Improving Access to Lung Cancer Clinical Trials

NCT05780164 | Recruiting

• 1 other identifier: IRAS Ref: 325757
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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; Patient Engagement; Research, Communication; Nurse-Patient Relations; Recruitment

Keywords

patient engagement; research, communication; clinical trials; nurse-patient relations; recruitment; lung cancer

Outcome Measures

Primary Outcomes (3)

• Perceived self-efficacy of nurses ability to discuss clinical trials with lung cancer patients

  Items from the validated General Perceived Self-Efficacy Scale will measure lung cancer nurses' self-efficacy in relation to their research.

  Data will be collected from each LCN (n=36) at baseline, three and six months.

• Perceived self-efficacy of nurses ability to discuss clinical trials with lung cancer patients

  Items from the validated General Perceived Self-Efficacy Scale will measure lung cancer nurses' self-efficacy in relation to their research.

  Data will be collected from each LCN (n=36) at three months.

• Perceived self-efficacy of nurses ability to discuss clinical trials with lung cancer patients

  Items from the validated General Perceived Self-Efficacy Scale will measure lung cancer nurses' self-efficacy in relation to their research.

  Data will be collected from each LCN (n=36) at six months.

Secondary Outcomes (6)

• 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.

• 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 baseline.

• Nurses' knowledge, confidence and awareness of clinical trials

  Data will be collected from each LCN (n=36) at three months.

Study Arms (2)

Intervention

Nurse participants will be provided with a research readiness tool to facilitate their discussions with lung cancer patients about clinical trial opportunities. The tool will be used by nurses over a six month period, alongside usual care.

Other: Research readiness tool

Control

No intervention. Nurse participants will provide usual care to lung cancer patients.

Interventions

Research readiness tool OTHER

Online/paper based tool containing information about lung cancer clinical trials

Intervention

Eligibility Criteria

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

Study Population

Lung cancer patients, carers and healthcare professionals

You may qualify if:

• 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

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 role
• Employed as a lung cancer research delivery nurse

Sponsors & Collaborators

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

Study Sites (1)

Faculty of Health and Life Sciences, Oxford Brookes University

Oxford, Oxfordshire, United Kingdom

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Patient Participation; Communication

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Catherine L 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: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader in Nursing

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 22, 2023
• Study Start: July 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

GB (1)