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

Igor Grabovac, MD, PhD

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

Senior Europa Sociedad Limitada

Ministry of Social Policies and Family, Spain

Servicio Madrileño de Salud, Madrid, Spain

International Foundation for Integrated Care

Programs of Development, Social Support and Medical Cooperation Association

European Federation of National Organisations working with the Homeless

Prolepsis Institute for Preventive, Environmental and Occupational Medicine

Anglia Ruskin University

Universitat Politècnica de València

Medical University of Vienna

Principal Investigator

All Drugs and Chemicals

Nicotine

Varenicline

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

Participants will receive NRT and Motivational Interviewing counseling

Motivational Interviewing; 8 weeks of counseling

Varenicline plus Motivational Interviewing counseling

Brief advice, one time during initial session

Varenicline without counseling

Kolawole S Okuyemi, MD,MPH

the purpose of the study is to see if varenicline in combination with motivational counseling helps homeless cigarette smokers quit smoking.

Despite significant declines in cigarette smoking rates among adults in the United States in the last few decades, smoking rates remain high among poor and underserved populations. One underserved group is the 4 million homeless persons in the US among whom cigarette smoking rate is an alarming 70% or more; these rates are 3 times higher than national average. Two of the three leading causes of death among homeless persons, heart disease and cancer are tobacco related.2, 3 Despite very high smoking prevalence and disease burden in this population smoking cessation research have not been extended to the homeless. Recent studies including data from our research team show a considerable degree of readiness to quit smoking by homeless smokers and that nicotine replacement therapy (NRT) plus counseling show promise. However, homeless persons face many challenges that may constitute barriers for them to adhere to smoking cessation treatments even if such treatments have been proven effective in the general population. In order to reduce smoking-related health disparities within this underserved population, it is critical that cessation interventions including strategies to improve treatment adherence be developed to include homeless smokers. The primary aim of this study is to assess the effects of adherence-focused motivational interviewing (MI) to help homeless persons quit smoking.

Recruitment and retention will be enhanced by use of bus passes for transportation, debit cards, attractive intervention materials, collaboration with homeless shelters, and advice from a community advisory board. If successful, this study will provide a model for how to overcome barriers to cancer prevention services among homeless persons. It will also provide the impetus for policy changes directed at increasing homeless persons' access to smoking cessation pharmacotherapy and treatment.

Improving Varenicline Adherence and Outcomes in Homeless Smokers

University of Minnesota

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Participants assigned to this arm will be given basic educational materials on general lung health and referred back to their primary care provider (PCP) for management as per usual practice.

Participants assigned to this arm will be informed about lung cancer screening (LCS), provided educational materials on LCS and patient navigation, and offered access to an LCS navigator who will partner with participants and primary care providers (PCPs) to facilitate low-dose computed tomography (LDCT) completion and follow-up.

The navigator's principal role is to guide participants through the lung cancer screening (LCS) process. The navigator will work within the existing Boston Health Care for the Homeless (BHCHP) clinical structure and collaborate with participants' primary care providers (PCPs) to facilitate LCS low-dose computed tomography (LDCT) referral, completion, and timely follow-up by addressing participants' barriers to LCS completion and enhancing participants' self-efficacy. The navigator's secondary role is to offer brief tobacco counseling for participants who currently smoke.

Patient Navigation

Travis P Baggett, MD, MPH

The investigators will conduct a pragmatic clinical trial to test the effect of patient navigation on lung cancer screening (LCS) low-dose computed tomography (LDCT) completion among Boston Health Care for the Homeless Program (BHCHP) patients at increased risk for lung cancer. Patient navigation is a strategy for guiding individuals through complex health systems, and the investigators hypothesize that this may be a promising approach for helping homeless-experienced people overcome their unique barriers to obtaining LCS.

The investigators will aim to recruit 300 people to participate in this research study; 100 will be randomly assigned to arm 1 (usual care) and 200 will be randomly assigned to arm 2 (patient navigation). Randomization of participants will be stratified by smoking status, housing status, clinical site, and whether they have previously discussed LCS with their primary care provider (PCP) to ensure balance between study groups on these variables. People assigned to the usual care arm will be referred back to their PCP for further management. People assigned to the patient navigation arm will be given the chance to work with a LCS navigator. The navigator will assist participants and their PCPs with all aspects of the LCS process in addition to offering brief tobacco counseling for current smokers.

The primary aim of the trial is to determine-among homeless-experienced people who are eligible for LCS-the effect of patient navigation on 1) LCS LDCT completion at 6 months post-enrollment and 2) LCS LDCT completion at 6 months with diagnostic follow-up of abnormal results within 1 month of the recommended time frame. Study outcomes will be assessed by examining participant health records.

Following the intervention, qualitative interviews will be conducted with 40 participants and 10 BHCHP PCPs to better understand how the LCS process unfolds in the setting of homelessness, the ways in which the navigator facilitated this process, and opportunities for improving the navigation intervention for future use.

Participants will be randomized in a 2:1 ratio to usual care with (N=200) or without (N=100) lung cancer screening (LCS) navigation. Randomization will be stratified by smoking status, housing status, clinical site, and whether participants have already discussed LCS with their primary care provider (PCP) to ensure balance between study arms on these variables.

Lung Cancer Screening Navigation for Homeless People

Lung Cancer Screening Navigation for Homeless People: A Pragmatic Trial

Time between date of randomization and date of receipt of low-dose computed tomography (LDCT) for lung cancer screening (LCS) or date of censoring (6 months / 26 weeks)

This outcome will be based on radiology records verifying that a chest computed tomography (CT) was performed for LCS and interpreted according to the lung imaging reporting and data system (Lung-RADS) framework.

Participants must achieve the primary outcome and, if the result is abnormal (lung imaging reporting and data system lung imaging reporting and data system (Lung-RADS) category 3 or 4), also obtain the next recommended follow-up test within 1 month (4 weeks) of the advised timeframe based on the Lung-RADS framework. Radiology records will be obtained for participants who underwent LDCT for LCS to document the findings of the study, determine the Lung-RADS category associated with those findings, and ascertain the recommended diagnostic follow-up plan.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cancer Prevention and Early Detection Among the Homeless Population: The Health Navigator Model	NCT05406687	Cancer	Health Navigato...	18 Years -	Medical University of Vienna
Improving Varenicline Adherence and Outcomes in Homeless Smokers	NCT00786149	Tobacco Use Ces...	Varenicline plu... Varenicline wit...	18 Years -	University of Minnesota
Lung Cancer Screening Navigation for Homeless People	NCT04308226	Lung Cancer Tobacco Use Homelessness	Patient Navigat...	55 Years - 77 Years	Massachusetts General Hospital
Improving Varenicline Adherence and Outcomes in Homeless Smokers	NCT00786149	Tobacco Use Ces...	Varenicline plu... Varenicline wit...	18 Years -	University of Minnesota

Spots Global Cancer Trial Database for homelessness

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