to fill out a questionnaire before you start treatment. This is called the baseline questionnaire, and means the research team can see how your quality of life changes over time. You usually complete more questionnaires during and after you finish treatment. How often and for how long will depend on the trial you are taking part in.

Sometimes they will ask you to complete questionnaires regularly for some years after you finish treatment. This could be because the research team want to learn more about long term side effects.

Assessing pain

Pain can be a problem for some people with cancer, and the research team will want to know if your pain is better or worse as you go through treatment.

Most quality of life questionnaires will ask you about any pain you may be having. But sometimes research teams want to assess pain in more detail. There are a number of ways they can do this, including asking you to:

• rate how bad your pain is on a scale from 0 to 10 (or 0 to 100)

• mark on a diagram of a person where your pain is

• keep a diary of when and where you get pain, how bad it is and what painkillers you take

• complete an extra questionnaire which asks you in more detail about your pain

Keeping a diary

The research team may also ask you to keep a diary. This could contain notes about how you feel after your treatment, or when you get a particular side effect and how long it lasts. Or you may note down how often you need to take painkillers. The specific details will be different for different trials.

Patient reported measures

You may hear the researchers use the terms PROM or PREM when talking about questionnaires in clinical trials. They are an important way to help improve treatment and healthcare.

PROM stands for patient reported outcome measures. Researchers use PROMs to assess how people are feeling, and how they rate their quality of life.

PREM stands for patient reported experience measures. Researchers use PREMs to find out what people think about the care and treatment they’re having or have had.