Abstract
BACKGROUND: Each year millions are diagnosed with cancer, impacting both patients and caregivers. Few interventions target both patients and family caregivers together, despite their shared experiences. While dyadic psychoeducational programs are gaining attention, evidence on developing and implementing these in international trials is limited. The DIAdIC trial faced unique challenges requiring innovative solutions to maintain study integrity. OBJECTIVES: To present our experiences with the development and implementation of two dyadic psychoeducational home-based programs, FOCUS+ and iFOCUS in the context of a randomized controlled trial (RCT) in six European countries. DESIGN: A case report detailing our experiences in the development and implementation of two dyadic psychoeducational home-based programs (one face-to-face and one web-based) across multiple countries, highlighting the challenges and mitigating strategies in an international context. METHODS: A chronological narrative describing experiences with the development and implementation of iFOCUS and FOCUS+. RESULTS: The FOCUS+ and iFOCUS programs were successfully developed for the European context through rigorous translation and adaptation processes. Despite recruitment challenges including COVID-19 restrictions and administrative hurdles, 431 patient-caregiver dyads were enrolled across 6 European countries. Quantitative and qualitative data assessed the outcomes of FOCUS+ and iFOCUS interventions, including the primary endpoints of emotional functioning and self-efficacy. Fidelity was evaluated using audio recordings, checklists, and user data. Challenges in trial management were addressed with flexible timelines and technical support. CONCLUSION: The international DIAdIC trial developed and implemented two psychoeducational dyadic programs for patients with advanced cancer and their family caregivers. Based on our experiences we share several insights for future similar studies. These relate to the attention needed for context-specific adaptations when using existing interventions or programs, the translation of human-facilitated programs to standalone eHealth versions, the challenges of adopting a dyadic focus in the study, the pragmatic challenges of conducting an RCT and evaluating implementation and effects, and the technology used for study management.