Cancer Prevention Among Individuals with Mental Ill-health: Patient Navigation for Primary Cancer Prevention

NCT06435117 | Recruiting DMC

• 1 other identifier: 101104784
• Study Type: interventional
• Target: 1,240
• Locations: 4 countries
• Sites: 9

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.

Conditions

Cancer

Keywords

Europe; Prevention; Cancer; Cancer prevention; Primary prevention; Mental health; Mental health problems; Patient Navigation; Implementation science; Co-design; Longitudinal; Person-centered

Outcome Measures

Primary Outcomes (26)

• 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

Study Arms (1)

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.

Other: Patient Navigation

Interventions

Patient Navigation OTHER

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.

People with mental ill-health

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Individuals unable to give consent due to diminished capacity
• Individuals who do not provide consent

Sponsors & Collaborators

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

Study Sites (9)

Hietzing Hospital

Vienna, Austria

RECRUITING

LOGIN - Verein zur Gesundheitsförderung und sozialen Integration

Vienna, Austria

RECRUITING

Medical University of Vienna

Vienna, Austria

RECRUITING

Mental Health Clinic

Athens, Greece

RECRUITING

The Day Hospital

Athens, Greece

RECRUITING

The Guest House / Protected apartments

Athens, Greece

RECRUITING

The Association of Youth and People with Mental Problems, Their Families and Friends POMOST

Lodz, Poland

RECRUITING

General Directorate of Social Services, council of family, youth and social affairs, community of Madrid (DGSSI-CM)

Madrid, Spain

RECRUITING

Servicio Madrileño de Salud (SERMAS)

Madrid, Spain

RECRUITING

Related Links

• HORIZON EUROPE

MeSH Terms

Conditions

Neoplasms; Psychological Well-Being

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Igor Grabovac, MD, PhD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Igor Grabovac, MD, PhD

CONTACT

+43 1 40160 34897; igor.grabovac@meduniwien.ac.at

Hanna M. Mües, MSc

CONTACT

+43 1 40160 34662; hanna.muees@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project coordinator

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: May 30, 2024
• Study Start: June 24, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 19, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.
• Access Criteria: Upon request

Locations

ES (2); AU (3); GR (3); PL (1)