An RCT evaluation of two psycho-educational programs for cancer dyads
Research type
Research Study
Full title
An International Randomized Controlled Trial to evaluate the effectiveness of a nurse-delivered (FOCUS+) and a web-based (iFOCUS) psychoeducational intervention for people with Advanced cancer and their family caregivers.
IRAS ID
283434
Contact name
Kevin Brazil
Contact email
Sponsor organisation
Queen's University
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 10 months, 31 days
Research summary
Background. Advanced cancer affects millions of Europeans each year. The provision of adequate and cost-effective psychosocial and educational support for both patients and their frequently overburdened family caregivers is highly relevant from an economic, a healthcare and a prevention perspective.
Study aim. The DIAdIC project is an interdisciplinary, cross-national project designed to evaluate the effectiveness and cost-effectiveness of two psycho-educational dyadic interventions, i.e. interventions that target both the patient and family caregiver together. One intervention is a self-directed online e-health intervention while the other is a nurse-led intervention which will be delivered face-to-face with the dyad or via video conferencing software. Secondary aims are to assess the interventions' effects on vulnerable subgroups (e.g. people from a lower socioeconomic background), their effectiveness in different healthcare systems, and their suitability as perceived by end-users.
Design. The two interventions are tailored to the dyads' needs and have 5 core components: (1) supporting family involvement, (2) reducing hopelessness, (3) increasing coping effectiveness, (4) reducing uncertainty and (5) teaching symptom management. They are based on existing interventions, developed in the USA, that have been shown to improve quality of life in both the patient and their family caregiver.
Study outcomes. We propose to examine the effectiveness of each of the interventions (compared to usual care) by carrying out an international randomised controlled trial in people with advanced cancer and their primary family carer (this application is for the UK study sites only). The project includes a full health-economic evaluation and a thorough process evaluation. The project will advance our knowledge in several ways, e.g. by providing innovative healthcare interventions (including an eHealth solution) that embrace the philosophy and principles of early palliative care. The interventions will be suitable for implementation across diverse healthcare systems. Public involvement methods ensure the input of stakeholders throughout the project.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
21/YH/0006
Date of REC Opinion
7 Jan 2021
REC opinion
Favourable Opinion