Periodic Reporting for period 3 - DIAdIC (Evaluation of Dyadic Psychoeducational Interventions for People with Advanced Cancer and their Informal Caregivers (DIAdIC): An international randomized controlled trial)
Periodo di rendicontazione: 2022-01-01 al 2023-06-30
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 problems
The 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 systems
2. To evaluate the implementation process of both interventions.
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 problems
The 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 systems
2. To evaluate the implementation process of both interventions.
Work carried out during 3 reporting periods towards the achievement of the objectives:
-Extended the duration of the project until 30/06/24
-Issued a protocol for the country-specific adaptations of the FOCUS Intervention materials from the original USA intervention
-Developed and culturally adapted the FOCUS intervention materials for the 6 European countries
-Developed a training programme for the intervention nurses to deliver the FOCUS+ intervention in their own countries and modified it into an e-learning programme
-Employed a ‘Community of Practice’ model: transnational and national online meetings of the nurses to enhance fidelity and quality of the program delivery, and Issued recommendations for implementation of an e-learning training across different European countries
-Developed a digital platform & eHealth tool for the web-based intervention - the web-DIAdIC program (iFOCUS)
-Published a manuscript, describing the development and testing of iFOCUS, in an open access peer reviewed journal
-Translated the questionnaires for dyads into the respective languages and conducted their testing with dyads in five of the 6 participating countries
-Completed and published the study protocol in an international peer-reviewed open access journal
-Completed the recruitment to the DIAdIC RCT
-Developed a cost-effectiveness data collection and analysis plan for cost-effectiveness evaluation and resource utilization
-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 in view of the analyses about country differences. Based on its results, a background report was written
-Completed a protocol for the process and implementation procedure including satisfaction surveys to be implemented in all countries. This served as a basis for a manuscript about process evaluation
-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 data
-Conducted qualitative interviews with nurses and participating dyads as part of the process evaluation
-Created a project website, social media accounts, explanatory videos, newsletters, e-blogs, presented the DIAdIC project at international and national congresses, etc
-Developed an Australian DIAdIC iFOCUS spin-off project: “FOCUSau”
-and more
-Extended the duration of the project until 30/06/24
-Issued a protocol for the country-specific adaptations of the FOCUS Intervention materials from the original USA intervention
-Developed and culturally adapted the FOCUS intervention materials for the 6 European countries
-Developed a training programme for the intervention nurses to deliver the FOCUS+ intervention in their own countries and modified it into an e-learning programme
-Employed a ‘Community of Practice’ model: transnational and national online meetings of the nurses to enhance fidelity and quality of the program delivery, and Issued recommendations for implementation of an e-learning training across different European countries
-Developed a digital platform & eHealth tool for the web-based intervention - the web-DIAdIC program (iFOCUS)
-Published a manuscript, describing the development and testing of iFOCUS, in an open access peer reviewed journal
-Translated the questionnaires for dyads into the respective languages and conducted their testing with dyads in five of the 6 participating countries
-Completed and published the study protocol in an international peer-reviewed open access journal
-Completed the recruitment to the DIAdIC RCT
-Developed a cost-effectiveness data collection and analysis plan for cost-effectiveness evaluation and resource utilization
-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 in view of the analyses about country differences. Based on its results, a background report was written
-Completed a protocol for the process and implementation procedure including satisfaction surveys to be implemented in all countries. This served as a basis for a manuscript about process evaluation
-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 data
-Conducted qualitative interviews with nurses and participating dyads as part of the process evaluation
-Created a project website, social media accounts, explanatory videos, newsletters, e-blogs, presented the DIAdIC project at international and national congresses, etc
-Developed an Australian DIAdIC iFOCUS spin-off project: “FOCUSau”
-and more
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.
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.