Cancer Literacy Education and Awareness Resources for Prostate Care (CLEAR-PC)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer; Health Literacy
• Intervention / Treatment: Other: Co-created digital health literacy intervention for prostate cancer prevention and care

Detailed Description

Introduction Prostate cancer is one of the most common cancers in men worldwide and in Europe. Many men face difficult decisions about screening, diagnosis, treatment, and long-term care. These decisions often involve complex information, uncertainty about risks and benefits, and emotional stress.

At the same time, many people struggle to understand medical information or to assess whether information found online is reliable. This difficulty is known as limited health literacy-the ability to find, understand, evaluate, and use health information to make decisions. Today, health literacy also includes digital health literacy, which refers to the skills needed to use digital tools, websites, and online resources related to health.

Low levels of health literacy can lead to delayed diagnosis, misunderstanding of treatment options, reduced participation in shared decision-making with healthcare professionals, and inequalities in health outcomes. These challenges can be especially serious in prostate cancer, where decisions are complex and often depend on personal values and preferences.

The CLEAR-PC project was created to address this challenge by developing a comprehensive strategy to improve health literacy and digital health literacy related to prostate cancer prevention, diagnosis, treatment decisions, and palliative care. The study aims to help patients, caregivers, healthcare professionals, and the general public better understand prostate cancer and participate actively in decisions about care.

Overall aim of the study

The main goal of CLEAR-PC is to design, develop, and evaluate a strategy that improves health literacy and digital health literacy in prostate cancer care. This strategy will help people:

Access reliable and understandable information Understand risks and benefits of screening and treatment Participate in shared decision-making with healthcare professionals Reduce misinformation and confusion Improve communication between patients and clinicians Reduce inequalities in access to information and care

To achieve this, the project uses a multi-level approach that addresses:

Individuals and the information they receive Healthcare professionals and healthcare organizations Social, cultural, and environmental factors that influence health decisions

Participants in the study include:

Members of the general population Patients with prostate cancer Caregivers and family members Healthcare professionals (such as doctors, nurses, and psychologists) Researchers and educators Policy makers and health authorities Vulnerable or underserved populations The inclusion of diverse participants helps ensure that the tools and materials developed are practical, inclusive, and relevant to real-world needs.

Procedure CLEAR-PC follows an action-research and co-creation approach. Action research means that researchers do not only study a problem-they actively work with stakeholders to develop and test solutions in real settings. Co-creation means that patients, healthcare professionals, and other stakeholders participate in designing tools and strategies from the beginning, ensuring that the results are useful and easy to apply in practice.

The project progresses through three main phases.

Phase 1: Understanding needs and identifying gaps.

The first phase focuses on understanding current levels of health literacy and identifying barriers to informed decision-making. Researchers collect information using several methods:

Surveys: Large surveys are conducted among adults in several European countries to assess:

Knowledge about prostate cancer Ability to understand health information Use of digital health resources Confidence in making health decisions These surveys help identify gaps in knowledge and skills and show which groups may need additional support.

Focus groups: Group discussions are organized with:

Patients Caregivers Healthcare professionals Members of the general population People from vulnerable or minority communities These discussions provide insights into real experiences, challenges, and information needs.

Interviews Researchers also interview experts and policy makers to understand how health literacy can be improved at the healthcare system level.

Review of existing tools and programs: The project reviews existing educational materials, digital tools, and training programs used in Europe and internationally to improve health literacy. This helps identify best practices and areas that need improvement.

At the end of this phase, researchers have a clear picture of:

Current levels of knowledge and digital skills Barriers to understanding health information Needs of patients and professionals Existing resources that can be adapted

Phase 2: Designing and developing solutions In the second phase, researchers and stakeholders work together to design new tools and educational resources.

These may include:

Decision aids that help patients understand treatment options Educational videos and fact sheets Training programs for healthcare professionals Communication tools to explain risks and benefits clearly Digital platforms and online resources Community awareness materials These tools are tested in workshops and adapted to ensure they are understandable, culturally appropriate, and practical for different healthcare settings.

The aim is to create a CLEAR-PC strategy, a structured set of tools, materials, and best practices that can be used in real healthcare environments.

Phase 3: Testing the strategy in practice

Once the tools are developed, they are tested in clinical settings. This phase evaluates:

Whether patients better understand their condition Whether healthcare professionals communicate more effectively Whether patients feel more confident in making decisions Whether shared decision-making improves The results of this phase help refine the strategy before broader implementation.

Expected results

The study aims to produce several important outcomes:

Reliable and accessible educational materials about prostate cancer Training programs for healthcare professionals Tools that support shared decision-making Policy recommendations to improve communication and patient support A digital library of resources Strategies to combat misinformation

In the short term, the project will improve awareness and professional training. In the medium term, it will improve decision-making and communication. In the long term, it aims to reduce inequalities and improve health outcomes.

• Study Type: Observational
• Enrollment (Estimated): 3100

Contacts and Locations

• Study Contact: Name: Blanca Lumbreras, PhD; Phone Number: +34965919510; Email: blumbreras@umh.es

Study Locations

• Spain
  • Alicante, Spain
    • University Miguel Hernández

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prostate cancer knowledge	Change in patient knowledge regarding prostate cancer screening, diagnosis, and treatment will be assessed using the Prostate Cancer Knowledge Questionnaire (PCKQ-12). The questionnaire evaluates knowledge about symptoms, risk factors, screening recommendations, diagnosis, and treatment side effects. Higher scores indicate greater knowledge of prostate cancer. Units of Measurement: PCKQ-12 total score (0-12 points).	Baseline (prior to implementation of the CLEAR-PC strategy) and immediately post-intervention (at completion of the pilot implementation phase).
Patient satisfaction with care	Patient satisfaction with healthcare communication and consultation will be measured using the Patient Satisfaction Questionnaire (PSQ-18). This instrument evaluates satisfaction across several domains including communication, technical quality, and accessibility of care. Higher scores indicate greater satisfaction with care. finalproposal Units of Measurement: PSQ-18 score (Likert scale; total or domain scores).	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	Emotional distress related to prostate cancer screening, diagnosis, or treatment will be assessed using the Emotional Distress Thermometer (EDT). This tool measures patients' perceived distress related to their health condition and care process. Higher scores indicate greater emotional distress. finalproposal Units of Measurement: Distress score (0-10 scale).	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	Healthcare professionals and patients will provide feedback on the usability, educational usefulness, and communication support of the CLEAR-PC strategy through an ad-hoc questionnaire developed for the study. This will evaluate how easy the strategy is to use and its perceived usefulness in improving communication and understanding during consultations. finalproposal Units of Measurement: Likert-scale questionnaire scores.	Baseline (prior to implementation of the CLEAR-PC strategy) and immediately post-intervention (at completion of the pilot implementation phase).

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: February 14, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 28, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Treatment; Palliative care; Prostate cancer; Screening; Diagnosis; Health literacy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Pathological Conditions, Signs and Symptoms; Prostatic Neoplasms; Disease
• Other Study ID Numbers: 101219353 (Other Grant/Funding Number: EUROPEAN HEALTH AND DIGITAL EXECUTIVE AGENCY (HADEA))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No