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.