Neoplasms

Nervous System Diseases

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Myasthenia Gravis

Syndrome

Paraneoplastic Syndromes

Paraneoplastic Syndromes, Nervous System

Nervous System Neoplasms

Autoimmune Diseases

Autoimmune Diseases of the Nervous System

Neurodegenerative Diseases

Neuromuscular Junction Diseases

Neuromuscular Diseases

Mark JW Larkin, PhD

Vitaccess Real MG (VRMG) is a patient registry designed to capture longitudinal observational data on myasthenia gravis (MG), its treatment, and impact on symptoms, daily activities, and quality of life (QoL). The duration of the registry is 10 years from launch, and approximately 600 patients will be recruited in the US and Europe with no defined upper limit. The registry will link relevant patient- and healthcare professional (HCP)-reported data with clinical data from medical records.

Patients will be recruited at clinical sites in all participating countries. In the US only, patients can additionally be recruited via community neurologists or direct-to-patient recruitment.

Traditional site recruitment (all countries):

Adult patients who are being treated for MG at one of the participating clinics or centers in one of the participating countries (the US, UK, Germany, France, or Italy) at the time of enrolment and who meet the inclusion and exclusion criteria will be identified and approached by their clinical team and invited to participate in the registry.

Patient-reported data will be collected via the VRMG Registry platform, a digital data capture platform accessible via smartphone or tablet (from the Apple or Android app store) or via PC. Custom survey and patient-reported outcomes data will be collected at baseline and at regular intervals thereafter for a follow-up period of up to 10 years. The data collected will capture the impact of MG on daily living, fatigue, and health-related quality of life.

Site research teams will complete and update an eCRF (every six months ± one months) for each patient, including data from the patient's EMR. eCRFs that are completed within one months prior to or following each six-month mark will be considered within the same assessment window for analytics purposes so that patients will not be required to visit the clinical site for the purposes of the registry outside of their regular clinical visits.

Community neurologist recruitment (US only):

Community neurologists who are treating MG patients who would be eligible for participation in the registry will be able to register their interest for involvement and provide details of their credentials via an informational website. Approved community neurologists will identify and approach potential participants, who will participate in the registry as normal. Vitaccess will partner with a third-party organization with EMR aggregator capabilities to capture data from participants' existing medical records to match eCRF outputs.

Direct-to-patient recruitment (US only):

A cohort of US-based participants in the MyRealWorld MG study - a longitudinal observational study in MG that Vitaccess has run since 2019 - have provided consent to be contacted by Vitaccess about future research. Vitaccess will contact this patient cohort directly via email to introduce them to the registry; patients can access the registry's informational website to get further information. Patients will participate in the registry as normal. Vitaccess will partner with a third-party organization with EMR aggregator capabilities to capture data from participants' existing medical records to match eCRF outputs.

Patient-reported and eCRF data will be linked via a unique ID and PIN assigned to each participant at enrolment.

Vitaccess Real MG Registry

Vitaccess Real MG Registry: A Prospective International Observational Patient Registry in Myasthenia Gravis Linking Clinical and Patient-reported Data.

A patient registry designed to capture longitudinal observational data on myasthenia gravis (MG), its treatment, and impact on symptoms, daily activities, and quality of life.

EMR data reported by HCPs or captured via EMR aggregators ("Registration Form")

EMR data reported by HCPs or captured via EMR aggregators ("Clinical Trial Participation Form")

EMR data reported by HCPs or captured via EMR aggregators ("Diagnosis Information Form")

EMR data reported by HCPs or captured via EMR aggregators ("Clinical Characteristics Form")

EMR data reported by HCPs or captured via EMR aggregators ("Medical History Form")

EMR data reported by HCPs or captured via EMR aggregators ("Concomitant Medication Log")

EMR data reported by HCPs or captured via EMR aggregators ("Routine MG Treatments Log")

EMR data reported by HCPs or captured via EMR aggregators ("Rescue MG Treatments Log")

Myasthenia Gravis Activities of Daily Living (MG-ADL) data reported by HCPs or captured via EMR aggregators ("MG-ADL")

EMR data reported by HCPs or captured via EMR aggregators ("Healthcare Resource Use")

EMR data reported by HCPs or captured via EMR aggregators ("Adverse Events")

Myasthenia Gravis Activities of Daily Living (MG-ADL) data reported by patients via the Vitaccess Real MG Registry platform ("MG-ADL")

MG Symptoms PRO Fatigue Component data reported by patients via the Vitaccess Real MG Registry platform ("MG Symptoms PRO Fatigue Component")

NeuroQoL Fatigue Short Form data reported by patients via the Vitaccess Real MG Registry platform ("NeuroQoL Fatigue Short Form")

Myasthenia Gravis Quality of Life 15-item revised scale (MG-QoL-15r) data reported by patients via the Vitaccess Real MG Registry platform ("MG-QoL-15r")

Vitaccess Ltd

Wounds and Injuries

Behaviors and Mental Disorders

Radiation Injuries

Quality of Life

Participants in this study will receive hyperbaric oxygen treatment (HBOT) but the investigators do not assign this specific intervention to the study participants. Thus, the patients in this study will receive HBOT as part of routine medical care. Consequently, we regard this as an observational study because the patients will get HBOT independently of the study and they are NOT assigned prospectively to HBOT according to a protocol to evaluate the effects.

HBOT for pelvic radiation injury typically involves a treatment pressure of 2.4 ATA (Atmospheres Absolute) breathing oxygen for 90 minutes. The treatment is delivered as series treatment, usually daily treatment up to 30 dives.

Hyperbaric oxygen treatment

May Aa Hauken, Professor

Osteoradionecrosis, dermal soft tissue necrosis, radiation cystitis, proctitis and sexual dysfunctions are well-known late-effects after radiation for cancer in the pelvic area, negatively affecting the survivors' quality of life (QOL) and psychosocial wellbeing. Increasing evidence and clinical practice support the use of hyperbaric oxygen treatment (HBOT) as an effective treatment in a variety of radiation injuries, but this is still a field with limited research and knowledge. Especially, there is a knowledge gap on how late radiation tissue injury (LRTI) influences cancer survivors' QOL and psychosocial health in a longitudinal perspective (before, along and after HBOT), as well as the patients' knowledge, expectation and experience from this treatment. This study aims to improve knowledge on these issues.

Late effects following radiation of pelvic cancers:

Annually, more than 32000 Norwegians are diagnosed with cancer where approximately 70% will be alive 5 years after diagnosis. About 50% of all cancer patients receive radiation as part of their multimodal cancer treatment, and 50% of these will be long-term survivors. Irradiation therapy is an essential part of the curative treatment of pelvic malignancies, including rectal, uterine and cervical carcinoma. Although precautions and advances are taken, radiation may affect surrounding healthy tissue and lead to acute or chronic radiation injury. About 5-15% of the patients experience late radiation tissue injury (LRTI) that develops months or years after radiation, characterized by poor microcirculation with hypoxia, tissue damage and fibrosis. Consequently, frequent late-effects are related to radiation cystitis, proctitis and enteritis, soft tissue necrosis (skin and vagina) and fistulas with increased frequency, urgency and leakage of urine or faces, diarrhoea and pain. Although these late- effects obviously interfere significantly with the survivors' quality of life (QOL) and psychosocial health, research regarding these consequences is extremely limited.

Hyperbaric oxygen treatment (HBOT) for pelvic LRTI:

HBOT is a treatment modality where the patient is placed in a pressure chamber breathing 100% oxygen while exposed to elevated ambient pressure. HBOT for pelvic LRTI typically involves a treatment pressure of 2.4 ATA Atmospheres Absolute) while breathing oxygen once daily for about 90 minutes for 6 weeks (about 30 'dives' in total). HBOT for LRTI is based upon its ability to increase tissue oxygenation, stimulate neoangiogenesis and cellular regeneration and thereby induce revitalizing and healing of damaged tissue. Although HBOT is a time- consuming treatment, it is well accepted and tolerated by the patients, with few and usually harmless side effects.

Previous studies on the effect of HBOT to reduce pelvic LRTI have not yet yielded broadly accepted and conclusive results. The available studies indicate that HBOT has a positive effect on a variety of conditions, although some studies report no effect. A Cochrane review concludes that HBOT may improve outcomes in various kinds of cancer related radiation injuries (e.g. head and neck, proctitis, osteoradionecrosis), suggesting that other tissues also are likely to respond (e.g. bladder). However, these studies operate with very heterogeneous timepoints for follow-up, varying from right after HBOT is finished to several weeks, months or years after, which may have influenced the outcomes. However, we could not find any publication stating the course of symptomatic improvement for pelvic LRTI. This knowledge-gap is a challenge when informing patients and handling their expectations for this treatment.

QOL following HBOT:

Late-effects from cancer treatment, especially pelvic LRTI, may affect all parts of cancer survivors' life. Consequently, quality of life (QOL) is reckoned as an important outcome as it comprises physiological, psychological and social aspects of well-being. However, there is an evident research gap on how pelvic LRTI influences the patients' QOL, as well as how these outcomes develop in a longitudinal perspective. Two studies show QOL improvement in patients with chronic diabetic foot ulcers after 6 weeks. One study found significant QOL improvements from perioperative HBOT in the dimensions of pain, global health and dyspnoea in 66 patients with head and neck cancers. Another study of 101 radiation-injured patients (54% head and neck, 36 % intestine and 11% bladder) showed significant one-year improvements in the QOL dimensions of vitality and physical-, role- and social function. A significantly improved healing and increased bowel-specific QOL was found immediately after HBOT and at one-year follow-up in a randomized controlled study of 120 patients with radiation proctitis. In contrast, a systematic review state that no conclusion about HBOT's influence on QOL can be made.

In summing up, different outcomes of HBOT from pelvic radiation injured cancer survivors in a longitudinal perspective are highly requested as the existing research comprises small samples, has methodological limitations and yields scant results.

The study's goals and research questions:

This study embraces three main goals: The primary goal is to improve knowledge on how QOL is affected in survivors of pelvic cancer with LRTI, and how this may change due to HBOT. The second goal is to gain information on the patients' knowledge and expectations concerning HBOT and their experiences and satisfaction with the care along the HBOT process. The third goal is to improve knowledge on the longitudinal changes in LRTI symptoms and the patients' long-term QOL after finishing HBOT. Consequently, this study addresses the following research questions:

1. How do patients experience that the LRTI symptoms influence their everyday life?
2. What perceived information, knowledge and expectations concerning HBOT do patients express before HBOT?
3. What are the patients' self-reported LRTI burden,QOL and psychosocial health before HBOT?
4. How do LRTI symptoms change during and after the HBOT course?
5. How do QOL and psychosocial health change during the HBOT course?
6. What is the correlation between LRTI symptoms and QOL during and after the HBOT process?
7. How do patients experience the HBOT process?
8. How satisfied with care are patients along the HBOT process, and which factors do they describe as important for their satisfaction?
9. What are the patients' long-term QOL, psychosocial health and LRTI burden after HBOT?

Study design:

Based on the research questions, we will perform a mixed methods study with a prospective longitudinal embedded design. Mixed method is reckoned as the third research paradigm, and in this design quantitative data are collected longitudinal (\> 3 time-points) and qualitative data are collected at two time points. This design is especially recommended where randomization is not suited or possible, and because it draws on the strengths and minimalizes the weaknesses of both quantitative and qualitative methods. Consequently, it may yield a more complete and nuanced picture of the topic, as validated questionnaires provide quantitative outcome data and in-depth interviews provide process data to explore and elaborate the quantitative results.

Recruitment and eligibility criteria: The study will recruit participants from patients that have been referred to HBOT and will undergo the treatment independently from the study. Participation in the study will neither influence whether patients are treated with HBOT, nor time or lengths or any other HBOT-related measure.

Data collection: see elsewhere

Analyses of data:

Quantitative analyses: Statistical tests will be two-tailed, with statistical significance defined as P\< .05. Descriptive statistics, correlations, paired T-tests, multiple regression analyses and longitudinal analysis with linear mixed models (LMM) (or the equvalent non-Parametric tests dependent of the characteristics of the final data set) will be used for analysis of change. Effect sizes will be calculated by Cohen's d, while Z tests will be performed to analyze differences between the sample mean and the mean in the general populations.

Qualitative analysis: Systematic text condensation (STC) will be used to analyze qualitative data. This is a descriptive and exploratory method for thematic cross-case analysis of interviews. STC is a four-step analysis that includes 1) gaining a total impression; 2) identifying units of meaning; 3) abstracting the contents of individual units of meaning; 4) summarizing their importance.

Ethics:

The Regional Committee for Medical and Health Research Ethics in northern Norway has approved the project (2018/706). The study will be conducted in line with the Helsinki Declaration, providing the participants with oral and written information and written consent. As all participants will be treated with HBOT independent of inclusion in the study, we do not anticipate any negative outcomes for study-patients.

Project management, organization and cooperation:

This study is a cooperation between Center for Crisis Psychology (CCP), Faculty of Psychology, University of Bergen and Section for Hyperbaric Medicine (SHM), Department of Occupational Medicine (DOM), at Haukeland University Hospital in Bergen, Norway. A project group, chaired by CCP's research leader, May Hauken, will run the project. As HBOT represents a narrow field internationally, the study is connected to DOM's already existing international partners in the Nordic cooperation. Additionally, a multidisciplinary and international Advisory Board will be connected to the project. User involvement will be include throughout the study and include patients, representative from the Norwegian Gynecological Cancer Organization and health care professionals working with HBOT.

Progress plan and dissemination of results:

This is a 4 year project with a specific progress plan. Based on the research questions and collected data, we plan to publish at least 8 scientific papers in international peer-reviewed journals. Results will also be disseminated via lectures, popular scientific papers, national and international conferences. At the end of the project period, we will arrange a summing -up conference.

Hyperbaric Oxygenation Treatment and Quality of Life

Pelvic Radiation Injuries After Cancer Treatment: Symptoms, Quality of Life and Experiences Before, Along and After Hyperbaric Oxygenation Treatment

We plan to make IPD available to other researchers on NSD (Norwegian Scientific Data).

Self reported quality of life scale, European Organization for Research and Treatment of Cancer (EORTC QLQ C30) scale, 30 questions, 4-point Likert scale 0-3 for 28 items, 0-6 for two items, total score 0-100 (100=highest level of functioning/ best score)

Expanded Prostate Cancer Index (EPIC) questionnaire, urinary (12 items) and bowel (14 items) subscores, 3- to 5-point Likert scale, sum-score 0-100 (0=worst symptoms)

Expanded Prostate Cancer Index (EPIC) questionnaire, urinary (12 items) and bowel (14 items) subscores, 3- to 5-point Likert scale, sum-score 0-100 (0=worst symptoms), improvement defined as a higher score of at least 0,5 standard deviations based on the study population

Total score of EORTC in-PATSAT 32 (European Organization of Research and Treatment of Cancer, In-patient satisfaction With care), 32 questions, 5-point Likert scale, total score 0-100, higher score = more satisfied with care

Haukeland University Hospital

University of Bergen

Prinsipal Investigator

All people with mental ill-health aged 18 or older who visit one of the recruitment sites will be asked to participate. Further participants will be recruited through partner organizations (non-governmental organisations, patient groups and professional organisations) involved in care for individuals with mental ill-health, as well as personal contacts. Additionally, healthcare professionals involved in care of people with mental ill-health will be asked to participate in the qualitative part of the study.

CO-CAPTAIN focuses on co-designing and piloting and evaluating the implementation of patient navigation (PN) for primary cancer prevention in people with mental ill-health. Patient Navigators, trained professionals with experience working with people with mental ill-health, will assist people with mental ill-health in gaining access to and utilizing appropriate primary cancer prevention measures offered within the respective healthcare and social system (including smoking cessation and physical activity and nutritional interventions). For this purpose, Patient Navigators will offer regular appointment with participants, apply motivational interviewing and aid in accessing appropriate materials while aiming at empowering participants in taking an active role and making better and more informed decisions regarding their health.

Patient Navigation

Igor Grabovac, MD, PhD

Hanna M. Mües, MSc

Hietzing Hospital

Medical University of Vienna

Mental Health Clinic

The Day Hospital

The Guest House / Protected apartments

POMOST

Prevention is essential for reducing cancer-related mortality. However, people with mental ill-health often face difficulties in accessing cancer prevention services. The EU-funded CO-CAPTAIN project aims to co-adapt and implement the Patient Navigation Model for primary cancer prevention in this underserved population. This evidence-based and patient-centred intervention aims to support patient empowerment through removal of systemic barriers, provide social support and promote timely access to primary prevention services.

Cancer and mental ill-health constitute leading public health problems in Europe. More than 84 million people in the European Union (EU) report living with an on-going mental ill-health condition. While issues concerning mental health are of great importance, they often overshadow physical problems that people with mental ill-health face. Such is cancer, which is more prevalent in people with mental ill-health and is also the second most common cause of death in this population. People with mental ill-health often have difficulties in accessing quality cancer prevention services, but are also additionally overlooked in research which makes them overall an underserved population. What data is available, shows that potential reasons for these higher cancer morbidity and mortality rates are linked to more engagement in risky health behaviour (especially higher prevalence of smoking as well as overweight and obesity) but also experiences of significant barriers when accessing the highly fragmented heath care systems.

Timely and evidence-based preventive strategies including optimizing health care pathways provide a solution to the high cancer morbidity and could improve overall health outcomes in this disadvantaged population. One such mixed-skill strategy is Patient Navigation. Therefore, the overall goal of the CO-CAPTAIN project is to co-adapt the Patient Navigation (PN) model focusing on primary cancer prevention and to see if this model can prove to be beneficial in supporting individuals with mental ill-health through care services to reduce cancer risk factors by increasing knowledge, health literacy and empowerment. The Patient Navigation Model is an innovative, evidence-based and patient-centred intervention, which supports patient empowerment through removal of systemic barriers, providing social support and promoting timely access to primary prevention services. Based on implementation science and utilizing the Consolidated Framework for Implementation (CFIR) as well as the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks, the CO-CAPTAIN project aims to reduce the gap in health inequalities for people with mental ill-health by reducing cancer burden and improving overall health, which will, in turn, reduce associated costs across health and social care systems in Europe. Moreover, the CO-CAPTAIN project aims to harness the transformative potential of the integrated care pathways in cancer as well as provide health and social care policy recommendations for the adoption and implementation of the Patient Navigation Model across Europe.

The adapted Patient Navigation Model will be implemented in four European countries (Austria, Greece, Poland, Spain) and its potential to enable and improve access and utilization of primary cancer prevention measures for people with mental ill-health will be evaluated. The study will employ a mixed-methods design allowing for both exploratory and confirmatory research.

The project has been funded by the HORIZON EUROPE Framework Program (Call: Research and Innovation actions supporting the implementation of the Mission on Cancer (HORIZON-MISS-2022-CANCER-01-01) - Improving and upscaling primary prevention of cancer through implementation research) and is coordinated by the Medical University of Vienna.

Cancer Prevention Among Individuals With Mental Ill-health: Patient Navigation for Primary Cancer Prevention

Cancer Prevention Among Individuals With Mental Ill-health: Co-adapting and Implementing Patient Navigation for Primary Cancer Prevention

Upon request from other researchers, the principal investigator may provide study materials and data in an anonymised and limited form, while adhering to the Data Security Department of the Medical University of Vienna.

To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in health outcomes and socio-economic risk factors in the course of study participation. Next to socio-demographic data, participants will indicate their health status, alcohol consumption, sexual risk behavior, sun exposure, and vaccination status by self-report or electronic health reports.

To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the health outcome nutritional intake. Nutritional intake will be assessed by the Rapid Prime Diet Quality Score Screener (rPDQS; range: 0-52, where higher values indicate healthier nutritional intake).

To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the health outcome smoking behavior. Smoking behavior will be assessed by the Fagerström Test for Nicotine Dependence (FND; range: 0-10, where higher values indicate higher nicotine dependence).

To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the health outcome physical activity. Physical activity will be assessed by the International Physical Activity Questionnaire (IPAQ; range: 0-19278 MET minutes per week, where higher values indicate more time spent on physical activity).

To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the health outcome depressive symptoms. Depressive symptoms will be assessed by the Patient Health Questionnaire (PHQ-9; range: 0-27, where a higher score indicates more severe depressive symptoms).

To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the health outcome generalized anxiety. Generalized anxiety will be assessed by the 7-item anxiety scale (GAD-7; range: 0-21, where higher values indicate more severe anxiety symptoms).

To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the health outcome health-related anxiety. Health-related anxiety will be assessed by items from the Whiteley Index (Whiteley-6-R; range: 0-24, where higher values indicate more health anxiety symptoms).

To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in (health-related) quality of life. (Health-related) Quality of life will be assessed by items from the World Health Organization Quality of Life Brief Version (WHO-QOL-BREF; range: 4-20, where higher values indicate higher quality of life).

To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in (health-related) quality of life. (Health-related) Quality of life will be assessed by items from the descriptive system of the EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L, where each dimension has a range from 1-5, where a higher value indicates more severe problems).

To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in (health-related) quality of life. (Health-related) Quality of life will be assessed by items from the EQ visual analogue scale of the EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L, range: 0-100, where higher values indicate better subjective health).

To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in self-efficacy. Self-efficacy will be assessed by items from the General Self-Efficacy Scale (GSES; range: 10-40, where higher values indicate higher perceived self-efficacy).

To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in feeling understood and supported by healthcare providers (HPS) as part of health literacy. HPS as part of health literacy will be assessed by items of the HPS scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-4, where higher values indicate higher perceived HPS).

To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in having sufficient information to manage one's own health as part of health literacy. Having sufficient information to manage my health (HSI) as part of health literacy will be assessed by items of the HSI scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-4, where higher values indicate higher perceived HSI).

To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in actively managing one's own health as part of health literacy. Actively managing my health (AMH) as part of health literacy will be assessed by items of the AMH scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-4, where higher values indicate higher perceived AMH).

To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in social support as part of health literacy. Social support as part of health literacy will be assessed by items of the social support of health scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-4, where higher values indicate higher perceived social support for health).

To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in appraisal of health information as part of health literacy. Appraisal of health information (CA) as part of health literacy will be assessed by items of the CA scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-4, where higher values indicate higher perceived CA).

To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the ability to actively engage with healthcare providers as part of health literacy. Ability to actively engage with healthcare providers (AE) as part of health literacy will be assessed by items of the AE scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-5, where higher values indicate higher perceived AE).

To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the ability to navigate the healthcare system as part of health literacy. Navigating the healthcare system (NHS) as part of health literacy will be assessed by items of the NHS scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-5, where higher values indicate higher perceived NHS).

To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the ability to find good health information as part of health literacy. Ability to find good health information (FHI) as part of health literacy will be assessed by items of the FHI scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-5, where higher values indicate higher perceived FHI).

To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the ability to understand health information well enough to know what to do as part of health literacy. Understanding health information well enough to know what to do as part of health literacy will be assessed by items of the Understand health information well enough to know what to do (UHI) scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-5, where higher values indicate higher perceived UHI).

To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in use of healthcare services. Use of healthcare services will be assessed by self-reports.

To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by evaluating cost-effectiveness and cost-utility. To assess cost-effectiveness and cost-utility of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, an economic evaluation will be carried out by analyzing health outcomes and costs (healthcare costs, cancer costs, burden).

To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in satisfaction with care. Satisfaction with care will be assessed by self-reports and items from the Patient Satisfaction Questionnaire Short Form (PSQ-18, range of the mean score: 1-5, where higher scores indicate higher satisfaction with medical care).

To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in discrimination experiences. Discrimination experiences will be assessed by self-reports.

The co-adapted Patient Navigation Model will be evaluated by assessing facilitators of the intervention to determine its effectiveness. Experiences of people with mental ill-health, navigators, and healthcare professionals involved in care of people with mental ill-health will be considered. Qualitative data will be gathered using semi-structured interviews.

The co-adapted Patient Navigation Model will be evaluated by assessing barriers of the intervention to determine its effectiveness. Experiences of people with mental ill-health, navigators, and healthcare professionals involved in care of people with mental ill-health will be considered. Qualitative data will be gathered using semi-structured interviews.

Senior Europa Sociedad Limitada

Prolepsis Institute for Preventive, Environmental and Occupational Medicine

Universitat Politècnica de València

STICHTING INTERNATIONAL FOUNDATION FOR INTEGRATED CARE

Medical University of Lodz

Consejería de Familia, Juventud y Política Social, Comunidad de Madrid

Servicio Madrileño de Salud, Madrid, Spain

Fundacion para la Investigacion e Innovacion Biosanitaria de Atencion Primaria

Mental Health Europe - Sante Mentale Europe

University Mental Health Research Institute, Athens, Greece

Fundacion para el Fomento en Asturias de la Investigacion Cientifica Aplicada y Tecnologia

Consejeria de Salud - Principado de Asturias

Servicio de Salud del Principado de Asturias

Project coordinator

All homeless adults, aged 18 years and over, who visit the CANCERLESS pilot sites will be asked to participate (convenience sampling). We define individuals as being homeless if they fall under one of the categories listed in the European typology of homelessness and housing exclusion.

The Health Navigator Model will be a longitudinal, person-centered and community-based intervention focused on addressing both primary and secondary cancer prevention, as well as reducing wider barriers to healthcare. Health Navigators (HNs) will be professionals who have a background in social care and an understanding of the local user population, and will be embedded in settings familiar and accessible to people experiencing homelessness. The primary aspects of the HN role will be to identify the health needs and barriers of users, promote cancer awareness and education, facilitate timely access to healthcare services and cancer screening, provide practical assistance, delivered through regular in-person meetings, and utilize wider stakeholders, including healthcare professionals, to deliver the intervention. A comprehensive training package will be delivered to the HNs, covering population specific knowledge, interpersonal skills, cancer education and local resources.

Health Navigator Model

Prevention and early detection are key for the decrease of cancer-related mortality. However, socially deprived population groups don't have the privilege of unburdened access to the healthcare system. The EU-funded CANCERLESS project aims to develop an evidence-based, patient-centred innovation that reinforces patients through health education and social support and fosters timely access to primary and secondary prevention services. Based on the combination of the tested Patient Navigator Model and the Patient Empowerment Model, CANCERLESS will develop the Health Navigator Model for Europe, addressed to the underserved population.

Homeless individuals have higher prevalence of adverse health outcomes (infectious diseases, substance-related disorders, etc.) and premature mortality compared to the general population, with cancer being the second most common cause of death. In most cases, people experiencing homelessness experience significant barriers or do not have access to community health services, including access to primary and secondary prevention services and programs. Cancer prevention and early detection among the homeless population in Europe: Co-adapting and implementing the Health Navigator Model - The CANCERLESS project is a Horizon 2020 financed project aiming to adapt a novel, evidence based and person-centered model to address this underserved population and eliminate barriers to access primary and secondary preventive services.

The Health Navigator Model (HNM), a person-centered intervention co-designed during the first part of the project, will address the growing health and social disparities in the homeless population and promote timely access to cancer prevention and screening services. Therefore, the aim of this longitudinal, person-centered, and community-based intervention study is to pilot test the HNM by investigating a cohort of individuals experiencing homelessness in pilot-sites in Austria, Greece, Spain and the United Kingdom. Our study will assess whether the HNM intervention can improve the delivery of evidence of community-based primary and secondary cancer preventive care for the homeless population. The HNM will be conducted over a set time frame, with active participation being individually tailored to the needs of participants, within an overall period of 18 months. Evaluation will be performed at baseline and at three further evaluation points to assess the outcomes of the intervention. Adult individuals experiencing homelessness (as defined by the European Topology of Homelessness and Housing Exclusion) will be asked to participate during their visits to the pilot sites of cooperating facilities (non-governmental organizations offering free medical care, or social service institutions) after assessing eligibility criteria.

The study utilizes both a qualitative and quantitative methodology which will allow us to conduct both exploratory and confirmatory research and thus, gain a deeper comprehension of the impact of the HNM intervention on overall participation of homeless individuals in primary and secondary cancer preventive programs.

The project has been funded by the HORIZON 2020 program of the European Commission under the topic: "H2020-SC1-2020-Single-Stage-RTD - Call for proposals on the prevention and/or early diagnosis of cancer" and is coordinated by the Medical University of Vienna.

Cancer Prevention and Early Detection Among the Homeless Population: The Health Navigator Model

Cancer Prevention and Early Detection Among the Homeless Population in Europe: Co-adapting and Implementing the Health Navigator Model

Anonymised and limited data set may be given to other researchers upon request from the principal investigator, following compliance of the Data Security Department of the Medical University of Vienna.

The first objective of the CANCERLESS evaluation is to determine the clinical utility/effectiveness of the Health Navigator Model intervention on the health promotion and cancer primary and secondary prevention among people experiencing homelessness. Effectiveness refers to the likelihood that a certain protocol (in this case the Health Navigator Model) will benefit users in a certain population (in this case people experiencing homelessness) by resulting in an improved health outcome. Therefore, the clinical utility/effectiveness evaluation will include the assessment of the differences between baseline and follow-up measurements, especially on health outcomes among those people experiencing homelessness that participate in the project.

In addition to the effectiveness evaluation, CANCERLESS aims to determine the cost-effectiveness and cost-utility of the Health Navigator Model implementation. In regard to the cost-effectiveness and cost-utility analyses, these refer to the degree to which the application of the Health Navigator Model for prevention of cancer among the homeless population is effective or productive in relation to its cost. To conduct this economic evaluation, health outcomes, such as quality of life, and the cost required to achieve the expected health and well-being results providing the Health Navigator Model will be analyzed. This analysis will be based on the data collected on health outcomes and costs (healthcare costs and cancer costs and burden) within the project.

Finally, the third objective is aimed at identifying factors acting as facilitators and barriers for an effective and successful implementation of the Health Navigator Model under the CANCERLESS project. To this aim, not only patients or users' experiences will be taken into account, but also the feedback from navigators and multidisciplinary teams participating in CANCERLESS project. Also, analyses of the differences between baseline and follow-up measurements will be performed.

University of Valencia

Ministry of Social Policies and Family, Spain

International Foundation for Integrated Care

Programs of Development, Social Support and Medical Cooperation Association

European Federation of National Organisations working with the Homeless

Anglia Ruskin University

Principal Investigator

study samples adolescent and young adult survivors of pediatric cancer, their parents, and one sibling; they are assessed using self-report questionnaires, so no intervention takes place

Questionnaires on identity formation and psychosocial functioning, assessed and reported at baseline, one year later, two years later, and five years later.

Questionnaire bundle

After obtaining informed consent, we will access the medical file of participants to obtain information on the diagnosis, time of diagnosis, treatment duration, type of treatment, and relapse (when applicable).

Obtaining information from survivors' medical file

Koen Luyckx, Dr.

The study investigators plan to conduct a longitudinal questionnaire study in adolescents and emerging adults (14-25 years of age at the start of the study) who survived childhood cancer to chart their identity development and broader social functioning. Additionally, the functioning of these survivors will be related to the functioning of their parents and siblings. The investigators shall focus especially on the current experience and impact of the earlier cancer experience. They will investigate to what extent the experience of a life-threatening disease has an effect on the daily life of survivors and over time and how the survivors develop through the course of adolescence and emerging adulthood on the psychosocial level. The formation of an adult identity is a very challenging task during adolescence and the way to adulthood and the fact that these youth had cancer during their childhood may especially complicate this process of identity formation. Furthermore, both parental and sibling functioning will be taken into account, which will allow us to examine inter-generational mechanisms (thus parental functioning that possibly impacts youth functioning and vice versa) and sibling functioning in these families. To investigate the latter, at each timepoint of the longitudinal study a sibling between 14 and 25 years of age at the start of the study will be included (if there is more than one sibling in a family, ideally the sibling who is closest in age will be the one who participates in the study). Moreover, a community sample that is matched on age and sex with the survivor of pediatric cancer will be assessed. This will allow the investigators to make well-founded comparisons regarding identity development and broader psychosocial functioning.

In the present longitudinal study, four main research questions will be investigated.

1. How does identity develop in cancer survivors? Based on previous findings from studies in identity development, it seems that young adults with a chronic disease like type 1 diabetes show less exploration or consider less identity possibilities from which they can choose, e.g. they dwell less upon the choice of education. Does this finding also apply to survivors of childhood cancer or are these youth more similar to a community sample? This research question may provide an answer to the question whether or not there is a continued (psychological) impact of childhood cancer on the later identity development of survivors. For this purpose the investigators shall make use of an identity model which was developed at their research department and which has gained much international research attention. In addition, the investigators want to look at illness-identity, which comprises the amount to which the earlier cancer experience is integrated into one's identity. Does the youngster feel still engulfed by the earlier cancer experience, or has he/she integrated this experience as part of his/her self-concept? Or does the youngster feel even enriched by the earlier cancer experience, thus did he/she end up even stronger through the experience?
2. How do survivors of pediatric cancer and/or their parents function on the psychological level, more specific on the level of life satisfaction and depressive symptoms, and what is the role of identity and personality variables herein? This question examines, among other factors, concepts like benefit-finding, post-traumatic growth, resilience,... Thereby it would be interesting to examine whether different subgroups can be identified, for example, which groups of persons display less adaptive functioning and why?
3. Are there certain parenting dimensions (e.g. overprotection, responsiveness, psychological control,...) which are more prevalent in families that were confronted with pediatric cancer and are these dimensions differently related to the psychosocial adaptation of survivors? Does this relate to certain aspects of survivor functioning, like depressive symptoms and quality of life? Thereby, transactional processes between survivor and parental functioning will be investigated, e.g. does identity development of survivors have an impact on parental well-being, and has parental well-being in turn an impact on survivor functioning? Taken together, the investigators want to investigate to what extent these contextual variables determine the functioning of adolescents and emerging adults.
4. What is the impact for siblings of cancer survivors? How do they go through their identity process? Do they experience the same parenting as the survivors experience themselves? E.g if survivors would experience more parental overprotection, would siblings experience overprotection to the same extent?

Longitudinal Identity Study of Childhood Cancer Survivors

The Long-term Impact of Pediatric Cancer on Adolescents, Emerging Adults, and Their Family: Identity, Psychosocial Functioning, and Development

Dimensions of Identity Development Scale (DIDS); dimensions: commitment making (range: 5 - 25), Identification with Commitment (range: 5 - 25), Exploration in Breadth (rang: 5 - 25), Exploration in Depth (range: 5 - 25), Ruminative Exploration (range: 5 - 25); for each dimension, a higher score indicates more identification with the dimension

Erikson Psychosocial Stage Inventory (EPSI); subscales: Synthesis (range: 5 - 30), Confusion (range: 5 - 30); for each scale, higher scores indicate more identification with the scale

Illness Centrality; total scale range: 0 - 4; A higher score indicates more identification with the scale

Self-Identity after Cancer; dimensions: victim of cancer (range: 1 - 5), cancer patient (range: 1 - 5), person who had cancer (range: 1 - 5), survivor (range: 1 - 5); for each dimension, a higher score indicates more identification with the dimension

Children's Revised Impact of Event Scale (CRIES-13); total scale range: 0 - 65; Higher scores indicate more sensitivity for PTSD; A score higher than 30 possibly indicates the presence of PTSD; subscales: Intrusion (range: 0 - 20), Avoidance (range: 0 - 20), Arousal (range: 0 - 25); Higher scores indicate more identification with the scale

Benefit scale from the Benefit and Burden Scale (BBSC); total scale range: 10 - 50; A higher score indicates more identification with the scale

Center for Epidemiologic Studies Depression (CES-D-12); total scale range: 0 - 36; a higher score indicates the presence of more depressive symptoms

Cancer Related Worries Scale; total scale range: 4 - 20; A higher score indicates the presence of more cancer-related worries

Satisfaction with Life Scale (SWLS); total scale range: 5 - 35; A higher score indicates more satisfaction with life

Short Form 36, physical subscale (SF-36); total scale range: 10 - 30: A higher score indicates worse bodily functioning

Rosenberg Self-Esteem Scale (RSES); total scale range: 10 - 40: A higher score indicates higher self-esteem

Brief Resilience Scale (BRS); total scale range: 6 - 30; A higher score corresponds to being more resilient

Big Five Inventory 10 (BFI-10); subscales: Extraversion (range: 2 - 10), Agreeableness (range: 2 - 10), Conscientiousness (range: 2 - 10), Neuroticism (range: 2 - 10), Openness (range: 2 - 10); for each scale, a higher score indicates more identification with the scale

Based on Goossens et al., 2013: Health risk behaviors in adolescents and emerging adults with congenital heart disease: psychometric properties of the Health Behavior Scale-Congenital Heart Disease

Multidimensional Health Locus of Control Scale (MHLCS): subscales: Internal Health Locus of Control (range 6 - 36), Powerful Others Health Locus of Control (range 6 - 36), Chance Health Locus of Control (range: 6 - 36); for each scale, a higher score indicates more identification with the scale

Multidimensional Scale of Perceived Social Support (MSPSS); subscales: support from special someone (range: 4 - 28), support from family (range: 4 - 28), support from friends (range: 4 - 28); for each subscale, a higher score indicates more support

Based on the 8-item Parental Expectations for Behavior Scale and the 8-item Parental Monitoring of Behavior Scale uit de 'Parental Regulation Scale - Youth Self-Report' (PRS -YSR; Barber, 2002); Behavioral Control; total scale range: 7 - 35; A higher score indicates more parental behavioral control

Child Report of Parent Behavior Inventory (CRPBI; Schaefer, 1965; Schludermann \& Schludermann, 1988); Responsiveness; total scale range: 7 - 35; A higher score indicates more parental responsiveness

based on Dutch Multidimensional Overprotective Parenting Scale, Kins \& Soenens, 2013; Overprotection / anxious parenting; Overprotection; total scale range: 8 - 40; A higher score indicates more parental overprotection

8-item Psychological Control Scale-Youth Self-Report ( Barber, 1996); Psychological Control; total scale range: 8 - 40; A higher score indicates more parental psychological control

Illness Intrusiveness Questionnaire Parent Report (IIQ-Parent Report); total scale range: 13 - 91; A higher score indicates more illness intrusiveness

Parenting Stress Index - Sense of Competence Scale; total scale range: 13 - 78; A higher score indicates a lower sense of parental competence

Parental Burden Questionnaire, subscale role restriction; total scale range: 6 - 24; A higher score indicates a greater sense of role restriction

Family Functioning Questionnaire, subscale parental relationship quality; total scale range: 5 - 20; A higher score indicates a greater sense of partner relationship quality

Benefit Finding Scale; total scale range: 15 - 105; A higher score indicates more benefit finding

Research Foundation Flanders

Universitaire Ziekenhuizen KU Leuven

KU Leuven

Associate professor at the Faculty of Psychology and Educational Sciences

Heart and Blood Diseases

Blood and Lymph Conditions

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

This is a prospective observational study in patients with symptomatic multiple myeloma who have not yet initiated therapy for their disease.

Daniel Auclair

The primary objective of this observational study is to identify the molecular profiles and clinical characteristics that define subsets of myeloma patients during the course of the disease.

Understanding the molecular basis of cancer is a critical step toward devising the most effective treatment of the patient as an individual. The promise of molecular targeted therapeutics and personalized cancer care has been demonstrated in breast and lung cancer and chronic myeloid leukemia. However, similar examples of success in multiple myeloma have not been achieved despite extensive basic research as well as clinical advances. What is well understood is that myeloma is a heterogeneous disease with great genetic and epigenetic complexity.22, 23 Therefore, there remains a critical need to understand myeloma patient biology in the context of current patient care.24 The objective of this longitudinal study is to identify patient subgroups and phenotypes defined by molecular profiling and clinical features. These profiles will enable a better understanding of mechanisms of disease, drug response and patient relapse. Ultimately the study is intended to drive successful drug development and patient care in multiple myeloma.

Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile

A Prospective, Longitudinal, Observational Study in Newly Diagnosed Multiple Myeloma (MM) Patients to Assess the Relationship Between Patient Outcomes, Treatment Regimens and Molecular Profiles

Interim Analysis data will be released every 6 months

Standard clinical and laboratory assessments. Genomic tests (DNA and RNA sequencing, etc.) on bone marrow aspirates obtained at baseline, suspected complete response, and relapse/progression.

IMWG criteria: stringent complete response, complete response, very good partial response, partial response, no response.

Progression-free survival and overall survival

Severe/CTCAE grade 3-4 adverse events (checklist)

Translational Genomics Research Institute

Spectrum Health Hospitals

Van Andel Research Institute

Multiple Myeloma Research Foundation

The program is conducted as group rehabilitation, organized by four hour weekly over 12 weeks (approximately 50 hours) with 8-10 participants in each group over three years. The program is located in Askøy Municipality's 'Health Central' and conducted by a multidisciplinary team.

The content of the program is based on prior research and clinical experience, consisting of five elements:

1. Individual goal-setting
2. Physical activity (2 hours/week) focusing on balance/coordination, cardio and strength.
3. Psychoeducation: Five teaching sessions and discussions focusing on physical activity, fatigue and late-effects, nutrition, coping, social support and work/studies. In addition, two sessions (first and last) will also include next of kin.
4. Individual follow-up: Mandatory session at the start and end of the program, otherwise based on individual request and need.
5. Peer support.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Vitaccess Real MG Registry	NCT06064461	Myasthenia Grav...		18 Years -	Vitaccess Ltd
Hyperbaric Oxygenation Treatment and Quality of Life	NCT03570229	Cancer	Hyperbaric oxyg...	-	University of Bergen
Hyperbaric Oxygenation Treatment and Quality of Life	NCT03570229	Cancer	Hyperbaric oxyg...	-	University of Bergen
Cancer Prevention Among Individuals With Mental Ill-health: Patient Navigation for Primary Cancer Prevention	NCT06435117	Cancer	Patient Navigat...	18 Years -	Medical University of Vienna
Cancer Prevention and Early Detection Among the Homeless Population: The Health Navigator Model	NCT05406687	Cancer	Health Navigato...	18 Years -	Medical University of Vienna
Vitaccess Real MG Registry	NCT06064461	Myasthenia Grav...		18 Years -	Vitaccess Ltd
Longitudinal Identity Study of Childhood Cancer Survivors	NCT03424343	Pediatric Cance...	Questionnaire b... Obtaining infor...	14 Years - 25 Years	KU Leuven
Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile	NCT01454297	Multiple Myelom...		18 Years -	Multiple Myeloma Research Foundation
Cancer Rehabilitation in Primary Health Care	NCT04316962	Cancer Survivor... All Cancers	Complex cancer ...	18 Years - 70 Years	University of Bergen
Lymphoma Patients Undergoing Mediastinal Radiotherapy in the Era of Modern Chemoradiation	NCT03969693	Mediastinal Lym... Hodgkin Lymphom... Non Hodgkin Lym...	Standard treatm...	15 Years - 80 Years	Chang Gung Memorial Hospital
Longitudinal Identity Study of Childhood Cancer Survivors	NCT03424343	Pediatric Cance...	Questionnaire b... Obtaining infor...	14 Years - 25 Years	KU Leuven
Lymphoma Patients Undergoing Mediastinal Radiotherapy in the Era of Modern Chemoradiation	NCT03969693	Mediastinal Lym... Hodgkin Lymphom... Non Hodgkin Lym...	Standard treatm...	15 Years - 80 Years	Chang Gung Memorial Hospital
Longitudinal Survey Analysis in Lymphoma Survivors	NCT01469754	Lymphoma Posttraumatic S... Posttraumatic G... Coping Resilience		18 Years -	Weill Medical College of Cornell University

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