Cancer Literacy Education and Awareness Resources for Prostate Care

NCT07437482 | Not Yet Recruiting

• 1 other identifier: 101219353
• Study Type: observational
• Target: 3,100
• Locations: 1 country
• Sites: 1

Brief Summary

The CLEAR-PC project addresses the critical issue of low health literacy in prostate cancer prevention and care, recognising that inadequate health literacy leads to difficulties in understanding complex medical information, limits shared decision making, and increases health inequalities. Given the high prevalence and complexity of prostate cancer, the project aims to design and development of a comprehensive strategy to improve health literacy in the Prostate cancer prevention and care, considering individual capacities, the role of healthcare professionals and organisations, and the influence of social and cultural contexts. In the design and development of this new strategy, the investigators apply both action research and cocreation methodologies because by involving all stakeholders (general population, vulnerable population patients, health professionals, policy makers and other target groups), we ensure that the resulting strategy is user-centred, implementable and responsive to their needs. The design and development of the new strategy will follow a systematic cycle: (a) problem diagnosis by assessing individual contexts, healthcare professionals, organisational aspects and the social framework; (b) adaptation of existing health literacy tools to the specific context of prostate cancer prevention and care, integrating them into a new strategy, followed by evaluation of their usability and acceptability; and (c) observation of results in practice and reflection. Co-creation will be a critical component throughout this process, ensuring that stakeholders are actively involved at every stage, from diagnosis of challenges to refinement and validation of solutions. The consortium, composed of institutions from Spain, Portugal, Croatia, Belgium, the Netherlands and Cyprus, leverages multidisciplinary expertise to create digital and non-innovative tools and educational resources to address public health disparities, reduce misinformation and support decision-making on prostate cancer prevention and care.

Conditions

Health Literacy; Prostate Cancer

Keywords

Prostate cancer; Health literacy; Diagnosis; Screening; Treatment; Palliative care

Outcome Measures

Primary Outcomes (1)

• Shared decision-making

  Implementation of shared decision-making between healthcare professionals and patients during prostate cancer screening, treatment decision-making, and palliative care consultations will be assessed using validated questionnaires: the Shared Decision-Making Questionnaire for patients (SDM-Q-9) and the Shared Decision-Making Questionnaire for physicians (SDM-Q-Doc). Scores from these instruments will be transformed to a 0-100 scale, with higher scores indicating greater levels of shared decision-making. Differences in SDM scores between the intervention group (use of the CLEAR-PC strategy) and the control group (usual care) will be analyzed. Units of Measurement: SDM-Q-9 and SDM-Q-Doc score (0-100 scale).

  Baseline (prior to implementation of the CLEAR-PC strategy) and immediately post-intervention (at completion of the pilot implementation phase).

Secondary Outcomes (4)

• Prostate cancer knowledge

  Baseline (prior to implementation of the CLEAR-PC strategy) and immediately post-intervention (at completion of the pilot implementation phase).

• Patient satisfaction with care

  Baseline (prior to implementation of the CLEAR-PC strategy) and immediately post-intervention (at completion of the pilot implementation phase).

• Emotional and psychological well-being

  Baseline (prior to implementation of the CLEAR-PC strategy) and immediately post-intervention (at completion of the pilot implementation phase).

• Usability and educational value of the CLEAR-PC strategy

  Baseline (prior to implementation of the CLEAR-PC strategy) and immediately post-intervention (at completion of the pilot implementation phase).

Study Arms (1)

Participants receiving the CLEAR-PC health literacy intervention

This cohort includes participants exposed to the CLEAR-PC intervention, a multilevel strategy designed to improve digital health literacy and shared decision-making in prostate cancer prevention and care. The intervention includes educational materials, decision aids, and communication resources tailored to prostate cancer screening, treatment decision-making, and palliative care. It also provides training and support resources for healthcare professionals to improve patient communication. The strategy is developed through co-creation with patients, clinicians, and stakeholders and considers social determinants of health, including the needs of vulnerable populations. The intervention may be delivered through digital platforms, printed materials, workshops, or clinical consultations, depending on the study setting, and is evaluated for its impact on patient understanding, confidence in decision-making, and communication outcomes.

Other: Co-created digital health literacy intervention for prostate cancer prevention and care

Interventions

Co-created digital health literacy intervention for prostate cancer prevention and care OTHER

This intervention differs from other prostate cancer education or decision-support programmes because it uses a multilevel approach, targeting patients, healthcare professionals, organisations, and the social context that influences health decisions. It is developed through co-creation and action-research, meaning that patients, caregivers, clinicians, and policy makers participate in designing and refining the tools to ensure usability and cultural relevance. The intervention combines digital and non-digital components, including decision aids, educational materials, and professional training specifically tailored to prostate cancer screening, treatment decision-making, and palliative care. It also explicitly considers social determinants of health and includes strategies for vulnerable populations to reduce inequalities. Finally, the strategy is piloted and evaluated in clinical practice to assess its impact on patient understanding, shared decision-making, and communication skills.

Participants receiving the CLEAR-PC health literacy intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be recruited from the general population, patients, caregivers, and healthcare professionals in participating European countries, including Spain, Portugal, Belgium, the Netherlands, and Croatia. The population will primarily include adults aged 40 years and older, reflecting the age group at risk for prostate cancer, as well as healthcare professionals involved in prostate cancer care and communication. Recruitment will take place through healthcare centres, patient organisations, community groups, and professional networks. The study will aim to include individuals from diverse socioeconomic, educational, and cultural backgrounds, including vulnerable populations such as migrants, minorities, and people with lower digital or health literacy levels, to ensure that the intervention is relevant and applicable across different social contexts.

You may qualify if:

• Adults aged 40 years or older
• Member of the general population, patient, caregiver, or healthcare professional eligible for the study component
• Able to understand and communicate in the language used at the study site
• Able to provide informed consent
• Willing to participate in surveys, interviews, workshops, or intervention activities as applicable
• Access to digital or non-digital materials required for the intervention, depending on study arm

You may not qualify if:

• Participation in another study that could interfere with the outcomes of this study

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead
• Canary Islands Health Service: collaborator
• Ordem dos Psicólogos: collaborator
• Thomas More University of Applied Sciences: collaborator
• Erasmus Medical Center: collaborator
• Center for Social Innovation: collaborator
• Europa UOMO: collaborator
• Universidad de Murcia: collaborator
• Fundación Canaria de Investigación Sanitaria: collaborator
• FEFOC fundation: collaborator
• Ministry of Health - Government of the Principality of Asturias: collaborator
• Asturias Public Health Service (SESPA): collaborator
• Fundacion para el Fomento en Asturias de la Investigacion Cientifica Aplicada y Tecnologia: collaborator
• Public Open University Čakovec: collaborator
• Instituto de Investigación Sanitaria y Biomédica de Alicante: collaborator
• Spanish Society of Family and Community Medicine: collaborator
• FISABIO (Foundation for the Promotion of Healthcare and Biomedical Research in the Valencian Community): collaborator

Study Sites (1)

University Miguel Hernández

Alicante, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Blanca Lumbreras, PhD

CONTACT

+34965919510; blumbreras@umh.es

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 14, 2026
• First Posted: February 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

ES (1)