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.
