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

NCT05406687 | Completed

• 1 other identifier: 965351
• Study Type: interventional
• Target: 654
• Locations: 4 countries
• Sites: 18

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.

Conditions

Cancer

Keywords

Europe; Cancer; Cancer prevention; Primary care; Co-designed intervention; Implementation science; Homelessness; Homeless population; Longitudinal; Person-centered

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

People experiencing homelessness

OTHER

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.

Other: Health Navigator Model

Interventions

Health Navigator Model OTHER

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.

People experiencing homelessness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• No diagnosed cancer
• Sufficient knowledge of language

You may not qualify if:

• Persons who cannot give consent due to diminished capacity
• Persons who do not provide informed consent
• Known cancer diagnosis
• Cancer survivorship

Sponsors & Collaborators

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

Study Sites (18)

AmberMed

Vienna, 1230, Austria

Location

PRAKSIS Open Day Center for Homeless Athens

Athens, Attica, 104 37, Greece

Location

PRAKSIS Open Day Center for Homeless Piraeus

Piraeus, Attica, 185 31, Greece

Location

PRAKSIS Community Center

Sepolia, Attica, 104 42, Greece

Location

Centro de Salud Segre

Madrid, 28002, Spain

Location

Centro de Salud Segovia

Madrid, 28005, Spain

Location

Samur Social

Madrid, 28005, Spain

Location

Centro de Salud Casa de Campo

Madrid, 28008, Spain

Location

Centro de Salud Cortes

Madrid, 28014, Spain

Location

Centro de Salud Justicia

Madrid, 28014, Spain

Location

Centro de Salud Benita de Ávila

Madrid, 28043, Spain

Location

Centro de Salud Las Águilas

Madrid, 28044, Spain

Location

Shelter el Pinar

Madrid, 28054, Spain

Location

Shelter San Isidro

Madrid, 28808, Spain

Location

Shelter San Juan de Dios

Madrid, Spain

Location

Women's centre Beatriz Galindo

Madrid, Spain

Location

The Purfleet Trust - Pathway House

Kings Lynn, Norfolk, PE30 1PH, United Kingdom

Location

Dibden Road Hostel (Part of St Martins Housing Trust)

Norwich, Norfolk, NR3 4SN, United Kingdom

Location

Related Publications (1)

• Carmichael C, Schiffler T, Smith L, Moudatsou M, Tabaki I, Donate-Martinez A, Alhambra-Borras T, Kouvari M, Karnaki P, Gil-Salmeron A, Grabovac I. Barriers and facilitators to health care access for people experiencing homelessness in four European countries: an exploratory qualitative study. Int J Equity Health. 2023 Oct 6;22(1):206. doi: 10.1186/s12939-023-02011-4.

  PMID: 37803317 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Neoplasms

Study Officials

• Igor Grabovac, MD, PhD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: June 6, 2022
• Study Start: June 8, 2022
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: January 8, 2024

Record last verified: 2024-01

Locations

GB (2); AU (1); GR (3); ES (12)