Improving Access and Recruitment to Clinical Trials for Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 17
- 主要终点
- self-efficacy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention tool
A research recruitment tool will be available in paper and online formats and 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. The tool will be used by lung cancer nurses in their daily practice as an aid to support their discussions with lung cancer patients about clinical trial opportunities. They will be asked to complete a survey at three time-points (baseline, three and six months) to measure their self-efficacy, knowledge, confidence and awareness in talking to lung cancer patients about clinical trials.
干预措施: Research readiness tool (Other)
Control
Lung cancer nurses will undertake usual care. They will be asked to complete a survey at three time-points (baseline, three and six months) to measure their self-efficacy, knowledge, confidence and awareness in talking to lung cancer patients about clinical trials.
结局指标
主要结局
self-efficacy
时间窗: six months
Data will be collected from each lung cancer nurse (n=36) at baseline, three and six months. Items from the validated General Perceived Self-Efficacy Scale (GSE) will measure LCNs' self-efficacy in relation to their research. The total score is calculated by finding the sum of the all items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
次要结局
- research contacts with lung cancer patients(six months)
- lung cancer nurses' clinical trials knowledge(six months)
- lung cancer nurses' clinical trials confidence(six months)
- lung cancer nurses' clinical trials awareness(six months)
研究者
Dr Cathy Henshall
Professor Catherine Henshall
Oxford Brookes University