Improving Access and Recruitment to Clinical Trials for Lung Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Oxford Brookes University
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Perceived self-efficacy of nurses ability to discuss clinical trials with lung cancer patients
Study Overview
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
Study design: This mixed methods study consists of the following phases:
Phase 1: systematic review exploring barriers and challenges to clinical trial uptake among LCPs, carers and clinicians
Phase 2: focus groups with LCPs, carers, LCNs, research nurses and multidisciplinary teams to explore challenges, barriers and facilitators to clinical trial uptake among LCPs
Phase 3: development of a research recruitment tool for LCNs to facilitate recruitment of LCPs into clinical trials Phase 4: pilot study to test the effectiveness and acceptability of the research recruitment tool across four NHS trusts (including interviews with LCPs, carers and LCNs).
Phase 1: A systematic review of the best scientific literature will identify challenges and barriers to clinical trial recruitment amongst LCPs, carers and clinicians. The research team have experience in conducting systematic reviews and share multi-disciplinary knowledge and expertise. A recent scoping exercise identified multiple papers examining recruitment to LC clinical trials; our review will be more extensive and rigorous in terms of databases searched, search terms, languages included, quality reviews of potential papers included and time period. PRISMA reporting guidelines will be followed.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Perceived self-efficacy of nurses ability to discuss clinical trials with lung cancer patients
Time Frame: Data will be collected from each LCN (n=36) at six months.
Items from the validated General Perceived Self-Efficacy Scale will measure lung cancer nurses' self-efficacy in relation to their research.
Perceived self-efficacy of nurses ability to discuss clinical trials with lung cancer patients
Time Frame: Data will be collected from each LCN (n=36) at baseline, three and six months.
Items from the validated General Perceived Self-Efficacy Scale will measure lung cancer nurses' self-efficacy in relation to their research.
Perceived self-efficacy of nurses ability to discuss clinical trials with lung cancer patients
Time Frame: Data will be collected from each LCN (n=36) at three months.
Items from the validated General Perceived Self-Efficacy Scale will measure lung cancer nurses' self-efficacy in relation to their research.
Secondary Outcomes
- number of Lung cancer patients each nurse has approached to discuss clinical trial opportunities(Data will be collected from each Lung Cancer Nurse (n=36) at six months)
- Nurses' knowledge, confidence and awareness of clinical trials(Data will be collected from each LCN (n=36) at six months.)
- number of Lung cancer patients each nurse has approached to discuss clinical trial opportunities(Data will be collected from each Lung Cancer Nurse (n=36) at baseline.)
- number of Lung cancer patients each nurse has approached to discuss clinical trial opportunities(Data will be collected from each Lung Cancer Nurse (n=36) at three months.)
- Nurses' knowledge, confidence and awareness of clinical trials(Data will be collected from each LCN (n=36) at baseline.)
- Nurses' knowledge, confidence and awareness of clinical trials(Data will be collected from each LCN (n=36) at three months.)
Investigators
Dr Cathy Henshall
Reader in Nursing
Oxford Brookes University