Improving Access and Recruitment to Clinical Trials for Lung Cancer Patients

NCT05888584 | Recruiting

• 1 other identifier: IRAS project ID: 325757
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 9

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.

Conditions

Lung Cancer

Keywords

lung cancer; nurses; research; clinical trials; recruitment; access

Outcome Measures

Primary Outcomes (1)

• self-efficacy

  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.

  six months

Secondary Outcomes (4)

• 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

Study Arms (2)

Intervention tool

EXPERIMENTAL

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.

Other: Research readiness tool

Control

NO INTERVENTION

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.

Interventions

Research readiness tool OTHER

Online/paper based tool for use by nurses to aid discussions with lung cancer patients about clinical trials opportunities.

Intervention tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not actively involved in frontline clinical care
• Not involved in caring for lung cancer patients for at least 30% of their
• Patients/carers:
• 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
• Mesothelioma diagnosis or caring for someone with a mesothelioma diagnosis
• Unable to provide informed consent
• Phase 4 Healthcare professionals
• 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
• Not actively involved in frontline clinical care
• Not involved in caring for lung cancer patients for at least 30% of their role

Sponsors & Collaborators

• Oxford Brookes University: lead
• De Montfort University: collaborator

Study Sites (9)

Derby and Burton NHS

Derby, Derbyshire, United Kingdom

RECRUITING

St Bartholomews Hospital NHS

London, Greater London, United Kingdom

NOT YET RECRUITING

The Royal Marsden NHS

London, Greater London, United Kingdom

RECRUITING

The Christie NHS

Manchester, Greater Manchester, United Kingdom

RECRUITING

Sherwood Forest NHS

Nottingham, Nottinghamshire, United Kingdom

RECRUITING

Oxford University Hospitals

Oxford, Oxfordshire, United Kingdom

RECRUITING

Royal Surrey County Hospital

Guildford, Surrey, United Kingdom

NOT YET RECRUITING

Sheffield Teaching Hospitals NHS

Sheffield, Yorkshire, United Kingdom

RECRUITING

Lanarkshire NHS

Glasgow, United Kingdom

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Catherine Henshall, PhD

  Oxford Brookes University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine L Henshall, PhD

CONTACT

07778 428994; chenshall@brookes.ac.uk

Iain Williamson, PhD

CONTACT

iwilliamson@dmu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Catherine Henshall

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: June 5, 2023
• Study Start: July 1, 2023
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (9)