Periodic Reporting for period 2 - DIAdIC (Evaluation of Dyadic Psychoeducational Interventions for People with Advanced Cancer and their Informal Caregivers (DIAdIC): An international randomized controlled trial) Reporting period: 2020-07-01 to 2021-12-31 Summary of the context and overall objectives of the project In Europe, millions of people are newly diagnosed with cancer each year. In addition to physical symptoms people with cancer often also experience psychological, social, and spiritual consequences of their illness. Family caregivers are also impacted by a cancer diagnosis. Family caregivers are people who have a personal connection to the patient; they may be a friend, partner, ex-partner, sibling, parent, child or other. Often they have a double role: as provider of healthcare to the person with cancer, but also as a person in need of support for themselves. Much like the person with cancer family caregivers can experience psychological, social and physical consequences as a result of their caregiving role.In summary cancer impacts the quality of life both the person with the cancer and their family caregiver(s).Research indicates that both are better helped if support is offered to both the person with cancer and their primary (or main) family caregiver together (sometimes referred to as a dyad). Research also shows that we need new ways to improve support for people with cancer along with their family caregiver. That is why we are conducting a new project called the DIAdIC study. DIAdIC is a research project involving six European countries; Belgium, Denmark, Italy, Ireland, The Netherlands and the United Kingdom. The project will test and evaluate two types of support strategies to persons with cancer and their family caregivers:A first intervention is called FOCUS+ and is a nurse-led person-to-person approach. A specially trained nurse will have three extensive consultations over a course of 3 months with the patient-caregiver dyad. This intervention will usually take place in the home of the person with cancer and/or the family caregiver. The second strategy is called iFOCUS. In this approach the person with cancer and the family caregiver access four online (web based) sessions together via a computer program over a period of 3 months. The two FOCUS strategies have a different mode of delivery, but address the same five core components: Supporting family involvement and improving mutual communication Supporting outlook and meaning Increasing coping effectiveness Reducing uncertainty Teaching symptom management and giving confidence to handle specific tasks and problemsThe project’s scientific objectives are:1. 1.a) to evaluate whether the FOCUS+ and iFOCUS strategies increase the quality of life and self-efficacy of both the person with cancer and their family caregivers. 1.b) To evaluate the cost-effectiveness of both approaches and its impact on the use of professional health care resources. 1.c) To evaluate whether the strategies have different effects on different vulnerable groups and in different healthcare systems2. To evaluate the implementation process of both interventions. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far Within the 1st and 2nd reporting periods the DIAdIC consortium has achieved the following:1. Issued a protocol for the country-specific adaptations of the FOCUS Intervention materials from the original USA intervention2. Developed, reviewed, and culturally adapted the FOCUS intervention materials for the 6 European countries3. Developed an online training programme for intervention nurses who are delivering the FOCUS+ intervention in their own countries4. Developed a digital platform & eHealth tool for the web-based intervention - the web-DIAdIC program (iFOCUS) and performed user testings5. Selected the best instruments to measure the relevant outcomes, translated these into 5 languages and conducted the testing of the translated questionnaires with patients from the target group and their family caregivers in each country. This resulted in the final questionnaires for patients and family caregivers. 6. Obtained ethics approval to conduct the DIAdIC Randomized Controlled Trial (RCT) in all 6 participating countries7. Completed the study protocol for the Randomized controlled trial (RCT) study and published it in open access8. Commenced the main DIAdIC Randomized Controlled Trial (RCT) in all 6 participating countries9. Written a cost-effectiveness data collection and analysis plan detailing the patient and caregiver outcomes, and resource utilization10. Commenced a process of an explorative literature search and qualitative semi-structured interviews to understand current family caregiving practices and cultures in the participating countries. Based on the results of the literature search and semi-structured interviews in each country, a background report of current family caregiving practices and cultures in participating countries was written11. Completed a protocol for the process and implementation procedure including satisfaction surveys to be implemented in all countries12. Developed Interview schedules for a series of qualitative, semi-structured interviews that form a core component of the data collection for the Process Evaluation. Transcription guidelines were also developed to support data collection, an analysis plan was developed for the collected data13. Published a press release14. Developed and submitted a comprehensive Dissemination, Exploitation and Communication plan15. Created a project website, social media accounts; issued newsletters, recorded and disseminated DIAdIC project explanatory videos, written e-blogs, participated in a webinar and EAPC World Congresses16. And more Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) The DIAdIC project will advance the current state-of-the-art in several ways:1) The international design will inform policy across Europe. The effectiveness and cost-effectiveness of the interventions may be influenced by certain characteristics of healthcare systems. This knowledge will enable the study results to be more easily translated to a broader international context. 2) The DIAdIC project would be the first cross-national randomized controlled trial to focus significantly on experiences and quality of life of both people with advanced cancer and their family caregivers along with data on service use and cost.3) The conceptual model evaluated in the DIAdIC project will result in a scientifically innovative evidence based-model for future research in palliative care. It considers the influence of health care system factors, differences between patient categories (eg age, gender and socio-economic position) and dyads’ individual variation in needs and preferences.4) We will ensure that stakeholder knowledge and the input of end-users is incorporated throughout the project and, as such assess the suitability of the interventions and the data collection methods to the cultural and healthcare context of each country.5) Our project will make available an eHealth tool to provide psychosocial and educational support to both patient and family caregiver, tailored to each dyad’s needs. If successful, this tool will be available for immediate implementation in a number of European countries, where no similar tools currently exist. By studying the effectiveness of this tool we improve on the state-of-the-art by providing evidence for the use of eHealth solutions in healthcare.6) To maximally translate the findings into the practice setting, the project will draw on an evidence-based model of knowledge transfer and exchange (KTE) that has been developed to successfully facilitate the implementation of research results into health services.