Trial Title:
Improving Access and Recruitment to Clinical Trials for Lung Cancer Patients
NCT ID:
NCT05888584
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
lung cancer
nurses
research
clinical trials
recruitment
access
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Research readiness tool
Description:
Online/paper based tool for use by nurses to aid discussions with lung cancer patients
about clinical trials opportunities.
Arm group label:
Intervention tool
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Derby and Burton NHS
Address:
City:
Derby
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Monica Hugh
Investigator:
Last name:
Monica Hugh
Email:
Principal Investigator
Facility:
Name:
St Bartholomews Hospital NHS
Address:
City:
London
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Adam Januszewsk
Investigator:
Last name:
Adam Januszewsk
Email:
Principal Investigator
Investigator:
Last name:
Bing Smith
Email:
Sub-Investigator
Facility:
Name:
The Royal Marsden NHS
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Sarah Sarker
Investigator:
Last name:
Sarah Sarker
Email:
Principal Investigator
Facility:
Name:
The Christie NHS
Address:
City:
Manchester
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Jackie Fenemore
Investigator:
Last name:
Jackie Fenemore
Email:
Principal Investigator
Facility:
Name:
Sherwood Forest NHS
Address:
City:
Nottingham
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
June Morley
Investigator:
Last name:
June Morley
Email:
Principal Investigator
Facility:
Name:
Oxford University Hospitals
Address:
City:
Oxford
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Najib Rahman
Investigator:
Last name:
Najib Rahman
Email:
Principal Investigator
Facility:
Name:
Royal Surrey County Hospital
Address:
City:
Guildford
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Agnieszka Kehinde
Investigator:
Last name:
Agnieszka Kehinde
Email:
Principal Investigator
Facility:
Name:
Sheffield Teaching Hospitals NHS
Address:
City:
Sheffield
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Andrea Sorsby
Investigator:
Last name:
Andrea Sorsby
Email:
Principal Investigator
Facility:
Name:
Lanarkshire NHS
Address:
City:
Glasgow
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
John McPhelim
Investigator:
Last name:
John McPhelim
Email:
Principal Investigator
Start date:
July 1, 2023
Completion date:
March 30, 2025
Lead sponsor:
Agency:
Oxford Brookes University
Agency class:
Other
Collaborator:
Agency:
De Montfort University
Agency class:
Other
Source:
Oxford Brookes University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05888584
