International Study to Evaluate Two Programs of Support for Patients With Advanced Cancer and Their Families
The overall aim of this project is to evaluate the effectiveness, cost-effectiveness and mechanisms of action of two psychoeducational interventions (a face-to-face nurse-led intervention called FOCUS+ and an eHealth intervention called iFOCUS) aimed at improving the emotional function and self-efficacy of patients with advanced cancer and their family caregiver. Both interventions are compared to care as usual. Both interventions focus on teaching dyads optimal ways to jointly manage the implications of advanced cancer and responding to their priority concerns and are designed to be tailored to the specific needs and wishes of the patient-caregiver dyads. Tailoring is based on information about the dyad obtained at enrollment (e.g. age, relationship, etc.) and the responses in the intervention sessions. The overarching aim is addressed by five core intervention components: supporting family involvement and improving the dyads mutual communication, supporting outlook (i.e. increasing the dyad's capacity to identify positive or meaningful aspects related to their situation), increasing dyads' coping skills, i.e. their capacity to identify their coping strategies and take action help dyads reduce their uncertainty teaching symptom management and giving them confidence to handle specific tasks and problems Project objectives: To compare 1) the face-to-face FOCUS+ intervention and 2) the iFOCUS web intervention to 3) care as usual in terms of their: Effect on the emotional function and self-efficacy (primary outcomes), appraisal of illness, uncertainty, hopelessness, coping, dyad communication, quality of life and healthcare resource use of patients with advanced cancer and their family caregivers Cost-effectiveness Effects on vulnerable subgroups (particularly women and those of lower socioeconomic status) Effectiveness in different healthcare systems To evaluate the implementation process of the interventions in terms of the acceptability, feasibility, usefulness as perceived by patients, family caregivers and healthcare staff in each country, and their mechanisms of action. Data will be collected three times from patient-caregiver dyads: 1) baseline measure (t0) after which the dyad will immediately be randomized to one of the study arms, 2) first follow-up at 12 weeks after baseline (t1) and 3) second follow-up at 24 weeks after baseline (t2).
Start: February 2021