Trial Title:
Cancer Prevention Among Individuals With Mental Ill-health: Patient Navigation for Primary Cancer Prevention
NCT ID:
NCT06435117
Condition:
Cancer
Conditions: Keywords:
Europe
Prevention
Cancer
Cancer prevention
Primary prevention
Mental health
Mental health problems
Patient Navigation
Implementation science
Co-design
Longitudinal
Person-centered
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Patient Navigation
Description:
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.
Arm group label:
People with mental ill-health
Summary:
Prevention is essential for reducing cancer-related mortality. However, people with
mental ill-health often face difficulties in accessing cancer prevention services. The
EU-funded CO-CAPTAIN project aims to co-adapt and implement the Patient Navigation Model
for primary cancer prevention in this underserved population. This evidence-based and
patient-centred intervention aims to support patient empowerment through removal of
systemic barriers, provide social support and promote timely access to primary prevention
services.
Detailed description:
Cancer and mental ill-health constitute leading public health problems in Europe. More
than 84 million people in the European Union (EU) report living with an on-going mental
ill-health condition. While issues concerning mental health are of great importance, they
often overshadow physical problems that people with mental ill-health face. Such is
cancer, which is more prevalent in people with mental ill-health and is also the second
most common cause of death in this population. People with mental ill-health often have
difficulties in accessing quality cancer prevention services, but are also additionally
overlooked in research which makes them overall an underserved population. What data is
available, shows that potential reasons for these higher cancer morbidity and mortality
rates are linked to more engagement in risky health behaviour (especially higher
prevalence of smoking as well as overweight and obesity) but also experiences of
significant barriers when accessing the highly fragmented heath care systems.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18 years of age or older
- 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 unable to give consent due to diminished capacity
- Individuals who do not provide consent
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Hietzing Hospital
Address:
City:
Vienna
Country:
Austria
Contact:
Last name:
Hietzing Hospital
Facility:
Name:
Medical University of Vienna
Address:
City:
Vienna
Country:
Austria
Contact:
Last name:
Medical University of Vienna
Facility:
Name:
Mental Health Clinic
Address:
City:
Athens
Country:
Greece
Contact:
Last name:
Mental Health Clinic
Facility:
Name:
The Day Hospital
Address:
City:
Athens
Country:
Greece
Contact:
Last name:
The Day Hospital
Facility:
Name:
The Guest House / Protected apartments
Address:
City:
Athens
Country:
Greece
Contact:
Last name:
The Guest House / Protected apartments
Facility:
Name:
The Association of Youth and People with Mental Problems, Their Families and Friends POMOST
Address:
City:
Łódź
Country:
Poland
Contact:
Last name:
POMOST
Facility:
Name:
Servicio Madrileño de Salud (SERMAS)
Address:
City:
Madrid
Country:
Spain
Start date:
June 2024
Completion date:
September 2025
Lead sponsor:
Agency:
Medical University of Vienna
Agency class:
Other
Collaborator:
Agency:
Senior Europa Sociedad Limitada
Agency class:
Other
Collaborator:
Agency:
Prolepsis Institute for Preventive, Environmental and Occupational Medicine
Agency class:
Other
Collaborator:
Agency:
Universitat Politècnica de València
Agency class:
Other
Collaborator:
Agency:
STICHTING INTERNATIONAL FOUNDATION FOR INTEGRATED CARE
Agency class:
Other
Collaborator:
Agency:
Medical University of Lodz
Agency class:
Other
Collaborator:
Agency:
Consejería de Familia, Juventud y Política Social, Comunidad de Madrid
Agency class:
Other
Collaborator:
Agency:
Servicio Madrileño de Salud, Madrid, Spain
Agency class:
Other
Collaborator:
Agency:
Fundacion para la Investigacion e Innovacion Biosanitaria de Atencion Primaria
Agency class:
Other
Collaborator:
Agency:
Mental Health Europe - Sante Mentale Europe
Agency class:
Other
Collaborator:
Agency:
University Mental Health Research Institute, Athens, Greece
Agency class:
Other
Collaborator:
Agency:
Fundacion para el Fomento en Asturias de la Investigacion Cientifica Aplicada y Tecnologia
Agency class:
Other
Collaborator:
Agency:
Consejeria de Salud - Principado de Asturias
Agency class:
Other
Collaborator:
Agency:
Servicio de Salud del Principado de Asturias
Agency class:
Other
Source:
Medical University of Vienna
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06435117
https://cordis.europa.eu/project/id/101104784
