CancerCANCERLESSNCT05406687
Cancer Prevention and Early Detection Among the Homeless Population: The Health Navigator Model
A study testing Health Navigator Model in people with Cancer, run by Medical University of Vienna at 18 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Health Navigator Model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 654 participants
- Where
- 18 sitesin 4 countries
- Study dates
- 8 Jun 2022to 29 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Persons who cannot give consent due to diminished capacity
- Persons who do not provide informed consent
- Known cancer diagnosis
- Cancer survivorship
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
Spain12 sites
Centro de Salud Segre
Madrid, 28002
Centro de Salud Segovia
Madrid, 28005
Samur Social
Madrid, 28005
Centro de Salud Casa de Campo
Madrid, 28008
Centro de Salud Cortes
Madrid, 28014
Centro de Salud Justicia
Madrid, 28014
Centro de Salud Benita de Ávila
Madrid, 28043
Centro de Salud Las Águilas
Madrid, 28044
Shelter el Pinar
Madrid, 28054
Shelter San Isidro
Madrid, 28808
Shelter San Juan de Dios
Madrid
Women's centre Beatriz Galindo
Madrid
Greece3 sites
PRAKSIS Open Day Center for Homeless Athens
Athens, Attica, 104 37
PRAKSIS Open Day Center for Homeless Piraeus
Piraeus, Attica, 185 31
PRAKSIS Community Center
Sepolia, Attica, 104 42
United Kingdom2 sites
The Purfleet Trust - Pathway House
Kings Lynn, Norfolk, PE30 1PH
Dibden Road Hostel (Part of St Martins Housing Trust)
Norwich, Norfolk, NR3 4SN
About this study
Official title: Cancer Prevention and Early Detection Among the Homeless Population in Europe: Co-adapting and Implementing the 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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Health Navigator Model
- Keywords
- Europe, Cancer, Cancer prevention, Primary care, Co-designed intervention, Implementation science, Homelessness, Homeless population, Longitudinal, Person-centered
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Navigator ModelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Health Navigator Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start8 Jun 2022
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 654 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Igor Grabovac, Medical University of Vienna
- Investigators
- Igor Grabovac, MD, PhD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406687
- Sponsor's protocol ID
- 965351
- Acronym
- CANCERLESS
- Status last verified
- Jan 2024
- First submitted
- 19 May 2022
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
Fragner T, Alhambra-Borras T, Donate-Martinez A, Blanes-Selva V, Garcia-Gomez JM, Gawronska J, Moudatsou M, Tabaki I, Belogianni K, Karnaki P, Varade MR, Trenado RG, Barrio-Cortes J, Smith L, Gil-Salmeron A, Grabovac I. Empowerment and quality of life through cancer prevention in people experiencing homelessness: evaluating the Health Navigator Model. Health Qual Life Outcomes. 2026 Jul 19. doi: 10.1186/s12955-026-02588-8. Online ahead of print.
PubMed 42471660Carmichael 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.
PubMed 37803317
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Prevention and Early Detection Among the Homeless Population in Europe: Co-adapting and Implementing the Health Navigator Model
- ClinicalTrials.gov ID
- NCT05406687
- Acronym / sponsor ID
- CANCERLESS / 965351
- Conditions
- Cancer
- Keywords
- Europe, Cancer, Cancer prevention, Primary care, Co-designed intervention, Implementation science, Homelessness, Homeless population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 654 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- 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
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 6 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People experiencing homelessness | Other | Other: Health Navigator ModelAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Persons who cannot give consent due to diminished capacity
- Persons who do not provide informed consent
- Known cancer diagnosis
- Cancer survivorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Navigator ModelThe 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. | Other | People experiencing homelessness |
Primary outcome
Clinical utility/effectiveness
Time frame: 18 months
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.
Cost-effectiveness and cost-utility
Time frame: 18 months
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.
Facilitators and barriers for the Health Navigator Model implementation
Time frame: 18 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Derived from this study: PubMed 42471660Fragner T, Alhambra-Borras T, Donate-Martinez A, Blanes-Selva V, Garcia-Gomez JM, Gawronska J, Moudatsou M, Tabaki I, Belogianni K, Karnaki P, Varade MR, Trenado RG, Barrio-Cortes J, Smith L, Gil-Salmeron A, Grabovac I. Empowerment and quality of life through cancer prevention in people experiencing homelessness: evaluating the Health Navigator Model. Health Qual Life Outcomes. 2026 Jul 19. doi: 10.1186/s12955-026-02588-8. Online ahead of print.
- Derived from this study: PubMed 37803317Carmichael 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor Grabovac, MD, PhD principal investigator
Medical University of Vienna
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Navigator Model in people with Cancer, run by Medical University of Vienna at 18 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Spain, Greece, United Kingdom, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical utility/effectiveness (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05406687, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.