@article{8733995,
  abstract     = {{Background: Worldwide, millions of people with advanced cancer and their family caregivers are experiencing physical and psychological distress. Psychosocial support and education can reduce distress and prevent avoidable healthcare resource use. To date, we lack knowledge from large-scale studies on which interventions generate positive outcomes for people with cancer and their informal caregivers' quality of life. This protocol describes the DIAdIC study that will evaluate the effectiveness of two psychosocial and educational interventions aimed at improving patient-family caregiver dyads' emotional functioning and self-efficacy. 

Methods: We will conduct an international multicenter three-arm randomized controlled trial in Belgium, Denmark, Ireland, Italy, The Netherlands, and the United Kingdom. In each country, 156 dyads (936 in total) of people with advanced cancer and their family caregiver will be randomized to one of the study arms: 1) a nurse-led faceto-face intervention (FOCUS+), 2) a web-based intervention (iFOCUS) or 3) a control group (care as usual). The two interventions offer tailored psychoeducational support for patient-family caregiver dyads. The nurse-led face-to-face intervention consists of two home visits and one online video session and the web-based intervention is completed independently by the patient-family caregiver dyad in four online sessions. The interventions are based on the FOCUS intervention, developed in the USA, that addresses five core components: family involvement, optimistic outlook, coping effectiveness, uncertainty reduction, and symptom management. The FOCUS intervention will be adapted to the European context. The primary outcomes are emotional functioning and self-efficacy of the patient and the family caregiver, respectively. The secondary outcomes are quality of life, benefits of illness, coping, dyadic communication, and ways of giving support of the patient and family caregiver. 

Discussion: DIAdIC aims to develop cost-effective interventions that integrate principles of early palliative care into standard care. The cross-country setup in six European countries allows for comparison of effectiveness of the interventions in different healthcare systems across Europe. By focusing on empowerment of the person with cancer and their family caregiver, the results of this RCT can contribute to the search for cost-effective novel interventions that can relieve constraints on professional healthcare.}},
  articleno    = {{193}},
  author       = {{Matthys, Orphé and De Vleminck, Aline and Dierickx, Sigrid and Deliens, Luc and Van Goethem, Vincent and Lapeire, Lore and Groenvold, Mogens and Lund, Line and Arnfeldt, Caroline Moeller and Sengeloev, Lisa and Pappot, Helle and Johnsen, Anna Thit and Guerin, Suzanne and Larkin, Philip J. and Jordan, Catherine and Connolly, Michael and D’Alton, Paul and Costantini, Massimo and Di Leo, Silvia and Guberti, Monica and Turola, Elena and van der Heide, Agnes and Witkamp, Erika and Rietjens, Judith and van der Wel, Maaike and Brazil, Kevin and Prue, Gillian and Reid, Joanne and Scott, David and Bristowe, Katherine and Harding, Richard and Normand, Charles and May, Peter and Cronin, Catherine and Northouse, Laurel and Hudson, Peter and Cohen, Joachim}},
  issn         = {{1472-684X}},
  journal      = {{BMC PALLIATIVE CARE}},
  keywords     = {{General Medicine,Psychoeducational intervention,Dyadic,cancer,Family caregiver,Randomized clinical trial,QUALITY-OF-LIFE,ITEM BANK,INSTRUMENT,VERSION,VALIDATION,WOMEN}},
  language     = {{eng}},
  number       = {{1}},
  pages        = {{18}},
  title        = {{Effectiveness of a nurse-delivered (FOCUS+) and a web-based (iFOCUS) psychoeducational intervention for people with advanced cancer and their family caregivers (DIAdIC) : study protocol for an international randomized controlled trial}},
  url          = {{http://doi.org/10.1186/s12904-021-00895-z}},
  volume       = {{20}},
  year         = {{2021}},
}

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