Blood and Lymph Conditions

All Conditions

Neoplasms

Heart and Blood Diseases

Rare Diseases

Myeloproliferative Disorders

Polycythemia Vera

Polycythemia

Primary Myelofibrosis

Thrombocytosis

Thrombocythemia, Essential

Bone Marrow Diseases

Hematologic Diseases

Bone Marrow Neoplasms

Hematologic Neoplasms

Blood Platelet Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Hemorrhagic Disorders

Chronic Myeloproliferative Disorders

Essential Thrombocythemia

Patients with Polycythemia vera (PV), essential thrombocythemia (ET) and primary myelofibrosis (PMF) will be recruited based on the WHO diagnostic criteria.

Exclusion Criteria

* younger than 18 years old.
* where the clinician/General Practitioner (GP) does not provide consent.
* incapable of giving informed consent.
* physically or cognitively incapable of completing the questionnaire.
* too ill to participate.

We will assess whether a pen (branded, non-branded or none), a £10 cheque and/or a charity branded trolley token will affect uptake rates in the study.

GP controls will be randomly selected and frequency matched to the distribution of cases by 5-year age band, geographic location (Belfast and Southampton) and gender.

The following patient groups will be excluded. Those:

* younger than 18 years old.
* where the clinician/GP does not provide consent.
* incapable of giving informed consent.
* physically or cognitively incapable of completing the questionnaire.
* too ill to participate.

We will assess whether a pen (branded, non-branded or none), a £10 cheque (at study completion) and/or a charity branded trolley token will affect uptake rates in the study.

Recruitment of 100 non-blood relative/friend controls will be undertaken by asking cases to pass on a flyer to up to 2 or 3 non-blood relatives/friends aged 18 years or older.

We will assess whether a pen (branded, non-branded or none) and/or a £10 cheque (at study completion) will affect uptake rates in the study. Only a limited number of trolley tokens were available so not assessed in this group.

Randomisation of branded pen, non-branded pen and no pen

Methodological pens

Randomisation of a £10 monetary reimbursement for expenses on completion of the study

Methodological compensation

Trolley tokens to be randomly assigned to half of cases and General Practice controls.

Methodological trolley tokens

Lesley A Anderson, PhD

There is a paucity of data on the aetiology of myeloproliferative neoplasms (MPNs). The investigators conducted a systematic review of the literature which identified several cohort and case-control studies that have investigated a wide range of potential medical, environmental and occupational risk factors. However, these studies have been limited by a wide variation in case definition and small sample sizes limiting the potential to detect modest risk differences between cases and controls. The research group propose an exploratory case-control study of 100 patients with classic MPNs and 200 controls to determine the optimal methods for roll out of this study to a multi-centred UK-based case-control study that will investigate the aetiology of MPN subtypes. The objectives of the study are to evaluate recruitment procedures, response rates and the development of a telephone administered questionnaire. The findings of this exploratory study will form the basis of a protocol for a large United Kingdom (UK)-wide case-control study of MPNs.

MPNs are a group of haematopoietic malignancies resulting from a transformed haematopietic progenitor cell. They are characterised by overproduction of mature functional blood cells. MPNs were historically termed myeloproliferative disorders and have undergone numerous amendments in classification. The 2008 World Health Organisation (WHO) classifies a number of related disorders as MPNs including polycythemia vera (PV), essential thrombocythemia (ET) and primary/idiopathic myelofibrosis (PMF)2. Reported incidence rates vary from 0.02 to 2.8 per 100,000 persons3-5 but are not well characterised with half of patients asymptomatic at diagnosis6. In Northern Ireland (NI) the prevalence of ET is reported to be 18 per 100,000 persons (by correspondence, Mary McMullin). PV and ET are indolent neoplasms with better prognosis (88% and 92% 3-year survival, respectively) compared to PMF which has a 63% 3-year survival in the United States5.

The main study objectives are to:

* Develop a telephone-based questionnaire to investigate potential risk factors associated with MPNs.
* Assess the reliability and validity of the study questionnaire.
* Determine which control group to investigate by investigating:

  * Response rates.
  * Representativeness of control groups.
* Assess recruitment procedures.
* Determine if offering reimbursement of expenses (£10 per person) encourages control participation and improved representativeness to the general population.

A case-control approach was chosen as it is the most cost-efficient method of obtaining information on the aetiology of rare diseases such as MPNs. A prospective cohort study would require participation from millions of individuals followed over a long period of time. A hospital-based approach was chosen over a population-based approach to ensure the study was more feasible and could be rolled out to a number of centres in the UK.

The disorders under investigation are:

* Polycythaemia vera
* Essential Thrombocythaemia
* Primary myelofibrosis

Initially there will be one site in Belfast, Northern Ireland and one in Southampton, England. Cases will be identified and recruited through Prof Mary Frances McMullin at the Belfast City Hospital (BCH), Belfast Health and Social Care Trust, Northern Ireland and Dr Andrew Duncombe, at the University Hospital Southampton NHS Foundation Trust (UHS), Southampton, England.

Following completion of the exploratory study it is planned that other sites across the UK will be invited to participate through the Clinical Research Network.

. CASE ASCERTAINMENT Recruitment will run over a 12 month period. It is estimated that at least 100 incident and prevalent MPN cases will be recruited from the two sites during this time frame; 50 from Belfast, NI and 50 from Southampton, England. The targeted distribution of cases projected as feasible is 40 PV, 40 ET and 20 PMF cases. Fewer PMF cases are expected as the incidence is lower than PV and ET. Both incident and prevalent cases will be recruited in the exploratory case-control study and the distribution of time since diagnosis evaluated. One of the main limitations of including prevalent cases is that risk factors may differ in those who survive for a long period after diagnosis compared to those who die soon after diagnosis. Since PV and ET have low mortality rates it is expected that this will not impact the evaluation of the aetiology of these conditions to a large extent. However for PMF, which has a higher mortality rate than PV or ET, cases will be recruited as close to diagnosis as possible.

Eligible cases will be identified by the two lead clinicians Prof McMullin (Belfast) and Dr Duncombe (Southampton) during attendance at their routine clinics. Prof McMullin and Dr Duncombe will ensure that potential cases meet the study inclusion criteria (section 2.5) and provide detailed information on the categorisation of the case (PV, ET, PMF), which diagnostic criteria have been met and the clinical history of the patient.

Patients will be invited to participate in the study by letter from their lead clinician with an information sheet. Non-respondents will be randomised to either receive a reminder letter or a telephone contact from their health care team.

The choice of control group is an important consideration in any case-control study. Controls recruited from the general population through General Practitioners, population registers, neighbourhood controls or random digit dialling are ideal at identifying a representative sample of the population from which the case population was identified. However, these groups often have low response rates and selection bias is inferably encountered. Other control groups such as friend, family or hospital controls have much higher response rates but the factors associated with friendship, family or being in hospital may mean that these groups are less representative of the general population. For the purposes of this study two control groups will be recruited; GP controls and non-blood relatives (including spouses) or friend controls. The study will investigate response rates, differences in study characteristics between control groups and generalisability to the population using population-based statistics.

2.8.1 GP Controls Within each study site 5 GPs, reflective of the geographic distribution of MPN cases, will be approached to facilitate the identification and recruitment of controls and for performing phlebotomy. Each practice will be offered £200 for participation in the study.

2.8.1.1 Northern Ireland Control Recruitment in Northern Ireland will be conducted with the help of the Northern Ireland Clinical Research Network (Primary Care) (NICRN (PC)) who work in partnership with GP practices to provide support, guidance and facilitate research. The NICRN nurses who work with practices hold a Confidentiality Agreement and honorary contract with the practice. Practices are supplied with a study file, which is kept in a secure location at the practice and contains the study protocol and all relevant study information including the completed Research Governance form and contact details of researchers and NICRN (PC) staff.

With prior arrangement and agreement with the practice partners the research nurse will make an appointment with the practice manager (PM) who will either facilitate practice staff to conduct a computer search to randomly select potential controls or supply the nurse with their own unique user name and password to do so. The search will be conducted using the practice computer system's inbuilt randomisation programme, based on a numbered list of age and gender-matched patients (approximating 2 per MPN case, calculated on the basis of an attrition rate of 40-50%). The GP will be asked to confirm the eligibility of each potential control patient prior to them receiving study information from the practice.

Study information will be mailed to eligible control patients from the practice on practice headed paper and with a letter, signed by the GP, inviting them to participate. In order to track patient replies, each envelope will have a unique code number written on the front. A patient tracker form with the unique code number written beside the relevant name on the list of control patients is kept in the practice study file to track responders and non-responders for follow up purposes. No patient identifiable data will be removed from the practice at any time.

Non-respondents will be randomised to either receive a reminder letter approx two weeks after the first mail shot or to have a telephone call from practice staff using the follow-up telephone transcript.

2.8.1.2 Southampton The research nurse in Southampton will work in partnership with GP practices to provide support, guidance and facilitate research. An honorary contract and confidentiality agreement will be arranged with the practices.. This will include the nurses NMC number and copies of GCP training certificates. Practices are supplied with a study file, which is kept in a secure location at the practice and contains the study protocol and all relevant study information including the completed Research Governance form and contact details of researchers and NICRN (PC) staff.

With prior arrangement and agreement with the practice partners the research nurse will make an appointment with the practice manager (PM) who will either facilitate practice staff to conduct a computer search to randomly select potential controls or supply the nurse with their own unique user name and password to do so. The search will be conducted using the practice computer system's inbuilt randomisation programme, based on a numbered list of age and gender-matched patients (approximating 2 per MPN case, calculated on the basis of an attrition rate of 40-50%). The GP will be asked to confirm the eligibility of each potential control patient prior to them receiving study information from the practice.

Study information will be mailed to eligible control patients from the practice on practice headed paper and with a letter, signed by the GP, inviting them to participate. In order to track patient replies, each envelope will have a unique code number written on the front. A patient tracker form with the unique code number written beside the relevant name on the list of control patients is kept in the practice study file to track responders and non-responders for follow up purposes. No patient identifiable data will be removed from the practice at any time.

Non-respondents will be randomised to either receive a reminder letter approx two weeks after the first mail shot or to have a telephone call from practice staff using the follow-up telephone transcript.

2.8.2 Relative/Friend Controls Recruitment of 100 non-blood relative/friend controls will be undertaken by asking cases to pass on a flyer to up to 2 or 3 non-blood relatives/friends aged 18 years or older. Controls meeting the exclusion, section 2.7, will not be eligible for participation. Controls will not be individually matched to cases but must reside in the study area (Belfast or Southampton). Blood relatives will not be eligible for participation. Partners or friends MPN cases attending outpatient appointments in Belfast City Hospital or UHS will also be approached to participate in the study as study flyers will be available. A reminder to follow-up with recruitment of non-blood relatives/controls will be undertaken at the time of telephone interview with the cases. Those interested in participating in the study can contact the study team for the information sheet, consent form and other documentation by completing the tear off contact details strip on the flyer and posting (in the FREEPOST envelope that will be attached to the flyer) to the study team or by telephone or e-mail.

INFORMED CONSENT All cases and controls will be contacted by letter with a patient information leaflet, a consent form, patient contact form and work/residence history calendar. A pen will be included in the envelope in addition to a MPD Voice charity information sheet and a trolley token (for 50% of cases and controls). The number of subjects who refuse to participate will be documented. Subjects who refuse to participate at telephone contact will be asked whether they are willing to answer a short questionnaire to assess the representativeness of the recruited subjects. Subjects will be given the opportunity to withdraw from the study at any time however the information provided up to that point will be retained and used within the study. Subjects will be asked for verbal consent at time of telephone interview to have the interview recorded both before and after (if agreeable) the recording device is activated.

Venous blood sample (up to 12 ml) - whole blood, DNA Saliva (2ml) Dried Blood spots (500 µl) Toe-nails (2 great toe-nail clippings)

Myeloproliferative Neoplasms: an In-depth Case-control Study

Researchers can contact the study lead (Dr Anderson) to request a data access form. Once a data access form has been completed it will be reviewed by the study team and a decision made. If sharing of data has been agreed by the study team the contracts department and legal teams will review the proposed sharing of data to ensure that it meets with international standards.

* Difference in participation rates in those receiving:
* vs. not receiving a pen at initial contact.
* vs. not receiving a trolley token at initial contact.
* vs. not receiving a monetary incentive at initial contact.
* a MOSAICC pen vs. a non-branded pen following second contact.
* vs. not receiving a trolley token following second contact.
* a MOSAICC branded Pen +/or trolley token alone vs no non-monetary incentive following a second invite.
* a MOSAICC branded Pen +/or trolley token alone vs no incentive following a second invite.
* a MOSAICC branded Pen +/or trolley token alone vs pen/no pen \&/or money following a second invite (branded vs unbranded incentive)
* 0/1 of these incentives vs. receiving 2/3 incentives following a second invite.
* Difference in proportion of patients completing study elements comparing:
* 0/1 vs 2/3 incentives.
* those receiving pre vs post invitation incentives.

University Hospital Southampton NHS Foundation Trust

University of Manchester

Western Australian Institute for Medical Research

Mayo Clinic

Queen's University, Belfast

Chief Investigator

Adverse Events were not collected/assessed

Patients with Polycythemia vera (PV), essential thrombocythemia (ET) and primary myelofibrosis (PMF) will be recruited based on the WHO diagnostic criteria.

Exclusion Criteria

* younger than 18 years old.
* where the clinician/General Practitioner (GP) does not provide consent.
* incapable of giving informed consent.
* physically or cognitively incapable of completing the questionnaire.
* too ill to participate.

Methodological pens: Randomisation of branded pen, non-branded pen and no pen

Methodological compensation: Randomisation of a £10 monetary reimbursement for expenses on completion of the study

Methodological trolley tokens: Trolley tokens to be randomly assigned to half of cases and General Practice controls.

Myeloproliferative Neoplasm Case

For each MPN case one GP control will be randomly selected and frequency matched to the distribution of cases by 5-year age band, geographic location (Belfast and Southampton) and gender.

The following patient groups will be excluded. Those:

* younger than 18 years old.
* where the clinician/GP does not provide consent.
* incapable of giving informed consent.
* physically or cognitively incapable of completing the questionnaire.
* too ill to participate. The WHO performance evaluation scale will be used at the stage of participant identification. Only those scoring 0-3 will be considered eligible for inclusion in the study. Those scoring 3 are described as "Symptomatic \>50% in bed but not bedbound".

General Practice Control

Recruitment of 100 non-blood relative/friend controls will be undertaken by asking cases to pass on a flyer to up to 2 or 3 non-blood relatives/friends aged 18 years or older.

Methodological pens: Randomisation of branded pen, non-branded pen and no pen

Methodological compensation: Randomisation of a £10 monetary reimbursement for expenses on completion of the study

Non-blood Relative or Family Control

The letters inviting participants to participate in the study were randomised to contain:

* a branded pen, an unbranded pen or no pen
* a trolley token
* Information in the study information leaflet that £10 compensation cheque would be provided upon completion and details in the letter that compensation would be provided vs no mention of compensation in the information booklet or invitation letter.

The letters inviting participants to participate in the study were randomised to contain:

* a branded pen, an unbranded pen or no pen
* Information in the study information leaflet that £10 compensation cheque would be provided upon completion and details in the letter that compensation would be provided vs no mention of compensation in the information booklet or invitation letter.

Non-blood Relative Family Control

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United Kingdom

Region of Enrollment

Dr Lesley Anderson

No. of Participants who didn't receive an incentive

No. of participants who got pen - INITIAL CONTACT

No. participants got TrolleyToken- INITIAL CONTACT

No. participants got compensation -INITIAL CONTACT

No. who got Mosaicc pen- INITIAL CONTACT

No. who got Normal pen-INITIAL CONTACT

No. who got Pre-incentive (pen and/or trolley token) only- INITIAL CONTACT

No. who got compensation only- INITIAL CONTACT

No. who got pre & post incentive e.g. pen, trolley token and compensation - INITIAL CONTACT

No. of participants who got 0 or 1 incentive- INITIAL CONTACT

No of participants 2or 3 incentives(F/F controls could only receive a max of 2 incentives) - INITIAL

No who participated after the second invite

No of participants after second invite who initially received a MOSAICC pen

No of participants after second invite who initially received a Normal pen

No of participants after second invite who initially received a Trolley token

For each MPN case one GP control will be randomly selected and frequency matched to the distribution of cases by 5-year age band, geographic location (Belfast and Southampton) and gender.

The following patient groups will be excluded. Those:

* younger than 18 years old.
* where the clinician/GP does not provide consent.
* incapable of giving informed consent.
* physically or cognitively incapable of completing the questionnaire.
* too ill to participate. The WHO performance evaluation scale will be used at the stage of participant identification. Only those scoring 0-3 will be considered eligible for inclusion in the study. Those scoring 3 are described as "Symptomatic \>50% in bed but not bedbound".

Methodological pens: Randomisation of branded pen, non-branded pen and no pen

Methodological compensation: Randomisation of a £10 monetary reimbursement for expenses on completion of the study

Methodological trolley tokens: Trolley tokens to be randomly assigned to half

Influence of Pre- and Post- Incentives on Participation Rates.

Overall Study

Symptoms and General Pathology

Nervous System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Adenocarcinoma

Neoplasm Metastasis

Adenocarcinoma of Lung

Brain Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Adenocarcinoma

Yong Wang, PhD

This study aimed to detect cell free DNA (cfDNA) in the cerebrospinal fluid and plasma, and to determine whether cfDNA can be used for concomitant diagnosis to improve the treatment efficacy and prognosis of patients with brain (meningeal) metastasis by monitoring tumor-related genetic mutations in cfDNA in the plasma and cerebrospinal fluid.

This study planned to enroll 50 patients with lung cancer diagnosed with brain (meningeal) metastases, and all cases were slated to receive radiotherapy and targeted therapy. Patients' clinical data were collected (including but not limited to: age at diagnosis with brain (meningeal) metastases, KPS score, smoking history, stage of disease at diagnosis, time to progress to brain metastases, number of brain metastases, extracranial metastases (ECM), and systemic disease at the time of brain metastases. Anticoagulated whole blood and anticoagulated cerebrospinal fluid were collected before local treatment (samples of primary cancer tissue and metastatic carcinoma of some patients were preserved) and at 7 days, 1 month, 3 months, as well as 6 months after the treatment (time of sample retention was to be determined, Figure 2). DNA was extracted from tumor tissues, genomic DNA was extracted from leukocytes, and cfDNA was extracted from plasma and cerebrospinal fluid, for complete quantitative detection of DNA, DNA library construction, as well as targeted capture sequencing. Tumor-related genes were analyzed, and changes in the tumor burden during the treatment process were evaluated. The clinical significance of cfDNA in the plasma and cerebrospinal fluid for treatment efficacy and prognosis was evaluated, and compared with that of clinical indicators of treatment efficacy.

This study involved two stages. The first stage was a pre-experiment: samples were retained from 3-5 cases, and mutations in tumor-related genes in the cfDNA in plasma and cerebrospinal fluid were compared. The investigators analyzed, combined with clinical indicators, whether mutations of cfDNA in plasma accord with that of the cerebrospinal fluid and whether mutations of cfDNA in cerebrospinal can reflect the mutational status of tumor cells. The second phase was conducted by expanding the number of cases, based on the first stage.

Anticoagulated whole blood, anticoagulated cerebrospinal fluid and tumor tissue were collected. DNA was extracted from tumor tissues, genomic DNA was extracted from leukocytes, and cfDNA was extracted from plasma and cerebrospinal fluid.

Detection of CSF Next Generation Sequencing in the Application of Brain Metastases From Lung Adenocarcinoma or Meningeal Metastasis

Investigate whether the cfDNA can be used for concomitant diagnosis to improve the treatment efficacy and prognosis of patients with brain (meningeal) metastasis by monitoring tumor-related genetic mutations in cfDNA in the plasma and cerebrospinal fluid.

Shandong Cancer Hospital and Institute

Lung Diseases

Respiratory Tract Diseases

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.

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

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

Research readiness tool

Catherine L Henshall, PhD

Iain Williamson, PhD

Zoe Davey

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.

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.

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. These will explain the purpose of the study and provide details of what is involved. The letter will include the contact details of the research team and nurse participants will be asked to contact them if they are interested in taking part. A member of the research team will then offer to speak to the participants if they have any further questions about the study. If they are still happy to proceed the 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, who will provide access to an online link where potential participants can access information about the study (PIS and invitation letter) and can sign up via an online consent platform. Once consented the research team will contact them about the study and confirm they are happy to take part.

Patients and carers will be eligible to take part if they meet the following eligibility criteria:

Patients and carers will be recruited through the NCRI consumer forum and other cancer patient/carer networks, including RCLCF and Mesothelioma UK, who will provide access to an online link where potential participants can access information about the study (PIS and invitation letter) and can sign up via an online consent platform. Once consented the research team will contact them about the study and confirm they are happy to take part. LCNs at participating NHS sites will share invitation letters and information leaflets with LCPs, inviting them to take part. These will explain the purpose of the study and provide details of what is involved. The letter will include the contact details of the research team and nurse participants will be asked to contact them if they are interested in taking part. A member of the research team will then offer to speak to the participants if they have any further questions about the study. If they are still 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. 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. Team members are affiliated with participating NHS sites and will utilise local contacts to facilitate recruitment. A topic guide will explore issues around LC trials awareness, knowledge of referral processes, confidence discussing trials, communication networks, time issues and factors influencing trial entry. Focus groups will be held virtually via Microsoft Teams. Participants will provide online consent and demographic information. 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 \[20\].

Phase 3: Phase 1\&2 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, Derby\&Burton, Lanarkshire, Nottinghamshire. An additional two NHS sites, Surrey and Birmingham, will act as controls.

Each site's LCNs (n=36) 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). This will explain the purpose of the study and provide details of what is involved. The letter will include the contact details of the research team and nurse participants will be asked to contact them if they are interested in taking part. A member of the research team will then offer to speak to the participants if they have any further questions about the study. If they are still happy to proceed the researcher will organise a time, date and place with participants to proceed with 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 (n=24) 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 (n=36) at baseline, three and six months and LCN's 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 1\&2 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 (n\~36). 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 to explore the tool's acceptability, in terms of ease of use and impact on recruitment. We intend to invite between 1-2 nurses from each site to take part in the interview and they will be convenience sampled. Eight patients/carers who have joined clinical trials at the pilot sites will also be interviewed.

Patients and carers will be recruited through the LCNs and RCLCF and Mesothelioma UK networks, who will facilitate contact with local LCP support groups. LCP and carers 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 tool's impact on LCP experience.

Ethics: NHS HRA ethics will be obtained, as well as local R\&D approvals from each of the participating NHS Trust sites prior to recruitment commencing at these sites. Participants will be given detailed information sheets covering all relevant aspects of their involvement in the project, including confidentiality and GDPR. All participants will be asked to sign a consent form. Project team members and facilitators all understand the principles of safeguarding. Specifically, they will: understand they have a duty of care for and a responsibility to protect the health, wellbeing and human rights of participants; recognise participants may be at increased risk of distress due to the nature of the study; understand how to offer practical and emotional support; know how to signpost to any relevant support services.

Reporting and Future Research Ideas and recommendations generated through a discussion of the findings will be used to inform best practice and to implement clinical standards across the NHS. They will be reported in peer-reviewed publications and presented at conferences. A summary report of findings will be published on the University's website, as well as on the Roy Castle Lung Cancer Foundation website to ensure availability to patients and the public. In addition, findings will be promoted and disseminated through our partners Lung Cancer Nursing UK, Mesothelioma UK, Scottish Lung Cancer Nursing Forum, National Cancer Research Institute and British Thoracic Oncology Group, as well as via social media channels.

Following completion of the project, the project team will review the potential for the research readiness tool that has been developed to be implemented and evaluated across a larger number of NHS sites, with recommendations for the tool's use being generated, to inform policy and practice in this area.

Timelines: The timeline for the project is 24 months, including the time taken to obtain relevant permissions and approvals prior to the commencement of the interview study. It is anticipated that survey, focus group and interview recruitment, data collection and analysis will take be carried out from Oct 2023 to March 2025, and the reporting and dissemination will take place from April to June 2025. Four six monthly steering group meetings are planned throughout the study duration.

Improving Access to Lung Cancer Clinical Trials

Improving Access and Recruitment to Clinical Trials for Lung Cancer Patients

Individual participant data will not be shared woith researchers outside of the study team. Hwever, deidentified data will be shared through publications and reports and other dissemination activities.

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

Data willl be collected on number of times nurses have discussed trials opportuniites with patients

De Montfort University

Oxford Brookes University

Reader in Nursing

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.

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.

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

Monica Hugh

Adam Januszewsk

Bing Smith

Sarah Sarker

Jackie Fenemore

June Morley

Najib Rahman

Agnieszka Kehinde

Andrea Sorsby

John McPhelim

Catherine Henshall, PhD

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.

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.

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 patient/carer 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 1\&2 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, Derby\&Burton, Lanarkshire, Nottinghamshire. An additional two NHS sites, Surrey and Birmingham, will act as controls.

Each site's LCNs (n=36) 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 (n=24) 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 (n=36) at baseline, three and six months and LCN's 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 1\&2 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 (n\~36).

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 tool's acceptability, in terms of ease of use and impact on recruitment.

Eight patients/carers 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 tool's impact on LCP experience.

IPD will not be shared with researchers outside of the study team.

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.

Data will be collected from each LCN (n=36) at baseline, three and six months on the number of lung cancer patients each lung cancer nurse has approached to discuss clinical trial opportunities

Data will be collected from each lung cancer nurse (n=36) at baseline, three and six months on their knowledge of clinical trials. Data will be collected via a non-validated Likert style survey with five options ranging from 'strongly agree' to 'strongly disagree'.

Data will be collected from each lung cancer nurse (n=36) at baseline, three and six months on their confidence in talking to lung cancer patients about clinical trials. Data will be collected via a non-validated Likert style survey with five options ranging from 'strongly agree' to 'strongly disagree'.

Data will be collected from each lung cancer nurse (n=36) at baseline, three and six months on their awareness of lung cancer clinical trials opportunities. Data will be collected via a non-validated Likert style survey with five options ranging from 'strongly agree' to 'strongly disagree'.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Myeloproliferative Neoplasms: an In-depth Case-control Study	NCT01831635	Polycythemia Ve... Essential Throm... Primary Myelofi...	Methodological ... Methodological ... Methodological ...	18 Years -	Queen's University, Belfast
Detection of CSF Next Generation Sequencing in the Application of Brain Metastases From Lung Adenocarcinoma or Meningeal Metastasis	NCT03029065	Recruitment		18 Years -	Shandong Cancer Hospital and Institute
Improving Access to Lung Cancer Clinical Trials	NCT05780164	Lung Cancer Patient Engagem... Research, Commu... Nurse-Patient R... Recruitment	Research readin...	18 Years - 65 Years	Oxford Brookes University
Improving Access to Lung Cancer Clinical Trials	NCT05780164	Lung Cancer Patient Engagem... Research, Commu... Nurse-Patient R... Recruitment	Research readin...	18 Years - 65 Years	Oxford Brookes University
Myeloproliferative Neoplasms: an In-depth Case-control Study	NCT01831635	Polycythemia Ve... Essential Throm... Primary Myelofi...	Methodological ... Methodological ... Methodological ...	18 Years -	Queen's University, Belfast
Improving Access and Recruitment to Clinical Trials for Lung Cancer Patients	NCT05888584	Lung Cancer	Research readin...	18 Years -	Oxford Brookes University

Spots Global Cancer Trial Database for recruitment

Every month we try and update this database with for recruitment cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for recruitment

Every month we try and update this database with for recruitment cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for recruitment cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.