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Starting soon Observational

Cancer Literacy Education and Awareness Resources for Prostate Care

NCT07437482 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2026-03
Last updated
2026-03-03

Condition(s) studied

Health LiteracyProstate Cancer

Investigational drug(s) / intervention(s)

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

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

Study 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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * 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 Exclusion Criteria: * Participation in another study that could interfere with the outcomes of this study

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
University Miguel Hernández Alicante Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07437482 on ClinicalTrials.gov ↗ ← All trials in Spain