Intervention:

Behavioural:

Questionnaires for patient/family caregiver interview

BIDHU K MOHANTI, MD

Jaspreet Kaur, MD

Bidhu K MOHANTI, MD

Jaspreet KAUR, MD

Sudhir K Khandelwal, MD

Ravindra M Pandey, PhD

The purpose of this study is to assess the various aspects of life in the cancer survivors in India. Cancer survivor is defined as "an individual diagnosed with cancer and who has survived the disease and treatment, and for the rest of his/her life".

Cancer survivors are at increased risk of developing various physical and psychosocial conditions, which require to be identified and attended within the cancer care system.

Survivorship research is seen as addressing the medical, functional, and health related issues of individuals diagnosed with cancer, as well as that of their families.

It is estimated that approximately 25 million people are living as cancer survivors worldwide. The cancer survivors are those individuals who live beyond a cancer diagnosis and its therapy. Within the existing health care system, the cancer care models are largely focused on diagnostic methods, treatment aspects, cure, and disease failure and survival rates. There is very little research and intervention approaches for the after-effects of cancer diagnosis and treatments for an individual cancer patient. Cancer survivors are at increased risk of developing various physical and psychosocial conditions, which require to be identified and attended within the cancer care system. In the developing countries like India, the cancer cure rates are improving due to improvements in comprehensive diagnostic and treatment strategies. Cancer survivorship research will be valuable to enhance our understanding and care approaches to these vulnerable individuals in our society. There is lack of evaluation tools which can completely fit to assess all issues such as physical, social, financial, mental aspects of a cancer survivor.

Hence the investigators of this observational study have prepared an empirical cancer survivorship questionnaire (CSQ) which will document the patient's disease and treatment details and obtain subjective responses from the patient(and/or family care giver) related to the physical, functional, social, economic and mental aspects of daily living of a cancer survivor. In order to assess the mental status of the survivors, the investigators have also included the widely used and internationally accepted MINI (Mini-international neuropsychiatry interview) version along with the CSQ in this survey. Researchers and clinicians working in non-profit and academic setting such as this institution are allowed to make copies of this MINI questionnaire for the purpose of clinical and research use. For the present study, MINI version is suitably modified to exclude the items which are already in the CSQ, and certain items are reframed for the socio-cultural requirement. Both the CSQ (45 items) and MINI-modified (13 items) will be applied simultaneously in this survey as a direct face to face response documentation from the patient (cancer survivor), along with his/her family member. Patients will be chosen for this cross-sectional survey during the follow-up visit to a cancer clinic of this hospital, at least 3 months after the completion of cancer diagnosis and therapy. Each participant is expected to complete the survey at the first encounter, however, a provision is made to report any missing information at later visit.

An interim analysis will be carried out after the survey of first 50 patients to observe the trends in the findings. However, this will not impact the further accrual, except for making some changes in the survey parameters if at all needed.

Cancer Survivorship Issues: A Survey of Patients in India.AIIMS Study (CANSURVIVE)

Behavioral: Questionnaires and medical records. The cancer survivors' physical, social, economic and psychological issues will be assessed as verbal response.The survey questionnaires will document the sequelae of cancer and its treatment during the face to face interview and by collecting information from the individual cancer survivor's medical records

Behavioral:MINI-international neuro-psychiatric questionnaire(modified for local use)

This cancer survivorship survey will include adult cancer survivors post-therapy. Survivors of various neoplasms will be accrued for this survey.

This survey of 200 adult cancer survivors will analyse various issues-physical, social, psychological and economic which adversely impact the life of cancer survivors in India.

This analysis will help in evolving a feasible approach towards implementation of follow up care practice for cancer survivors.

All India Institute of Medical Sciences, New Delhi

Professor Department of Radiation Oncology

patient information leaflet

Susan J Palmer

The purpose of this study is to investigate the feasibility of carrying out a full scale randomised controlled trial to compare the effects of giving additional information versus no additional information to patients prior to their first oncology appointment.

Hypothesis: Patients with some awareness of research provided prior to clinic appointment in oncology and aware of the possibility of being invited to take part in a clinical trial are more likely to agree to participate.

The recruitment of cancer patients into clinical trials may be hindered by several factors such as limited understanding of medical research, a lack of information about the type of research on offer for patients, over load of information when given a new and life limiting diagnosis. Nor does the Churchill Hospital inform patients that research is an integral part of the every day life and business of the hospital.

Does increasing research awareness impact on accrual?

This initial study aims to establish the feasibility of a larger study to gather the evidence required to investigate whether patients need some information indicating that a hospital participates in research, and what it may mean to the individuals to participate, including new terminology; thus reducing fear and anxiety and ultimately increasing the accrual of cancer patients into cancer clinical trials. Prior knowledge of patients' attitudes to involvement in clinical trials might assist communication about trials and encourage more doctors to approach eligible patients. In the NHS there is always a fear of cost implications, however a study comparing two New Patient Information Packs (NPIPs) showed no differences were detected between a full pack and a mini pack and given the cost, the mini-New Patient Information Pack (mini-NPIP) was the preferred approach. This has influenced the decision to provide only a brief leaflet of information to patients prior to their first appointment.

The National Cancer Research Network (NCRN) was formed three years ago with the aim to provide the NHS infrastructure to support and improve patient care by speeding up access to the best treatment and care, provide information and support to our patients and improve the speed of research by increasing the number of patients into clinical trials. In the Thames Valley Cancer Research Network (TVCRN) accrual has increased from 2.7% in 2001-2 to 8.3% in 2003-4. The infrastructure to support research is in place, clinicians are informed and have relevant nursing and administrative support to offer trials to patients and cope with the increased numbers of patients taking part. There appears to be a deficit in the research knowledge and understanding of the general public. It is easier and less stressful to 'opt out' when faced with a new diagnosis and complicated treatment options than to consider, in addition, a clinical trial. By measuring accrual and evaluating the patients' response to information about research I intend to investigate the feasibility of a larger study to provide the evidence to investigate the need for pre-first-visit research information. Thus investigating the requirement, importance and need for information for the patients before their first oncology appointment and the general public.

Ellis, Buttow and Tattersall have published two studies conducted with breast cancer patients: the first in 2001 found that that women who have a better knowledge of clinical trials are more willing to consider participating in a clinical trial, however in 2002 patients who had received a booklet of information about research for patients were significantly less likely to consider participating in a randomised clinical trial (RCT). Using a very large sample (n=2331) Jenkins, Fallowfield and Saul showed that the vast majority of cancer patients questioned wanted a great deal of specific information concerning their illness and treatment.

RAW Study Version 3.4

Does Increasing Research Awareness Impact on Accrual? A Feasibility Study. Protocol Version 3.4 Dated April 2005.

Liverpool John Moores University

National Cancer Research Network

Oxford University Hospitals NHS Trust

Symptoms and General Pathology

All Conditions

Recurrence

Antineoplastic Agents

All Drugs and Chemicals

Topotecan

Topoisomerase I Inhibitors

Enzyme Inhibitors

All subjects received Topotecan, administered intravenously over 30 minutes at 4 milligrams per meter\^2 weekly for 3 weeks every 28 days.

topotecan

GSK Clinical Trials

A multi-center, open label, single dose Phase I pharmacokinetic (PK) characterization of weekly IV (intravenous) topotecan given at 4mg/m2. 15 patients will be evaluated.

Topotecan Pharmacokinetic Characterization Study

A Phase I Study to Characterize the Pharmacokinetics of 4 mg/m2 Weekly Intravenous Topotecan in Patients With Cancer

GlaxoSmithKline

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Hematologic Diseases

Precancerous Conditions

Blood is collected in order to perform in vitro research:

1. If a routine blood test is performed for clinical tests, the sponsor will receive the results of the Complete blood count (CBC) and an additional blood sample from the same puncture of 20ml to maximum 40ml will be collected for this study.
2. If no routine blood test is performed for clinical tests, a CBC will be performed for the study and an additional blood sample of 20ml to maximum 40ml will be collected.

Additional Bone marrow (BM) material will be obtained from the same puncture performed for routine clinical tests:

Blood test

Lea Bensoussan, MSc

Natalie Yivgi Ohana, PhD

Yishai Ofran, MD

Chani Waldenberg

The study Objective is to collect samples of bone marrow aspirates and peripheral blood of patients with MDS for use in non-clinical research to investigate mitochondrial function sequence and effect of mitochondrial augmentation.

Mitochondrial dysfunction is often associated with MDS. Studies have shown mitochondrial DNA (mtDNA) mutations in different MDS subtypes; however, their role in the pathogenesis and disease progression are not yet clear. Point mutations were found in various locations in the mitochondrial genome including tRNAs, rRNAs, and mitochondrial proteins.

Mitochondrial fragmentation in hematopoietic stem and progenitor cells (HSPC) can lead to ineffective hematopoiesis in MDS, suggesting mitochondria as a therapeutic target for treating MDS.

Mitochondria augmentation therapy (MAT) is a novel cell technology where hematopoietic stem and progenitor cells (HSPCs) are augmented ex vivo with mitochondria obtained from donor cells or tissue. MAT is based on the demonstrated ability of isolated mitochondria to enter cells and impact mitochondrial function and metabolic activity in the recipient cells. The transfer of mitochondria from cell to cell has been demonstrated using extracellular vesicles, nanotubes, and micropinocytosis. Mitochondria entering cells provide copies of normal mtDNA, which can be further propagated via replication within the recipient cell and via intercellular transfer.

Research will include in vitro and in vivo studies with the bone marrow sample, including, among other, the following: mitochondrial augmentation of bone marrow aspiration and/or subpopulations of cells (e.g. CD34+) isolated from the bone marrow aspiration; differentiation of augmented and/or non-augmented bone marrow aspiration and/or subpopulations of cells into hematopoietic lineages (e.g. erythroid, megakaryocyte, etc); assays of mitochondrial content and function; assays of hematopoietic lineages; culture of augmented and/or non-augmented bone marrow aspiration and/or subpopulations; cryopreservation of augmented and/or non-augmented bone marrow aspiration and/or subpopulations; sequencing of mitochondrial DNA and nuclear DNA; in vivo studies of engraftment, biodistribution and function of augmented and/or non-augmented bone marrow aspiration and/or subpopulations of cells isolated from the bone marrow aspiration.

Research will include in vitro studies with the peripheral blood sample, including, among other, the following: immunophenotyping of peripheral blood cells and immune-related functional assays; mitochondrial content and function of peripheral blood cells.

Collection of Samples of Bone Marrow Aspiration From Patients With Myelodysplastic Syndrome

assays of mitochondrial content and function on whole bone marrow and HSPCs assays of hematopoietic lineages;

in vivo studies of engraftment, biodistribution and function of augmented and/or non-augmented bone marrow aspiration and/or subpopulations of cells isolated from the bone marrow aspiration., in vitro ability to differentiate to various hematopoeitic lineages, immunophenotyping and single cells studies of cells post-augmentation and post-differentiation

Persistence of exogenous mtDNA after in vitro or in vivo culturing

Minovia Therapeutics Ltd.

Sarcoma

Osteosarcoma

Mesenchymoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Malignant Mesenchymoma

Richard F. Schlenk, Prof.Dr.med

SarcBOP Team

Editha Gnutzmann, M.A.

Christoph E. Heilig, Dr. med.

Stefan Fröhling, Prof. Dr.

SarcBOP - An interdisciplinary and translational registry

SarcBOP aims to establish a database that integrates every aspect possibly relevant to sarcoma treatment and research. SarcBOP thus will not be limited to specific questions or patient groups, but instead will build a comprehensive database including clinical, pathologic, and radiologic information, multi-layered molecular data, and patient-reported outcomes, combined with a dedicated biobank for tissue samples and liquid biopsies. As the study integrates seamlessly with the clinical activities of the Heidelberg Sarcoma Center, the Molecular Diagnostics Program of NCT Heidelberg, including the NCT/DKTK MASTER Program, and with the NCT Trial Center, including the PMO Clinical Trials Program, SarcBOP will generate a comprehensive and continuously growing resource for clinicians, researchers, and, finally, patients.

The following data are collected and stored:

* Demographics
* Comorbidities
* Clinical characteristics at diagnosis, relapse and progression
* Radiologic images
* Histological images
* Treatments including DRG and OPS data, including detailed information on surgical, radiation, and medical therapy as well as treatment relevant follow-up data
* Longitudinal disease assessments
* Clinical outcome
* Genomic, transcriptomic, epigenomic and proteomic data
* Patient reported outcomes

Furthermore, biological samples are collected and processed by the Sample Processing Laboratory of the Heidelberg Center for Personalized Oncology and the NCT Biobank.

The Sarcoma Biology and Outcome Project

A Prospective Registry Study on Biological Disease Profile, Intervention Type and Clinical Outcome in Adolescent and Adult Patients With Soft-tissue and Bone Sarcoma

Standardized Quality of Life Assessment, Higher values are better

Standardized Quality of Fatigue, Higher values are worse

Standardized Quality of anxiety and depression, Higher values are worse

Standardized Quality of cognitive function, Higher values are better

Disability of the arm, shoulder and hand, lower values are better

European foot and ankle society, higher values are better

Oxford knee score function and pain questionnaire after total knee replacement surgery, (TKR), higher values are better

Musculoskeletal tumor society score, higher values are better

Oswestry back pain disability questionnaire after spinal surgery, lower values are better

Oxford hip score - Function and pain questionnaire after hip replacement surgery, higher values are better

Pittsburgh Sleep Quality Index, Higher values are worse

The length of time from the date of diagnosis disease, that patients diagnosed with are still alive

The length of time from the date of diagnosis disease, that patients diagnosed

length of time during and after treatment, that a Patient lives with the disease without getting worse

Prof. Dr. Richard F Schlenk

Head of NCT trials center and Clinical Trials

Our study will be largely advertised to DCC's patients and caregivers via electronic provider portal BPA. Providers will provide prospective participants with a link to an online survey where they can consent, complete eligibility screening, the pretest, and contact information.

People with social medial accounts (e.g. Facebook) will receive a message about the study (e.g. via a geospatially targeted Facebook ad) and have the option to enroll in the study if meeting eligibility criteria, with some participating in online follow-up.

Participants will receive education via an electronic portal covering the key messages pertaining to cancer research studies and clinical trials. Data will be collected via pre- and post-tests. The post-test includes questions to pre-screen participants for eligibility into cancer research studies and clinical trials; as appropriate, study participants will be referred to those study/trial/clinical teams for follow-up.

Electronic portal education

Participants will receive online education via a video and written web content. Key messages will include information pertaining to cancer research studies and clinical trials. Data will be collected via pre- and post-tests. The post-test includes questions to pre-screen participants for eligibility into cancer research studies and clinical trials; as appropriate, study participants will be referred to those study/trial/clinical teams for follow-up.

Online educational video

Judith R Rees, BM, BCh, MPH, PhD

This study investigates different ways to educate rural residents living in New Hampshire and Vermont about cancer research studies and clinical trials to increase knowledge of, increase positive attitudes toward, and encourage enrollment in cancer research studies and clinical trials. The information learned from this study will contribute to a nation-wide initiative to educate the public about clinical trials, including a nation-wide evaluation of that initiative. The results of this study may also help researchers understand how education about clinical trials/research affects knowledge of and attitudes toward cancer research and clinical trials, as well as behavioral intentions and actual behaviors related to enrolling in cancer research studies and clinical trials.

The study team will implement and evaluate the research study and clinical trials education in two experimental arms-

1. electronic portal education about clinical trials and cancer research (Aim 1a)
2. online education via an online video about clinical trials and cancer research (Aim 1b)

The education in both formats will be based on a set of key messages that cover information about research studies and clinical trials, including what research studies are, the benefits, the risks, and connection to available research studies and clinical trials

Experimental Arm 1 (Aim 1a):

Implement electronic portal education regarding what clinical trials and cancer research are and evaluate the effect on knowledge of, attitudes and behavioral intentions toward, and actual enrollment into clinical trials and cancer research studies.

We will evaluate educational outputs from electronic portal regarding what clinical trials and cancer research studies are. The educational content for videos was developed with the National Cancer Institute (NCI) toolkit as a foundation, with additional content added to adapt to our local institution, culture, and patient needs. The videos learning objectives focus on improving participants' knowledge about what clinical trials and cancer research studies are and how to access trials and studies, increase positive attitudes toward participating in trials and studies, and increase their intent to enroll in trials and studies.

Providers will receive a BPA indicating patient may qualify to participate in the education survey. See enclosed invitation language. Providers will also have the option to include After Visit Summary (AVS) to Patient Notes that will contain invitation link. Patients will receive a link to the survey. If they choose to take part in the study, they will do so by completing the online consent, eligibility screening, pre-test, and contact information before the class they are registered for; attend the class; and complete the post-test after the class to assess achievement of the learning objectives. They will also be asked a series of questions to assess their eligibility for existing DCC clinical trials and research studies.

Experimental Arm 2 (Aim 1b):

Implement online education regarding what clinical trials and cancer research are and evaluate the effect on knowledge of, attitudes and behavioral intentions toward, and actual enrollment into clinical trials and cancer research studies.

Participants will watch a video and view website materials ('online module') developed by DCC using messaging provided by the National Cancer Institute (NCI) and tailored to our local context. The online module's learning objectives will focus on improving participants' knowledge about what clinical trials and cancer research studies are and how to access trials and studies, increase positive attitudes toward participating in trials and studies, and increase their intent to enroll in trials and studies. Eligible participants will complete pre- and post- surveys to assess achievement of the learning objectives, and they will also be asked a series of questions to assess their eligibility for existing DCC clinical trials and research studies (see enclosed questions).

Education About Health and Cancer Study

A pre-test and post-test knowledge questionnaire conducted with participants to assess any changes in knowledge related to key learning outcomes expected from the educational intervention (assessed via percent of correct and incorrect responses to 19 true/false questions and 6 multiple choice questions).

A pre-test and post-test questionnaire conducted with participants to assess any changes in attitudes and behavioral intentions related to clinical trial enrollment (assessed via 4 Likert-scale questions)

Actual enrollment into a clinical trial or cancer research study will be assessed via Dartmouth Cancer Center (DCC) Office of Clinical Research enrollment records over 6 months post-intervention. Enrollment records for specified DCC trials/research studies will also be assessed, and change in enrollment status in cancer research or clinical trials will be measured by direct participant's active status in cancer research or clinical trials project participation.

National Cancer Institute (NCI)

Dartmouth College

Dartmouth-Hitchcock Medical Center

Associate Professor of Epidemiology; Associate Professor of Community and Family Medicine; Associate Director for Community Outreach and Engagement

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

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.

Research readiness tool

Catherine L Henshall, PhD

Iain Williamson, PhD

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.

Improving Access and Recruitment to Clinical Trials for Lung Cancer Patients

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
Cancer Survivorship Issues: A Survey of Patients in India.AIIMS Study (CANSURVIVE)	NCT01304199	Cancer		18 Years - 75 Years	All India Institute of Medical Sciences, New Delhi
RAW Study Version 3.4	NCT00280722	Cancer	patient informa...	18 Years -	Oxford University Hospitals NHS Trust
Topotecan Pharmacokinetic Characterization Study	NCT00361803	Cancer	topotecan	18 Years -	GlaxoSmithKline
RAW Study Version 3.4	NCT00280722	Cancer	patient informa...	18 Years -	Oxford University Hospitals NHS Trust
Collection of Samples of Bone Marrow Aspiration From Patients With Myelodysplastic Syndrome	NCT06144515	Myelodysplastic...	Blood test	18 Years -	Minovia Therapeutics Ltd.
Topotecan Pharmacokinetic Characterization Study	NCT00361803	Cancer	topotecan	18 Years -	GlaxoSmithKline
RAW Study Version 3.4	NCT00280722	Cancer	patient informa...	18 Years -	Oxford University Hospitals NHS Trust
The Sarcoma Biology and Outcome Project	NCT04758325	Sarcoma Malignant Mesen... Sarcoma of Bone...		12 Years -	University Hospital Heidelberg
Education About Health and Cancer Study	NCT04409782	Cancer	Electronic port... Online educatio...	18 Years -	Dartmouth-Hitchcock Medical Center
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 research

Every month we try and update this database with for research 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 research

Every month we try and update this database with for research 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 research 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.