Clinical trial NCT05406687: Cancer Prevention and Early Detection Among the Homeless Population: The Health Navigator Model
Official title: Cancer Prevention and Early Detection Among the Homeless Population in Europe: Co-adapting and Implementing the Health Navigator Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Europe
Cancer
Cancer prevention
Primary care
Co-designed intervention
Implementation science
Homelessness
Homeless population
Longitudinal
Person-centered
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: University of Valencia
name: Senior Europa Sociedad Limitada
name: Ministry of Social Policies and Family, Spain
name: Servicio Madrileño de Salud, Madrid, Spain
name: International Foundation for Integrated Care
name: Programs of Development, Social Support and Medical Cooperation Association
name: European Federation of National Organisations working with the Homeless
name: Prolepsis Institute for Preventive, Environmental and Occupational Medicine
name: Anglia Ruskin University
name: Universitat Politècnica de València
First posted: 2022-06-06
Enrollment: 654
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical utility/effectiveness
timeFrame: 18 months
measure: Cost-effectiveness and cost-utility
timeFrame: 18 months
measure: Facilitators and barriers for the Health Navigator Model implementation
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: AmberMed
city: Athens
country: Greece
facility: PRAKSIS Open Day Center for Homeless Athens
state: Attica
city: Piraeus
country: Greece
facility: PRAKSIS Open Day Center for Homeless Piraeus
state: Attica
city: Sepolia
country: Greece
facility: PRAKSIS Community Center
state: Attica
city: Madrid
country: Spain
facility: Centro de Salud Segre
city: Madrid
country: Spain
facility: Centro de Salud Segovia
city: Madrid
country: Spain
facility: Samur Social
city: Madrid
country: Spain
facility: Centro de Salud Casa de Campo
city: Madrid
country: Spain
facility: Centro de Salud Cortes
city: Madrid
country: Spain
facility: Centro de Salud Justicia
city: Madrid
country: Spain
facility: Centro de Salud Benita de Ávila
city: Madrid
country: Spain
facility: Centro de Salud Las Águilas
city: Madrid
country: Spain
facility: Shelter el Pinar
city: Madrid
country: Spain
facility: Shelter San Isidro
city: Madrid
country: Spain
facility: Shelter San Juan de Dios
city: Madrid
country: Spain
facility: Women's centre Beatriz Galindo
city: King's Lynn
country: United Kingdom
facility: The Purfleet Trust - Pathway House
state: Norfolk
city: Norwich
country: United Kingdom
facility: Dibden Road Hostel (Part of St Martins Housing Trust)
state: Norfolk
Study officials:
affiliation: Medical University of Vienna
name: Igor Grabovac, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: