Quality of life in Clinical Trials

Fast facts

• Official title: Patient reported core outcomes in brain tumour trials: The COBra study
• Lead researcher: Professor Anthony Byrne
• Where: Cardiff University, Wales
• When: January 2021 – September2022
• Cost: £152,949 over 20 months
• Research type: Adult, High and Low Grade, Quality of Life, Clinical
• Award type: Quality of Life

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Clinical trials for brain tumours traditionally focus on how a tumour responds to a new treatment, and how long the participant survives both the tumour and the treatment. Now there’s growing recognition that studies need to better consider wider-ranging outcomes such as quality of life (QoL) and a person’s ability to live well after their treatment.

This is particularly relevant where survival benefits from new treatments are only modest. Even modest survival benefits may be more powerful if viewed alongside improved quality of life, and this allows more informed choices about care.

Patient Reported Outcomes (PROs) record a person’s experience of their disease and its treatment e.g. QoL information. Use of PROs allows assessment of the balance between tumour responses and effects on patients.

In the current landscape, challenges arise because many brain tumour trials gather PROs but don’t assess them alongside tumour response, or sometimes don’t report on them at all. Another stumbling block arises when different trials assess different PROs, making it difficult or impossible to compare or combine different studies.

What is it?

To remedy this, Professor Byrne and his team will combine the experiences of people with a glioma (grades II-IV), their families and findings from other neuro-ongology researchers. They will define a Core Outcome Set (COS) that includes the aspects of quality of life most important to them all, and promote its use in UK glioma clinical trials. COS development in other disease areas conditions has improved the quality and consistency of information captured, facilitating data sharing to produce practice-changing results.

Initially a core group of stakeholders, including people with a brain tumour, family representatives, clinicians and researchers, will meet to review and agree the scope of the study e.g. which types of tumours will be included.

Next the researchers will go through all the published data to find which types of PROS have been measured previously.

Together these measures will be grouped under general categories i.e. wellbeing or relationships. These groups will then be presented back to the stakeholder groups to ensure they have captured all appropriate PROs.

With this long list of outcomes, the team will then undertake a ‘Delphi process’. This uses two rounds of online surveys to ask a larger stakeholder group to consider all the outcomes listed and rank them according to importance. At the end of the process a smaller number of core outcomes will have been defined.

The last step in this project will be to have a stakeholder consensus meeting to share the results of the Delphi process and agree a final COS.

The COS will drive standards on inclusion, analysis and reporting of patient and family outcomes. This will ensure trial results reflect impact of treatment on overall quality of life, helping brain cancer patients and their families make informed choices regarding their care.

Professor Anthony Byrne

Why is it important?

This project will produce a high quality, consistent approach to measuring patient and family outcomes in glioma studies. It’ll ensure that future trial results reflect impacts of treatment on lived experience and quality of life, helping brain cancer patients and their families make informed choices about their care.

Who will it help?

In the short-term this project will help the people with a brain tumour who contribute to the research. It’ll reassure them that their opinions and needs are being heard and will empower them to have a positive impact on the future of quality of life research.

In the longer term having a consistent approach to PROs in glioma clinical trials will mean that quality of life will be a higher priority when assessing potential new treatments. This will mean that people undergoing treatment for a glioma in the future will have better prospects, not just in terms of how long they live, but also how well.

Milestones

The researchers have collected a large amount of information from different sources. They have also identified additional issues that are important to the participants of their research, which will be recorded and considered once the study is complete.

“The response of patients, and those close to them, to our call for participants for the interviews has been extremely encouraging to us as a team, as it has further emphasized how important patients feel this work is. We had many more offers of help than could be accommodated within the interview process and those respondents have offered to continue to support the study in other ways including during the Delphi surveys.”

Professor Anthony Byrne

Next Steps

The team are now focused on the completion of Stage IV and V.

Stage IV: Outcomes will be transferred onto the framework for presentation to the Expert Group

Stage V: Undertaking the “Delphi Process”, which uses two rounds of online surveys to ask a larger stakeholder group to consider all the outcomes listed and rank them according to importance.

This ranking along with the final consensus meeting will enable the completion of the COS development.