Clinical trial NCT06435117: Cancer Prevention Among Individuals with Mental Ill-health: Patient Navigation for Primary Cancer Prevention
Official title: Cancer Prevention Among Individuals with Mental Ill-health: Co-adapting and Implementing Patient Navigation for Primary Cancer Prevention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Europe
Prevention
Cancer
Cancer prevention
Primary prevention
Mental health
Mental health problems
Patient Navigation
Implementation science
Co-design
Longitudinal
Person-centered
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Senior Europa Sociedad Limitada
name: Prolepsis Institute for Preventive, Environmental and Occupational Medicine
name: Universitat Politècnica de València
name: STICHTING INTERNATIONAL FOUNDATION FOR INTEGRATED CARE
name: Medical University of Lodz
name: Consejería de Familia, Juventud y Política Social, Comunidad de Madrid
name: Servicio Madrileño de Salud, Madrid, Spain
name: Fundacion para la Investigacion e Innovacion Biosanitaria de Atencion Primaria
name: Mental Health Europe - Sante Mentale Europe
name: University Mental Health Research Institute, Athens, Greece
name: Fundacion para el Fomento en Asturias de la Investigacion Cientifica Aplicada y Tecnologia
name: Consejeria de Salud - Principado de Asturias
name: Servicio de Salud del Principado de Asturias
First posted: 2024-05-30
Enrollment: 1240
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 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.

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

Primary outcomes:
measure: Health data of participants as assessed by self-report or electronic health reports
timeFrame: 18 months
measure: Nutritional intake of participants as assessed by the Rapid Prime Diet Quality Score Screener (rPDQS)
timeFrame: 18 months
measure: Smoking behavior of participants as assessed by the Fagerström Test for Nicotine Dependence (FND)
timeFrame: 18 months
measure: Physical activity of participants as assessed by the International Physical Activity Questionnaire (IPAQ)
timeFrame: 18 months
measure: Depressive symptoms of participants as assessed by the Patient Health Questionnaire (PHQ-9)
timeFrame: 18 months
measure: Generalized anxiety of participants as assessed by the 7-item anxiety scale (GAD-7)
timeFrame: 18 months
measure: Health-related anxiety of participants as assessed by the Whiteley Index (Whiteley-6-R)
timeFrame: 18 months
measure: (Health-related) Quality of life of participants as assessed by the World Health Organization Quality of Life Brief Version (WHO-QOL-BREF)
timeFrame: 18 months
measure: (Health-related) Quality of life of participants as assessed by the descriptive system of the EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L)
timeFrame: 18 months
measure: (Health-related) Quality of life of participants as assessed by the EQ visual analogue scale of the EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L)
timeFrame: 18 months
measure: Self-efficacy of participants as assessed by the General Self-Efficacy Scale (GSES)
timeFrame: 18 months
measure: Feeling understood and supported by healthcare providers as part of health literacy of participants as assessed by the Feeling understood and supported by healthcare providers (HPS) scale of the Health Literacy Questionnaire (HLQ)
timeFrame: 18 months
measure: Having sufficient information to manage one's own health as part of health literacy of participants as assessed by the Having sufficient information to manage my health (HSI) scale of the Health Literacy Questionnaire (HLQ)
timeFrame: 18 months
measure: Actively managing one's own health as part of health literacy of participants as assessed by the Actively managing my health (AMH) scale of the Health Literacy Questionnaire (HLQ)
timeFrame: 18 months
measure: Social support as part of health literacy of participants as assessed by the Social support of health scale of the Health Literacy Questionnaire (HLQ)
timeFrame: 18 months
measure: Appraisal of health information as part of health literacy of participants as assessed by the Appraisal of health information (CA) scale of the Health Literacy Questionnaire (HLQ)
timeFrame: 18 months
measure: Ability to actively engage with healthcare providers as part of health literacy of participants as assessed by the Ability to actively engage with healthcare providers (AE) scale of the Health Literacy Questionnaire (HLQ)
timeFrame: 18 months
measure: Navigating the healthcare system as part of health literacy of participants as assessed by the Navigating the healthcare system (NHS) scale of the Health Literacy Questionnaire (HLQ)
timeFrame: 18 months
measure: Ability to find good health information as part of health literacy of participants as assessed by the Ability to find good health information (FHI) scale of the Health Literacy Questionnaire (HLQ)
timeFrame: 18 months
measure: Understand health information well enough to know what to do as part of health literacy of participants as assessed by the Understand health information well enough to know what to do (UHI) scale of the Health Literacy Questionnaire (HLQ)
timeFrame: 18 months
measure: Use of healthcare services of participants as assessed by self-reports
timeFrame: 18 months
measure: Cost-effectiveness and cost-utility of the Patient Navigation Model for primary cancer prevention in people with mental ill-health as assessed by an economic evaluation
timeFrame: 18 months
measure: Satisfaction with care of participants as assessed by self-reports and items from the Patient Satisfaction Questionnaire Short Form (PSQ-18)
timeFrame: 18 months
measure: Discrimination experiences of participants as assessed by self-reports
timeFrame: 18 months
measure: Facilitators of the Patient Navigation Model as experienced by participants and assessed by qualitative semi-structured interviews
timeFrame: 18 months
measure: Barriers of the Patient Navigation Model as experienced by participants and assessed by qualitative semi-structured interviews
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Hietzing Hospital
city: Vienna
country: Austria
facility: LOGIN - Verein zur Gesundheitsförderung und sozialen Integration
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Athens
country: Greece
facility: Mental Health Clinic
city: Athens
country: Greece
facility: The Day Hospital
city: Athens
country: Greece
facility: The Guest House / Protected apartments
city: Łódź
country: Poland
facility: The Association of Youth and People with Mental Problems, Their Families and Friends POMOST
city: Madrid
country: Spain
facility: General Directorate of Social Services, council of family, youth and social affairs, community of Madrid (DGSSI-CM)
city: Madrid
country: Spain
facility: Servicio Madrileño de Salud (SERMAS)
Study officials:
affiliation: Medical University of Vienna
name: Igor Grabovac, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: