Cancer Literacy Education and Awareness Resources for Prostate Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,100
- 试验地点
- 1
- 主要终点
- Shared decision-making
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Participation in another study that could interfere with the outcomes of this study
研究组 & 干预措施
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.
干预措施: Co-created digital health literacy intervention for prostate cancer prevention and care (Other)
结局指标
主要结局
Shared decision-making
时间窗: 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).
次要结局
- 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).)
研究者
Blanca Juana Lumbreras Lacarra
Principal Investigator
Universidad Miguel Hernandez de Elche