Periodic Reporting for period 1 - INSPIRE (INtegrated Short-term PallIative REhabilitation to improve quality of life and equitable care access in incurable cancer)
Periodo di rendicontazione: 2022-09-01 al 2024-02-29
Cancer is a major and growing contributor to disability (loss of function). Palliative rehabilitation empowers people with incurable conditions to actively manage their condition, enabling them to live fully and enjoy the best quality of life possible, including towards the end of life. It aims to reduce symptoms and help individuals stay independent and socially active.
Disability related to incurable cancer affects over a million Europeans each year. Our objective is to test the clinical and cost effectiveness of an integrated short-term palliative rehabilitation intervention to improve function and quality of life in individuals affected by incurable cancer.
At the core of INSPIRE is a multinational randomised controlled trial conducted across five European countries (UK, France, Italy, Denmark, and Norway). Should the results be positive, the trial could result in a scalable and equitable intervention that improves function and quality of life in people with incurable cancer while reducing the burden of care for their families. The intervention can be adapted and integrated into various health systems using existing staff and services, with minimal or no additional cost.
The INSPIRE consortium brings together leading experts in palliative care, oncology, and rehabilitation from Nordic, Southern, and Northern European countries, offering complementary expertise in applied and health services research, complex intervention trials, mixed-method evaluations, statistics, and health economics. We have established partnerships with European civil society organisations to ensure citizen engagement and dissemination at the highest level.
Disability related to incurable cancer affects over a million Europeans each year. Our objective is to test the clinical and cost effectiveness of an integrated short-term palliative rehabilitation intervention to improve function and quality of life in individuals affected by incurable cancer.
At the core of INSPIRE is a multinational randomised controlled trial conducted across five European countries (UK, France, Italy, Denmark, and Norway). Should the results be positive, the trial could result in a scalable and equitable intervention that improves function and quality of life in people with incurable cancer while reducing the burden of care for their families. The intervention can be adapted and integrated into various health systems using existing staff and services, with minimal or no additional cost.
The INSPIRE consortium brings together leading experts in palliative care, oncology, and rehabilitation from Nordic, Southern, and Northern European countries, offering complementary expertise in applied and health services research, complex intervention trials, mixed-method evaluations, statistics, and health economics. We have established partnerships with European civil society organisations to ensure citizen engagement and dissemination at the highest level.
Sparse knowledge exists on how rehabilitation is integrated into cancer and palliative care services across various healthcare systems in Europe. The initial work of the project involved a comparative analysis of healthcare services to inform the INSPIRE consortium about the understanding of the concept of palliative rehabilitation in cancer and its integration into clinical practice within and across INSPIRE partnership countries. The objectives of this work were to compare and report on similarities and variabilities in palliative cancer rehabilitation structure and provision, both cross-country and within-country, in the partnership trial countries. The INSPIRE trial was designed, and the ethic submission packages were prepared (including the protocol and informed consent) for submission to local ethical committees in the UK, France, Italy, Denmark, and Norway.
The trial was designed to assess, over an 8-week period, the clinical effectiveness of the INSPIRE palliative rehabilitation intervention on quality of life, disability, symptom burden, and goal attainment for patients with incurable cancer. Data collection to determine the cost-utility was also implemented in the protocol, along with the assessment of the identification of the barriers and facilitators to enable future integration of the intervention into clinical routines (e.g. acceptability, appropriateness, fidelity, feasibility, and sustainability of the intervention viewed by patients and healthcare professionals). Collaboration agreements between KCL and the involved trial centres were prepared, circulated, and signed. Submissions to the local ethical committees of the participating countries were conducted.
The Intervention Manual was prepared and translated for each country, along with all necessary training resources to educate and support rehabilitation practitioners across multiple sites. An emphasis was placed on how to conduct and assess an equitable inclusion recruitment strategy during the training sessions and site initiation visits (a template was provided at each inclusion site to identify baseline and socio-demographic characteristics, as well as patients’ personal and cultural beliefs).
The INSPIRE visual identity was created, and the project website was launched. The dissemination and exploitation plan was set up, and various dissemination actions were conducted by the consortium (such as blog posts, oral presentations, lectures, and open access publications).
The main trial includes setting up and conducting a randomised single-blind multicentre trial. The first step included developing the trial protocol and the ethics submission package that met ethical standards across all the participating countries.
The trial was designed to assess, over an 8-week period, the clinical effectiveness of the INSPIRE palliative rehabilitation intervention on quality of life, disability, symptom burden, and goal attainment for patients with incurable cancer. Data collection to determine the cost-utility was also implemented in the protocol, along with the assessment of the identification of the barriers and facilitators to enable future integration of the intervention into clinical routines (e.g. acceptability, appropriateness, fidelity, feasibility, and sustainability of the intervention viewed by patients and healthcare professionals). Collaboration agreements between KCL and the involved trial centres were prepared, circulated, and signed. Submissions to the local ethical committees of the participating countries were conducted.
The Intervention Manual was prepared and translated for each country, along with all necessary training resources to educate and support rehabilitation practitioners across multiple sites. An emphasis was placed on how to conduct and assess an equitable inclusion recruitment strategy during the training sessions and site initiation visits (a template was provided at each inclusion site to identify baseline and socio-demographic characteristics, as well as patients’ personal and cultural beliefs).
The INSPIRE visual identity was created, and the project website was launched. The dissemination and exploitation plan was set up, and various dissemination actions were conducted by the consortium (such as blog posts, oral presentations, lectures, and open access publications).
The main trial includes setting up and conducting a randomised single-blind multicentre trial. The first step included developing the trial protocol and the ethics submission package that met ethical standards across all the participating countries.
Our comparative health service analysis found limited integration of palliative rehabilitation and cancer across official documents and clinical practice, particularly in secondary healthcare settings. The unclear distinctions between palliative rehabilitation and palliative care in cancer, lack of funding, absence in care pathways, and competence deficiencies are all barriers to more widespread uptake and integration of rehabilitation. Evidence-based tailored interventions that align with individual patient needs and goals are urgently needed.