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

Cancer Clinical Trial

— CANCERLESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05406687
• Other study ID #: 965351
• Status: Completed
• Phase: N/A
• Start date: June 8, 2022
• Est. completion date: December 29, 2023

Study information

• Verified date: January 2024
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 654
• Est. completion date: December 29, 2023
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• No diagnosed cancer

• Any category of the European Typology of Homelessness and housing exclusion applies

• Sufficient knowledge of language

Exclusion Criteria:

• Persons who cannot give consent due to diminished capacity

• Persons who do not provide informed consent

• Known cancer diagnosis

• Cancer survivorship

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Health Navigator Model
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.

Locations

Country	Name	City	State
Austria	AmberMed	Vienna
Greece	PRAKSIS Open Day Center for Homeless Athens	Athens	Attica
Greece	PRAKSIS Open Day Center for Homeless Piraeus	Piraeus	Attica
Greece	PRAKSIS Community Center	Sepolia	Attica
Spain	Centro de Salud Benita de Ávila	Madrid
Spain	Centro de Salud Casa de Campo	Madrid
Spain	Centro de Salud Cortes	Madrid
Spain	Centro de Salud Justicia	Madrid
Spain	Centro de Salud Las Águilas	Madrid
Spain	Centro de Salud Segovia	Madrid
Spain	Centro de Salud Segre	Madrid
Spain	Samur Social	Madrid
Spain	Shelter el Pinar	Madrid
Spain	Shelter San Isidro	Madrid
Spain	Shelter San Juan de Dios	Madrid
Spain	Women's centre Beatriz Galindo	Madrid
United Kingdom	The Purfleet Trust - Pathway House	King's Lynn	Norfolk
United Kingdom	Dibden Road Hostel (Part of St Martins Housing Trust)	Norwich	Norfolk

Sponsors (11)

Lead Sponsor

Collaborator

Medical University of Vienna

Anglia Ruskin University, European Federation of National Organisations working with the Homeless, International Foundation for Integrated Care, Ministry of Social Policies and Family, Spain, Programs of Development, Social Support and Medical Cooperation Association, Prolepsis Institute for Preventive, Environmental and Occupational Medicine, Senior Europa Sociedad Limitada, Servicio Madrileño de Salud, Madrid, Spain, Universitat Politècnica de València, University of Valencia

Countries where clinical trial is conducted

Austria,  Greece,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical utility/effectiveness	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.	18 months
Primary	Cost-effectiveness and cost-utility	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.	18 months
Primary	Facilitators and barriers for the Health Navigator Model implementation	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.	18 months

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