Cancer Literacy Education and Awareness Resources for Prostate Care

ConditionsHealth Literacy Prostate Cancer

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age40+

SponsorUniversidad Miguel Hernandez de Elche

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

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

Treatment groups

3,100 Participants

are divided into 1 treatment group

Group A: Participants receiving the CLEAR-PC health literacy intervention1 intervention

Trial outcomes

Primary outcomes

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).

Time frame