Improving Access and Recruitment to Clinical Trials for Lung Cancer Patients

Background: Patients who discuss taking part in research and those that go on to participate have better outcomes and experiences. Reported trial benefits for patients include greater access to new drugs; disease control; improved survival; enhanced quality of life; more intensive follow up and monitoring; better symptom management; enhanced care and support; and patient empowerment. In cancer care, the rate at which targeted treatments are translated into clinical practice for use by LCPs is reliant on accessible clinical trial opportunities; however, trial uptake remains low. Recruitment to research within the UK National Health Service (NHS) is challenging and COVID-19 saw a 59% reduction in cancer patients entering clinical trials in England, from 67,057 in 2017/18 to 27,734 in 2020/2021 [7,8]. Resultingly, the Institute of Cancer have recommended that trial information is made accessible and understandable to patients and that clinical staff have conversations about trials early in the treatment pathway.

Being assigned a LC clinical nurse specialist is associated with better experiences of care and studies have found that discussions nurses have with patients about clinical trial enrolment play a key role in decision-making and recruitment. However, LCNs often feel unable to discuss clinical trials with patients due to a lack of knowledge and confidence, time, expertise and training. Key barriers to trial recruitment include screening complexities; lack of resources, staff, skills and equipment; time; limited clinician awareness; perceived administrative burdens, concerns over trial suitability; inadequate information communicated to patients and clinicians and complex trial terminology. It is recommended that clinical trials are more closely integrated into clinical practice and that staff are adequately trained to support clinical research.

Study design: This mixed methods study consists of the following phases:

Phase 1: A systematic review of the best scientific literature will identify challenges and barriers to clinical trial recruitment amongst LCPs, carers and clinicians. PRISMA reporting guidelines will be followed.

Phase 2: Six qualitative focus groups with lung cancer patients, carers, lung cancer nurses and other members of the multidisciplinary team (MDT) will explore challenges and facilitators to LCPs' clinical trial entry. Focus group participants will be recruited through the participating sites lung cancer nursing teams.

Eligible clinician participants (nurses and other MDT staff) will be contacted through lead LCNs at participating sites (see phase 4), who will share invitation letters and participant information leaflets with their teams. If they are happy to proceed a researcher will organise a time, date and place with participants to proceed with the focus group. Participants will also be recruited through LCNUK and the National Institute for Health Research (NIHR) Local Clinical Research Networks.

Patients and carers will be recruited through the NCRI consumer forum and other cancer patient/carer networks, including RCLCF and Mesothelioma UK. LCNs at participating NHS sites will also share invitation letters and information leaflets with LCPs, inviting them to take part. If they are happy to proceed the researcher will organise a time, date and place with participants to proceed with the focus group. The study will also be promoted via social media channels such as Twitter, Healthcare Unlocked and closed Facebook groups. We intend to recruit ~48 participants to focus groups (eight per group); three focus groups will be with LCNs, research nurses and multidisciplinary team members from district general hospitals (DGHs) and tertiary centres, and two with LCPs and carers. A final group will include clinicians from the Christie and Royal Marsden cancer centres, where recruitment to trials is higher than in DGHs and tertiary centres, to identify transferable elements of best practice. Focus groups will be held remotely, via the online Zoom platform.

Focus groups facilitated by two researchers, will last one hour, and will be recorded and transcribed. Data will be thematically analysed using the Framework Method, to enable comparisons across groups to be identified and themes generated.

Phase 3: Phase 1\&2 findings will inform development of the LCN research recruitment tool. The tool, available in paper and online formats, will include information on finding out about LC clinical trials, the role of research teams, embedding research into multidisciplinary team meetings and health needs assessments, communication pathways, signposting LCPs, practical considerations and reaching underrepresented groups. Tool development will be guided by the Trial Steering Group (TSG), with representation from LC patient and public involvement (PPI) members, LCNs, multidisciplinary research and clinical teams. The tool will be tested for face and content validity by ~10 LCNs who participated in Phase 2, and ~4 PPI representatives. Relevant feedback will be used to make modifications to the tool.

Phase 4 pilot: Participants in the pilot study will pilot the research recruitment tool for proof of concept across four UK NHS sites, including tertiary centres and DGHs: Oxford, Derby\&Burton, Lanarkshire, Nottinghamshire. An additional two NHS sites, Surrey and Birmingham, will act as controls.

Each site's LCNs (n=36) will be invited to participate through their senior nurse manager who will provide eligible nurses with an online invitation letter and participant information sheet (PIS). If they are happy to proceed the researcher will organise a time, date and place with participants for the pilot phase of the study. Nurse participants will then have a briefing session, where the pilot study purpose will be explained. LCNs at the pilot sites (n=24) will be provided with a training session on using the tool, before implementing it in their teams for six months.

Survey data will be collected from each LCN (n=36) at baseline, three and six months and LCN's will reconsent electronically, via the Qualtrics survey platform, prior to completing each online survey. The survey will collect information on the following: 1) Items from the validated General Perceived Self-Efficacy Scale will measure LCNs' self-efficacy (primary outcome measure) in relation to their research roles 2) The number of LCPs each LCN has approached to discuss clinical trial opportunities will be recorded 3) Likert style survey data on LCNs' knowledge, confidence and awareness of clinical trials will be collected. These questions will be developed from phase 1\&2 findings and tested for reliability and validity by TSG members. The repeated tests measure ANOVA will compare survey responses between baseline, three and six months. Between groups ANOVA will compare differences in scores between pilot and control sites. No formal sample size calculation is required as this is a pilot study; however, all LCNs across the six sites will be invited to take part (n~36).

Towards the end of the pilot, eight LCNs who have been taken part in the pilot will be invited, via an invitation letter and participant information sheet provided by the research team, to attend a 30-minute interview, via the online Zoom platform, or via telephone, to explore the tool's acceptability, in terms of ease of use and impact on recruitment.

Eight patients/carers who have joined clinical trials at the pilot sites will also be interviewed remotely, via the online Zoom platform or by telephone to explore their clinical trial experience and its impact on quality of life, care satisfaction, self-efficacy and symptom control will be explored. This will provide valuable information on the tool's impact on LCP experience.