Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05888584
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2023-05-12
Brief Title:
Improving Access and Recruitment to Clinical Trials for Lung Cancer Patients
Sponsor:
Oxford Brookes University
Organization:
Oxford Brookes University
Study Overview
Official Title:
Improving Access and Recruitment to Clinical Trials for Lung Cancer Patients
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LungI-ACT
Brief Summary:
There are 85000 lung cancer patients LCPs in the UK yet only around 8 were recruited into clinical trials in 202122 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 12 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
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 12 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 67057 in 201718 to 27734 in 20202021 78 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 patientcarer 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 12 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 DerbyBurton Lanarkshire Nottinghamshire An additional two NHS sites Surrey and Birmingham will act as controls
Each sites LCNs n36 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 n24 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 n36 at baseline three and six months and LCNs 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 12 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 n36
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 tools acceptability in terms of ease of use and impact on recruitment
Eight patientscarers 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 tools impact on LCP experience
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 patientcarer 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 12 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 DerbyBurton Lanarkshire Nottinghamshire An additional two NHS sites Surrey and Birmingham will act as controls
Each sites LCNs n36 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 n24 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 n36 at baseline three and six months and LCNs 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 12 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 n36
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 tools acceptability in terms of ease of use and impact on recruitment
Eight patientscarers 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 tools impact on LCP experience
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None