Cancer Prevention Among Individuals with Mental Ill-health: Patient Navigation for Primary Cancer Prevention
NCT ID: NCT06435117
Last Updated: 2025-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1240 participants
INTERVENTIONAL
2024-06-24
2025-09-30
Brief Summary
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Detailed Description
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Timely and evidence-based preventive strategies including optimizing health care pathways provide a solution to the high cancer morbidity and could improve overall health outcomes in this disadvantaged population. One such mixed-skill strategy is Patient Navigation. Therefore, the overall goal of the CO-CAPTAIN project is to co-adapt the Patient Navigation (PN) model focusing on primary cancer prevention and to see if this model can prove to be beneficial in supporting individuals with mental ill-health through care services to reduce cancer risk factors by increasing knowledge, health literacy and empowerment. The Patient Navigation Model is an innovative, evidence-based and patient-centred intervention, which supports patient empowerment through removal of systemic barriers, providing social support and promoting timely access to primary prevention services. Based on implementation science and utilizing the Consolidated Framework for Implementation (CFIR) as well as the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks, the CO-CAPTAIN project aims to reduce the gap in health inequalities for people with mental ill-health by reducing cancer burden and improving overall health, which will, in turn, reduce associated costs across health and social care systems in Europe. Moreover, the CO-CAPTAIN project aims to harness the transformative potential of the integrated care pathways in cancer as well as provide health and social care policy recommendations for the adoption and implementation of the Patient Navigation Model across Europe.
The adapted Patient Navigation Model will be implemented in four European countries (Austria, Greece, Poland, Spain) and its potential to enable and improve access and utilization of primary cancer prevention measures for people with mental ill-health will be evaluated. The study will employ a mixed-methods design allowing for both exploratory and confirmatory research.
The project has been funded by the HORIZON EUROPE Framework Program (Call: Research and Innovation actions supporting the implementation of the Mission on Cancer (HORIZON-MISS-2022-CANCER-01-01) - Improving and upscaling primary prevention of cancer through implementation research) and is coordinated by the Medical University of Vienna.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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People with mental ill-health
All people with mental ill-health aged 18 or older who visit one of the recruitment sites will be asked to participate. Further participants will be recruited through partner organizations (non-governmental organisations, patient groups and professional organisations) involved in care for individuals with mental ill-health, as well as personal contacts. Additionally, healthcare professionals involved in care of people with mental ill-health will be asked to participate in the qualitative part of the study.
Patient Navigation
CO-CAPTAIN focuses on co-designing and piloting and evaluating the implementation of patient navigation (PN) for primary cancer prevention in people with mental ill-health. Patient Navigators, trained professionals with experience working with people with mental ill-health, will assist people with mental ill-health in gaining access to and utilizing appropriate primary cancer prevention measures offered within the respective healthcare and social system (including smoking cessation and physical activity and nutritional interventions). For this purpose, Patient Navigators will offer regular appointment with participants, apply motivational interviewing and aid in accessing appropriate materials while aiming at empowering participants in taking an active role and making better and more informed decisions regarding their health.
Interventions
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Patient Navigation
CO-CAPTAIN focuses on co-designing and piloting and evaluating the implementation of patient navigation (PN) for primary cancer prevention in people with mental ill-health. Patient Navigators, trained professionals with experience working with people with mental ill-health, will assist people with mental ill-health in gaining access to and utilizing appropriate primary cancer prevention measures offered within the respective healthcare and social system (including smoking cessation and physical activity and nutritional interventions). For this purpose, Patient Navigators will offer regular appointment with participants, apply motivational interviewing and aid in accessing appropriate materials while aiming at empowering participants in taking an active role and making better and more informed decisions regarding their health.
Eligibility Criteria
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Inclusion Criteria
* Individuals who have been diagnosed with one or more mental disorders OR healthcare professionals involved in care of individuals with mental ill-health
* Sufficient knowledge of language
Exclusion Criteria
* Individuals who do not provide consent
18 Years
ALL
Yes
Sponsors
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Medical University of Vienna
OTHER
Senior Europa Sociedad Limitada
UNKNOWN
Prolepsis Institute for Preventive, Environmental and Occupational Medicine
OTHER
Universitat Politècnica de València
OTHER
STICHTING INTERNATIONAL FOUNDATION FOR INTEGRATED CARE
UNKNOWN
Medical University of Lodz
OTHER
Consejería de Familia, Juventud y Política Social, Comunidad de Madrid
UNKNOWN
Servicio Madrileño de Salud, Madrid, Spain
OTHER
Fundacion para la Investigacion e Innovacion Biosanitaria de Atencion Primaria
UNKNOWN
Mental Health Europe - Sante Mentale Europe
UNKNOWN
University Mental Health Research Institute, Athens, Greece
OTHER
Fundacion para el Fomento en Asturias de la Investigacion Cientifica Aplicada y Tecnologia
UNKNOWN
Consejeria de Salud - Principado de Asturias
UNKNOWN
Servicio de Salud del Principado de Asturias
UNKNOWN
Responsible Party
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Igor Grabovac
Project coordinator
Principal Investigators
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Igor Grabovac, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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Hietzing Hospital
Vienna, , Austria
LOGIN - Verein zur Gesundheitsförderung und sozialen Integration
Vienna, , Austria
Medical University of Vienna
Vienna, , Austria
Mental Health Clinic
Athens, , Greece
The Day Hospital
Athens, , Greece
The Guest House / Protected apartments
Athens, , Greece
The Association of Youth and People with Mental Problems, Their Families and Friends POMOST
Lodz, , Poland
General Directorate of Social Services, council of family, youth and social affairs, community of Madrid (DGSSI-CM)
Madrid, , Spain
Servicio Madrileño de Salud (SERMAS)
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Mental Health Clinic
Role: primary
The Day Hospital
Role: primary
The Guest House / Protected apartments
Role: primary
Related Links
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HORIZON EUROPE
Other Identifiers
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101104784
Identifier Type: -
Identifier Source: org_study_id
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