Clinical trial NCT05888584: Improving Access and Recruitment to Clinical Trials for Lung Cancer Patients
Official title: Improving Access and Recruitment to Clinical Trials for Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: lung cancer
nurses
research
clinical trials
recruitment
access
Lead sponsor: Oxford Brookes University
Sponsor class: OTHER
Collaborators: name: De Montfort University
First posted: 2023-06-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: There are \~85,000 lung cancer patients (LCPs) in the UK; yet only around 8% were recruited into clinical trials in 2021/22. LCPs need opportunities to take part in clinical trials to access new treatments, increasing their quality of life, treatment choices and life expectancy.

Discussions with nurses can help patients make better treatment decisions, improving experiences of care. However, research has shown that lung cancer nurses (LCNs) often feel unable to discuss participation in trials with patients due to lack of knowledge, confidence, time and training.

This study aims to develop and test a research recruitment tool for LCNs, to support LCPs to enter clinical trials.

Objectives include to:

* Explore reasons for low uptake of LCPs into clinical trials
* Develop a tool for LCNs to talk to patients about clinical trials
* Test whether the tool improves the number and quality of discussions nurses have with LCPs about clinical trials

The study has four phases:

Phase 1: A literature review will identify problems that make clinical trial uptake difficult for LCPs, carers and clinicians

Phase 2: Six group discussions with LCNs, patients and carers will explore issues that create potential barriers for patients taking part in clinical trials. The groups will take place online, last approximately one hour and be recorded.

Phase 3: Part 1\&2 findings will help us develop a LCN research recruitment tool. The tool will contain information on how nurses obtain information about LC clinical trials, research teams, communication issues, practical issues and how to reach LCPs.

Phase 4: The research recruitment tool will be tested in four UK NHS hospitals. A survey will identify any changes in nurses' clinical trials awareness and confidence before and after using the tool. Interviews with LCNs, patients and carers will explore their views on the tool, clinical trials participation and experiences of care.

Detailed description: 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.

Eligibility criteria: Healthcare staff Phase 2:

Inclusion Criteria:

* Actively involved in the clinical care pathways of lung cancer patients
* Working at one of the six participating NHS trusts
* Age between 18-65 years of age

Exclusion criteria:

* Not actively involved in frontline clinical care
* Not involved in caring for lung cancer patients for at least 30% of their

Patients/carers:

Inclusion criteria:

* Must have a current diagnosis of lung cancer (any stage) or be the named carer of a person with a lung cancer diagnosis
* Under the care of (or caring for) one of the participating NHS Trusts lung cancer teams
* Aged 18 or over

Exclusion criteria:

* Mesothelioma diagnosis or caring for someone with a mesothelioma diagnosis
* Unable to provide informed consent

Phase 4 Healthcare professionals

Inclusion criteria:

* Registered nurse with Nursing and Midwifery Council
* Actively involved in the clinical care pathways of lung cancer patients
* Working at one of the six participating NHS trusts
* Age between 18-65 years of age

Exclusion criteria:

* Not actively involved in frontline clinical care
* Not involved in caring for lung cancer patients for at least 30% of their role
* Employed as a lung cancer research delivery nurse

Patients/carers:

Inclusion criteria:

* Current diagnosis of lung cancer (any stage) or be the named carer of a person with a lung cancer diagnosis
* Aged 18 or over
* Consented to (or carer of someone who has consented to) a clinical trial since start of pilot study
* Receiving care (or carer for someone receiving care) in one of the four NHS sites piloting the research readiness tool

Exclusion criteria:

* Mesothelioma diagnosis or caring for someone with a mesothelioma diagnosis
* Unable to provide informed consent

Primary outcomes:
measure: self-efficacy
timeFrame: six months
Secondary outcomes:
measure: research contacts with lung cancer patients
timeFrame: six months
measure: lung cancer nurses' clinical trials knowledge
timeFrame: six months
measure: lung cancer nurses' clinical trials confidence
timeFrame: six months
measure: lung cancer nurses' clinical trials awareness
timeFrame: six months
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: Derby and Burton NHS
state: Derbyshire
city: London
country: United Kingdom
facility: St Bartholomews Hospital NHS
state: Greater London
city: London
country: United Kingdom
facility: The Royal Marsden NHS
state: Greater London
city: Manchester
country: United Kingdom
facility: The Christie NHS
state: Greater Manchester
city: Nottingham
country: United Kingdom
facility: Sherwood Forest NHS
state: Nottinghamshire
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals
state: Oxfordshire
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
state: Surrey
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS
state: Yorkshire
city: Glasgow
country: United Kingdom
facility: Lanarkshire NHS
Study officials:
affiliation: Oxford Brookes University
name: Catherine Henshall, PhD
role: PRINCIPAL_INVESTIGATOR
References: