Improving Access and Recruitment to Clinical Trials for Lung Cancer Patients: A Multi-Phase, Qualitative Focus Group and Co-Production Study.

[AIM] To design and develop a novel co-produced intervention tool aimed at facilitating discussions that lung cancer nurses have with lung cancer patients about clinical trial opportunities; and promote trial recruitment.

[DESIGN] A multi-phase qualitative focus group (phase 1) and co-production (phase 2) study.

[METHODS] The rigorous design and content of the intervention tool was informed by qualitative data from seven focus groups with lung cancer healthcare professionals (n = 38) and patients and their carers (n = 22) to establish barriers and facilitators to clinical trial participation. Data collection took place across England and Scotland between October and December 2023. Findings from a previously published systematic review were also incorporated to inform intervention tool design. The tool was developed through an extended co-production workshop comprising lung cancer nurses (n = 7), lung cancer patients (n = 2) and health researchers (n = 4). The COM-B model of behavioural change underpinned both phases of the project to guide tool development.

[RESULTS] Phase 1 focus groups identified the need for a tool to provide basic trial information to patients, and to support lung cancer nurses in discussing trials with patients, thus improving nurses' knowledge, confidence, and awareness of trials. The phase 2 coproduction workshop identified that the tool should consist of two elements: a patient-facing information pamphlet and a large poster for nurses to assist them in discussing trial opportunities.

[CONCLUSION] The study results demonstrate how nurses can be supported to discuss clinical trial opportunities with patients, with the potential to increase long-term recruitment to clinical trials.

[IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE] Lung cancer nurses often lack confidence to support patients to make informed choices about trial enrolment. By addressing this issue, participation in lung cancer clinical trials can be significantly improved to benefit patient outcomes and trial participation rates.

[IMPACT] The tool has the potential to be used across a range of different cancer settings and sites to increase recruitment to clinical trials.

[REPORTING METHOD] The COREQ checklist was utilised to ensure that robust processes were followed and reported on.

[PATIENT AND PUBLIC INVOLVEMENT] Patients and members of the public were involved in all study processes and contributed to the study design, interpretation of the data, and intervention design. Their contributions included reviewing focus group topic guides, reviewing data analysis, the co-production of the intervention tool, and co-authoring this paper, ensuring the research addressed the needs and priorities of lung cancer patients when making an informed choice about clinical trial participation.