Dr Carrie-Anne Ng and Dr Mariana Sousa have been awarded funding by the 2024 UTS Faculty of Health Collaborative Early Career Researcher Funding Scheme.
We are thrilled to share that we have secured funding from the 2024 FOH Collaborative Early Career Researcher (ECR) Funding Scheme.
The funding is for our innovative project, “Acceptability of a modular approach in administering patient-reported outcome measures (PROMs) from the perspective of cancer consumers and clinical trialists: a qualitative study."
Background
There is growing concern among international stakeholders that the cancer clinical trial community has defaulted to specific full-length, legacy PROMs.
These PROMS may not always measure key domains of health-related quality of life (HRQoL) relevant for specific studies, contexts, populations, and stakeholders. They may also include irrelevant domains, posing ethical concerns by needlessly burdening unwell patients.
In response, there has been recent interest in a “modular approach,” where only a subset of domains (i.e., subscales) from multi-scaled PROMs are administered.
Although this approach reduces patient burden and allows flexible assessment, it may overlook important HRQoL issues and hinder comparability with studies using the full instrument.
There is also uncertainty about including sufficient domains to estimate utility values for cost-utility analysis, particularly from nested preference-based measures derived from legacy PROMs.
A modular approach also requires more effort on the part of investigators to thoughtfully consider the likely benefits and disadvantages of the treatment they are trialing in order to target specific concepts/variables.
Despite detailed recommendations from international stakeholders and PROM developers, we have yet to see widespread uptake of the modular approach in cancer clinical trials. It remains unclear how acceptable the modular approach is to consumers and clinical trialists.
It is possible that despite emerging evidence supporting the modular approach, stakeholders will continue to prefer the traditional approach as the least risky option.
Goals
This qualitative study will explore the acceptability of the modular approach in administering PROMs from the perspective of cancer consumers and trialists.
Our goal is to find out the perspectives of clinical trialists and consumers regarding the use of the modular approach in cancer clinical trials. By gaining a deeper understanding of their attitudes, we can identify facilitators and barriers to the approach, which can be addressed to improve its acceptability and inform future research efforts.
Understanding the perspectives of trialists and consumers is crucial in assessing the potential for a paradigm shift in trial design towards tailored PROM administration and the level of support needed to shift attitudes. It also provides valuable information for funding panels and regulatory agencies to understand the needs and demands of trialists and consumers. Our findings may encourage other researchers to further explore how well the modular approach measures what it is supposed to and how consistent and accurate it is.
Research Impact
We plan to disseminate our research findings through conference presentations and workshops organised by the Cancer Cooperative Trials Groups (CCTGs), with which the applicants are closely associated. Engaging the scientific community is anticipated to generate interest among researchers to adopt and test the modular approach.
We are also involved in the development of clinical trial concepts by the CCTGs and will be able to assess the degree of uptake and changes in attitudes toward the modular approach.
Our mentors serve as co-chairs of the Cancer Quality of Life Expert Services Team (CQUEST). CQUEST provides expert advice to the CCTGs about the inclusion of PROMs in cancer clinical trials and are well positioned to address facilitators and barriers to the integration of the modular approach.
The findings from this study are expected to provide a robust foundation for understanding the acceptability of modular PROMs among cancer trial stakeholders. This could pave the way for more targeted and less burdensome assessments in clinical trials, ultimately enhancing patient experience and data relevance.
The project also holds promise for influencing policy changes and guiding future clinical trial designs to incorporate more flexible and patient-centred outcome measures. This knowledge is essential for assessing the potential for a shift in trial design towards more tailored PROM administration and determining the support needed to change attitudes.
Byline: Dr Carrie-Anne Ng and Dr Mariana Sousa
About us
Carrie-Anne and Mariana bring complementary expertise to this project. Carrie-Anne is a health economist at the Centre for Health Economics Research and Evaluation (CHERE). She has expertise in the adaptation and development of PROMs for both clinical efficacy and economic evaluation.
Mariana is a clinical trialist with the Palliative Care Clinical Studies Collaborative (PaCCSC). She has a strong clinical background working with people with advanced cancer and an intimate understanding of cancer symptom burden
Both Carrie-Anne and Mariana have strong collaborative connections with cancer clinical trial groups in Australia, which will be invaluable when recruiting interviewees from different disease and clinical backgrounds.