Evaluation of Dyadic Psychoeducational Interventions for People with Advanced Cancer and their Informal Caregivers (DIAdIC): An international randomized controlled trial

Despite the serious problems that advanced cancer involves for patients and
their family caregivers, there are few interventions that target both the
patient and the family caregiver to self-manage these problems. Dyadic
interventions, i.e. targeting the patient and family caregiver together, are
more likely to result in better outcomes for both parties than single target
interventions and are more cost-effective.
Consequently, interventions focusing on the quality of life of both the patient
and the family caregiver (i.e. the dyad) are necessary to promote their
well-being, reduce their burden and avoid unnecessary economic costs of
end-of-life cancer care.

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. These interventions are aimed at improving
the emotional function and self-efficacy of patients with advanced cancer and
their family caregivers.
Specific objectives:
(1) To compare the face-to-face FOCUS+ intervention and the iFOCUS web
intervention with care as usual in terms of their:
- Effect on the emotional functioning and self-efficacy of patients with
advanced cancer and their family caregivers (primary outcomes),
- Effect on participants appraisal of the illness, uncertainty,
hopelessness, coping, dyad communication, quality of life and healthcare
resource use
- Cost-effectiveness
- Effects on vulnerable subgroups (particularly women and those with a of lower
socioeconomic status)
- Effectiveness in different healthcare systems
(2) 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.

This study is an international multicenter three-arm randomized superiority
trial.

The face-to-face intervention: FOCUS+
Delivery mode and dose
This intervention will be provided to patient-caregiver dyads after they
completed the baseline measurement (T0) and were randomly allocated to the
face-to-face intervention. The face-to-face FOCUS+ intervention is a home-based
intervention consisting of two 90-minute home visits and one 30-minute
telephone session, conducted by a trained intervention nurse over a period of
12 weeks (4 weeks between each session).
The web-based intervention: iFOCUS
Delivery mode and dose
This intervention will be provided to patient-caregiver dyads after they
completed the baseline measurement (T0) and were randomly allocated to the web-
intervention. The web-based iFOCUS intervention is a self-managed
psycho-educational intervention that is completed autonomously by the
patient-caregiver dyads. It encompasses four sessions over a period of 12 weeks
(3 weeks between each session).

The DIAdIC protocol is non-invasive and does not involve known risks of
protocol-related injury. It is a psycho-educational intervention focused on the
provision of information; it is not intended to be a therapeutic or
cognitive/behavioral intervention.