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CLEAR-PC
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · EUROPEAN HEALTH AND DIGITAL EXECUTIVE AGENCY (HADEA)
observational
3,100
1 country
1
Study Start
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
March 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 14, 2026
Actual (reported)February 27, 2026
Actual (reported)March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
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).
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
University Miguel Hernández
Alicante, Spain
First Submitted
February 14, 2026
First Posted
February 27, 2026
Study Start
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Contact the study team to confirm eligibility.
March 2028
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 3, 2026
Record last verified: 2026-02
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Source: ClinicalTrials.gov.
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