Cancer Prevention Among Individuals with Mental Ill-health: Patient Navigation for Primary Cancer Prevention (CO-CAPTAIN)

Cancer Prevention Among Individuals with Mental Ill-health: Co-adapting and Implementing Patient Navigation for Primary Cancer Prevention

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: Patient Navigation

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.

• Study Type: Interventional
• Enrollment (Estimated): 1240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Igor Grabovac, MD, PhD; Phone Number: +43 1 40160 34897; Email: igor.grabovac@meduniwien.ac.at
• Study Contact Backup: Name: Hanna M. Mües, MSc; Phone Number: +43 1 40160 34662; Email: hanna.muees@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria
    • Recruiting
    • Medical University of Vienna
    • Contact: Igor Grabovac; Phone Number: 004314016034897; Email: igor.grabovac@meduniwien.ac.at
  • Vienna, Austria
    • Recruiting
    • Hietzing Hospital
    • Contact: Igor Grabovac; Phone Number: 004314016034897; Email: igor.grabovac@meduniwien.ac.at
  • Vienna, Austria
    • Recruiting
    • LOGIN - Verein zur Gesundheitsförderung und sozialen Integration
    • Contact: Igor Grabovac; Phone Number: 004314016034897; Email: igor.grabovac@meduniwien.ac.at
• Greece
  • Athens, Greece
    • Recruiting
    • Mental Health Clinic
    • Contact: Mental Health Clinic
  • Athens, Greece
    • Recruiting
    • The Day Hospital
    • Contact: The Day Hospital
  • Athens, Greece
    • Recruiting
    • The Guest House / Protected apartments
    • Contact: The Guest House / Protected apartments
• Poland
  • Łódź, Poland
    • Recruiting
    • The Association of Youth and People with Mental Problems, Their Families and Friends POMOST
    • Contact: Magdalena Wrzesińska; Phone Number: 0048693037010; Email: magdalena.wrzesinska@umed.lodz.pl
• Spain
  • Madrid, Spain
    • Recruiting
    • General Directorate of Social Services, council of family, youth and social affairs, community of Madrid (DGSSI-CM)
    • Contact: Noelia Mancebo Salas; Phone Number: 0034913925528; Email: noelia.mancebo@madrid.org
  • Madrid, Spain
    • Recruiting
    • Servicio Madrileño de Salud (SERMAS)
    • Contact: Rosa Gomez Trenado; Phone Number: 0034913700942; Email: rgtrenado@salud.madrid.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health data of participants as assessed by self-report or electronic health reports	To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in health outcomes and socio-economic risk factors in the course of study participation. Next to socio-demographic data, participants will indicate their health status, alcohol consumption, sexual risk behavior, sun exposure, and vaccination status by self-report or electronic health reports.	18 months
Nutritional intake of participants as assessed by the Rapid Prime Diet Quality Score Screener (rPDQS)	To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the health outcome nutritional intake. Nutritional intake will be assessed by the Rapid Prime Diet Quality Score Screener (rPDQS; range: 0-52, where higher values indicate healthier nutritional intake).	18 months
Smoking behavior of participants as assessed by the Fagerström Test for Nicotine Dependence (FND)	To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the health outcome smoking behavior. Smoking behavior will be assessed by the Fagerström Test for Nicotine Dependence (FND; range: 0-10, where higher values indicate higher nicotine dependence).	18 months
Physical activity of participants as assessed by the International Physical Activity Questionnaire (IPAQ)	To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the health outcome physical activity. Physical activity will be assessed by the International Physical Activity Questionnaire (IPAQ; range: 0-19278 MET minutes per week, where higher values indicate more time spent on physical activity).	18 months
Depressive symptoms of participants as assessed by the Patient Health Questionnaire (PHQ-9)	To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the health outcome depressive symptoms. Depressive symptoms will be assessed by the Patient Health Questionnaire (PHQ-9; range: 0-27, where a higher score indicates more severe depressive symptoms).	18 months
Generalized anxiety of participants as assessed by the 7-item anxiety scale (GAD-7)	To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the health outcome generalized anxiety. Generalized anxiety will be assessed by the 7-item anxiety scale (GAD-7; range: 0-21, where higher values indicate more severe anxiety symptoms).	18 months
Health-related anxiety of participants as assessed by the Whiteley Index (Whiteley-6-R)	To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the health outcome health-related anxiety. Health-related anxiety will be assessed by items from the Whiteley Index (Whiteley-6-R; range: 0-24, where higher values indicate more health anxiety symptoms).	18 months
(Health-related) Quality of life of participants as assessed by the World Health Organization Quality of Life Brief Version (WHO-QOL-BREF)	To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in (health-related) quality of life. (Health-related) Quality of life will be assessed by items from the World Health Organization Quality of Life Brief Version (WHO-QOL-BREF; range: 4-20, where higher values indicate higher quality of life).	18 months
(Health-related) Quality of life of participants as assessed by the descriptive system of the EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L)	To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in (health-related) quality of life. (Health-related) Quality of life will be assessed by items from the descriptive system of the EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L, where each dimension has a range from 1-5, where a higher value indicates more severe problems).	18 months
(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)	To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in (health-related) quality of life. (Health-related) Quality of life will be assessed by items from the EQ visual analogue scale of the EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L, range: 0-100, where higher values indicate better subjective health).	18 months
Self-efficacy of participants as assessed by the General Self-Efficacy Scale (GSES)	To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in self-efficacy. Self-efficacy will be assessed by items from the General Self-Efficacy Scale (GSES; range: 10-40, where higher values indicate higher perceived self-efficacy).	18 months
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)	To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in feeling understood and supported by healthcare providers (HPS) as part of health literacy. HPS as part of health literacy will be assessed by items of the HPS scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-4, where higher values indicate higher perceived HPS).	18 months
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)	To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in having sufficient information to manage one's own health as part of health literacy. Having sufficient information to manage my health (HSI) as part of health literacy will be assessed by items of the HSI scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-4, where higher values indicate higher perceived HSI).	18 months
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)	To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in actively managing one's own health as part of health literacy. Actively managing my health (AMH) as part of health literacy will be assessed by items of the AMH scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-4, where higher values indicate higher perceived AMH).	18 months
Social support as part of health literacy of participants as assessed by the Social support of health scale of the Health Literacy Questionnaire (HLQ)	To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in social support as part of health literacy. Social support as part of health literacy will be assessed by items of the social support of health scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-4, where higher values indicate higher perceived social support for health).	18 months
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)	To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in appraisal of health information as part of health literacy. Appraisal of health information (CA) as part of health literacy will be assessed by items of the CA scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-4, where higher values indicate higher perceived CA).	18 months
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)	To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the ability to actively engage with healthcare providers as part of health literacy. Ability to actively engage with healthcare providers (AE) as part of health literacy will be assessed by items of the AE scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-5, where higher values indicate higher perceived AE).	18 months
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)	To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the ability to navigate the healthcare system as part of health literacy. Navigating the healthcare system (NHS) as part of health literacy will be assessed by items of the NHS scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-5, where higher values indicate higher perceived NHS).	18 months
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)	To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the ability to find good health information as part of health literacy. Ability to find good health information (FHI) as part of health literacy will be assessed by items of the FHI scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-5, where higher values indicate higher perceived FHI).	18 months
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)	To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the ability to understand health information well enough to know what to do as part of health literacy. Understanding health information well enough to know what to do as part of health literacy will be assessed by items of the Understand health information well enough to know what to do (UHI) scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-5, where higher values indicate higher perceived UHI).	18 months
Use of healthcare services of participants as assessed by self-reports	To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in use of healthcare services. Use of healthcare services will be assessed by self-reports.	18 months
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	To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by evaluating cost-effectiveness and cost-utility. To assess cost-effectiveness and cost-utility of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, an economic evaluation will be carried out by analyzing health outcomes and costs (healthcare costs, cancer costs, burden).	18 months
Satisfaction with care of participants as assessed by self-reports and items from the Patient Satisfaction Questionnaire Short Form (PSQ-18)	To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in satisfaction with care. Satisfaction with care will be assessed by self-reports and items from the Patient Satisfaction Questionnaire Short Form (PSQ-18, range of the mean score: 1-5, where higher scores indicate higher satisfaction with medical care).	18 months
Discrimination experiences of participants as assessed by self-reports	To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in discrimination experiences. Discrimination experiences will be assessed by self-reports.	18 months
Facilitators of the Patient Navigation Model as experienced by participants and assessed by qualitative semi-structured interviews	The co-adapted Patient Navigation Model will be evaluated by assessing facilitators of the intervention to determine its effectiveness. Experiences of people with mental ill-health, navigators, and healthcare professionals involved in care of people with mental ill-health will be considered. Qualitative data will be gathered using semi-structured interviews.	18 months
Barriers of the Patient Navigation Model as experienced by participants and assessed by qualitative semi-structured interviews	The co-adapted Patient Navigation Model will be evaluated by assessing barriers of the intervention to determine its effectiveness. Experiences of people with mental ill-health, navigators, and healthcare professionals involved in care of people with mental ill-health will be considered. Qualitative data will be gathered using semi-structured interviews.	18 months

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Medical University of Lodz; Servicio Madrileño de Salud, Madrid, Spain; Universitat Politècnica de València; Prolepsis Institute for Preventive, Environmental and Occupational Medicine; Senior Europa Sociedad Limitada; University Mental Health Research Institute, Athens, Greece; STICHTING INTERNATIONAL FOUNDATION FOR INTEGRATED CARE; Consejería de Familia, Juventud y Política Social, Comunidad de Madrid; Fundacion para la Investigacion e Innovacion Biosanitaria de Atencion Primaria; Mental Health Europe - Sante Mentale Europe; Fundacion para el Fomento en Asturias de la Investigacion Cientifica Aplicada y Tecnologia; Consejeria de Salud - Principado de Asturias; Servicio de Salud del Principado de Asturias
• Investigators: Principal Investigator: Igor Grabovac, MD, PhD, Medical University of Vienna

Publications and helpful links

Helpful Links

• HORIZON EUROPE

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; Patient Navigation; Prevention; Mental health; Primary prevention; Longitudinal; Cancer prevention; Implementation science; Europe; Person-centered; Mental health problems; Co-design
• Other Study ID Numbers: 101104784

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon request from other researchers, the principal investigator may provide study materials and data in an anonymised and limited form, while adhering to the Data Security Department of the Medical University of Vienna.
• IPD Sharing Time Frame: Accessibility is expected after completion of the study as well as of related publications. Only data that does not allow identification of participants will be made available.
• IPD Sharing Access Criteria: Upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No