PurposeChemoradiation therapy (CRT) for patients with locally advanced pancreatic cancer (LAPC) provides survival benefits but may result in considerable toxicity. Health-related quality of life (HRQL) measurements during CRT have not been widely reported. This paper reports HRQL data from the Selective Chemoradiation in Advanced Localised Pancreatic Cancer (SCALOP) trial, including validation of the QLQ-PAN26 tool in CRT.Methods and MaterialsPatients with locally advanced, inoperable, nonmetastatic carcinoma of the pancreas were eligible. Following 12 weeks of induction gemcitabine plus capecitabine (GEMCAP) chemotherapy, patients with stable and responding disease were randomized to a further cycle of GEMCAP followed by capecitabine- or gemcitabine-based CRT. HRQL was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EORTC Pancreatic Cancer module (PAN26).ResultsA total of 114 patients from 28 UK centers were registered and 74 patients randomized. There was improvement in the majority of HRQL scales during induction chemotherapy. Patients with significant deterioration in fatigue, appetite loss, and gastrointestinal symptoms during CRT recovered within 3 weeks following CRT. Differences in changes in HRQL scores between trial arms rarely reached statistical significance; however, where they did, they favored capecitabine therapy. PAN26 scales had good internal consistency and were able to distinguish between subgroups of patients experiencing toxicity.ConclusionsAlthough there is deterioration in HRQL following CRT, this resolves within 3 weeks. HRQL data support the use of capecitabine- over gemcitabine-based chemoradiation. The QLQ-PAN26 is a reliable and valid tool for use in patients receiving CRT.
Introduction
Clinical trials must include diverse participants to ensure the wide applicability of results. However, people from ethnic minorities are included in clinical trials at rates lower than expected given their share of the population. Working with South Riverside Community Development Centre (SRCDC), Talking Trials used public engagement to foster discussions around the underrepresentation of those from minority ethnic communities in clinical trials and to identify and address concerns surrounding trial participation.
Methods
We conducted three workshops with 13 co‐researchers from minority ethnic backgrounds. We explored perceptions and understanding of clinical trials alongside participatory art activities to help move away from verbocentric methods of communication. These artworks formed an exhibition that was presented to the community, prompting further discussions and engagement.
Findings
Co‐production workshops were an effective tool to introduce the public to trial research. With little knowledge of clinical trials at the beginning of the process, our co‐researchers formed a cohesive group, sharing initial fears and mistrust towards trials. As conversations progressed these attitudes clearly shifted. Artwork produced during the workshops was incorporated into an exhibition. Quotes and creative pieces from the group were included to reflect the themes identified. Presenting the exhibition at Riverside Festival enabled further engagement with a wider diverse community. The focus on co‐production helped build a network of individuals new to research and keen to become involved further.
Conclusion
Inclusive and democratic co‐production, enriched by participatory art practices, provided a powerful means of enabling our group to create new insights and foster new relationships. Projects like Talking Trials can diversify the research process itself—for example, four co‐researchers have commenced lay research partner roles on trial management groups and a lay advisory group is in development.
Patient or Public Contribution
Three members of staff at SRCDC were on the project delivery group and involved in the initial project design, subsequently helping to connect us with members of the Riverside community to work as co‐researchers. Two of the SRCDC staff are co‐authors of this manuscript. The project had 13 public co‐researchers guiding the direction of this research and creating the artwork displayed in the art exhibition.
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