CancerCO-CAPTAINNCT06435117
Cancer Prevention Among Individuals with Mental Ill-health: Patient Navigation for Primary Cancer Prevention
A study testing Patient Navigation in people with Cancer, run by Medical University of Vienna at 9 sites in 4 countries.
Trial 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… 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?
- Patient Navigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,240 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 24 Jun 2024to Sep 2025
- 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
- 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
Who cannot join
- Individuals unable to give consent due to diminished capacity
- Individuals who do not provide consent
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Austria3 sites, 3 recruiting
- Recruiting
Hietzing Hospital
Vienna
Igor Grabovac, 004314016034897, igor.grabovac@meduniwien.ac.at
- Recruiting
LOGIN - Verein zur Gesundheitsförderung und sozialen Integration
Vienna
Igor Grabovac, 004314016034897, igor.grabovac@meduniwien.ac.at
- Recruiting
Medical University of Vienna
Vienna
Igor Grabovac, 004314016034897, igor.grabovac@meduniwien.ac.at
Greece3 sites, 3 recruiting
- Recruiting
Mental Health Clinic
Athens
Mental Health Clinic
- Recruiting
The Day Hospital
Athens
The Day Hospital
- Recruiting
The Guest House / Protected apartments
Athens
The Guest House / Protected apartments
Spain2 sites, 2 recruiting
- Recruiting
General Directorate of Social Services, council of family, youth and social affairs, community of Madrid (DGSSI-CM)
Madrid
Noelia Mancebo Salas, 0034913925528, noelia.mancebo@madrid.org
- Recruiting
Servicio Madrileño de Salud (SERMAS)
Madrid
Rosa Gomez Trenado, 0034913700942, rgtrenado@salud.madrid.org
Poland1 site, 1 recruiting
- Recruiting
The Association of Youth and People with Mental Problems, Their Families and Friends POMOST
Lodz
Magdalena Wrzesińska, 0048693037010, magdalena.wrzesinska@umed.lodz.pl
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Patient Navigation
- Keywords
- Europe, Prevention, Cancer, Cancer prevention, Primary prevention, Mental health, Mental health problems, Patient Navigation, Implementation science, Co-design, Longitudinal, Person-centered
- Medical subject headings
- Neoplasms, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NavigationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| People with mental ill-health | Other | 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. Receives: Other: Patient Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
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 posted30 May 2024
- Study start24 Jun 2024
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1,240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Senior Europa Sociedad Limitada, Prolepsis Institute for Preventive, Environmental and Occupational Medicine, Universitat Politècnica de València, STICHTING INTERNATIONAL FOUNDATION FOR INTEGRATED CARE, Medical University of Lodz, Consejería de Familia, Juventud y Política Social, Comunidad de Madrid, Servicio Madrileño de Salud, Madrid, Spain, Fundacion para la Investigacion e Innovacion Biosanitaria de Atencion Primaria, Mental Health Europe - Sante Mentale Europe, University Mental Health Research Institute, Athens, Greece, 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
- 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
- NCT06435117
- Sponsor's protocol ID
- 101104784
- Acronym
- CO-CAPTAIN
- Status last verified
- May 2024
- First submitted
- 28 Mar 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Prevention Among Individuals with Mental Ill-health: Co-adapting and Implementing Patient Navigation for Primary Cancer Prevention
- ClinicalTrials.gov ID
- NCT06435117
- Acronym / sponsor ID
- CO-CAPTAIN / 101104784
- Conditions
- Cancer
- Keywords
- Europe, Prevention, Cancer, Cancer prevention, Primary prevention, Mental health, Mental health problems, Patient Navigation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,240 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Senior Europa Sociedad Limitada, Prolepsis Institute for Preventive, Environmental and Occupational Medicine, Universitat Politècnica de València, STICHTING INTERNATIONAL FOUNDATION FOR INTEGRATED CARE, Medical University of Lodz, Consejería de Familia, Juventud y Política Social, Comunidad de Madrid, Servicio Madrileño de Salud, Madrid, Spain, Fundacion para la Investigacion e Innovacion Biosanitaria de Atencion Primaria, Mental Health Europe - Sante Mentale Europe, University Mental Health Research Institute, Athens, Greece, 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
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 30 May 2024 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with mental ill-health | Other | Other: Patient NavigationAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Individuals unable to give consent due to diminished capacity
- Individuals who do not provide consent
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 |
|---|---|---|
| Patient NavigationCO-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. | Other | People with mental ill-health |
Primary outcome
Health data of participants as assessed by self-report or electronic health reports
Time frame: 18 months
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.
Nutritional intake of participants as assessed by the Rapid Prime Diet Quality Score Screener (rPDQS)
Time frame: 18 months
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).
Smoking behavior of participants as assessed by the Fagerström Test for Nicotine Dependence (FND)
Time frame: 18 months
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).
Physical activity of participants as assessed by the International Physical Activity Questionnaire (IPAQ)
Time frame: 18 months
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).
Depressive symptoms of participants as assessed by the Patient Health Questionnaire (PHQ-9)
Time frame: 18 months
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).
Generalized anxiety of participants as assessed by the 7-item anxiety scale (GAD-7)
Time frame: 18 months
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).
Health-related anxiety of participants as assessed by the Whiteley Index (Whiteley-6-R)
Time frame: 18 months
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).
(Health-related) Quality of life of participants as assessed by the World Health Organization Quality of Life Brief Version (WHO-QOL-BREF)
Time frame: 18 months
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).
(Health-related) Quality of life of participants as assessed by the descriptive system of the EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L)
Time frame: 18 months
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).
(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)
Time frame: 18 months
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).
Self-efficacy of participants as assessed by the General Self-Efficacy Scale (GSES)
Time frame: 18 months
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).
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)
Time frame: 18 months
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).
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)
Time frame: 18 months
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).
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)
Time frame: 18 months
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).
Social support as part of health literacy of participants as assessed by the Social support of health scale of the Health Literacy Questionnaire (HLQ)
Time frame: 18 months
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).
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)
Time frame: 18 months
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).
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)
Time frame: 18 months
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).
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)
Time frame: 18 months
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).
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)
Time frame: 18 months
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).
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)
Time frame: 18 months
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).
Use of healthcare services of participants as assessed by self-reports
Time frame: 18 months
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.
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
Time frame: 18 months
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).
Satisfaction with care of participants as assessed by self-reports and items from the Patient Satisfaction Questionnaire Short Form (PSQ-18)
Time frame: 18 months
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).
Discrimination experiences of participants as assessed by self-reports
Time frame: 18 months
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.
Facilitators of the Patient Navigation Model as experienced by participants and assessed by qualitative semi-structured interviews
Time frame: 18 months
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.
Barriers of the Patient Navigation Model as experienced by participants and assessed by qualitative semi-structured interviews
Time frame: 18 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- HORIZON EUROPELink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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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
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigation in people with Cancer, run by Medical University of Vienna at 9 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Austria, Greece, Spain, Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Igor Grabovac, MD, PhD (+43 1 40160 34897, igor.grabovac@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health data of participants as assessed by self-report or electronic health reports (time frame: 18 months). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2025.