FOCUSau: A Dyadic Digital Health Intervention to Improve the Wellbeing of People With Advanced Cancer and Their Carers

Summary

FOCUS is a dyadic, psychoeducational intervention developed in the USA, shown to improve the wellbeing and quality of life (QoL) of patients with advanced cancer and their primary family carers. The intervention consists of five core components underpinning the FOCUS acronym:

(F) supporting Family involvement, (O) supporting Outlook and meaning, (C) increasing Coping effectiveness, (U) reducing Uncertainty, and (S) Symptom management. Originally a nurse-delivered in-person intervention, FOCUS has been translated into a self-administered web-based intervention as part of an European study.

The overall aim of this project is to determine the effectiveness and sustainability of a digital health intervention (FOCUSau) aimed at improving the wellbeing and self-efficacy of patients with advanced cancer and their primary support person/carer.

A primary support person/carer is an unpaid individual identified by the person with advanced cancer (not necessarily a partner or family member) who is providing them with physical, social or emotional support. Hereafter referred to as a "carer". The term "dyad" refers to the patient and primary support person/carer.

The project objectives are:

1. adapt FOCUS to the Australian context and develop FOCUSau;
2. examine the effectiveness of FOCUSau in improving the wellbeing (primary outcomes: QoL and self-efficacy) of patients with advanced cancer and their primary family carer;
3. compare the type and costs of health service use by participants in the intervention and control group; and
4. assess the acceptability, feasibility and scalability of FOCUSau in order to inform sustainable implementation of the intervention within the Australian health care system.

A pragmatic phase III hybrid effectiveness-implementation trial with an integrated research design that includes digital health evaluation will be used in patients with advanced cancer and their primary support person/carer.

Data will be collected three times from patient-carer dyads:

1. at baseline (T0) after which the dyad will immediately be randomised 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).

Conditions

• Advanced Cancer

Interventions

BEHAVIORAL

FOCUSau

FOCUSau is a self-administered web-based intervention and completed autonomously via the internet by the dyad. Delivery encompasses the completion of four prescribed consecutive FOCUSau sessions (with three weeks between each session) over a period of 12 weeks. The sessions are completed simultaneously by the patient and family carer, together at a computer. The intervention sessions can be completed at any time within the 12-week timeframe. Participants receive tailored individual and dyadic messages according to the information provided at study enrollment and their responses to questions within the sessions. Dyads are also provided with an online personal workbook containing the results of interactive exercises completed during the internet sessions. Any information sheets that the dyad indicated as 'of interest to them' during the internet sessions are included as a hyperlink in their personal workbook which also contains evidence-based local advanced cancer related resources.

Sponsors & Collaborators

• St Vincent's Hospital Melbourne

  collaborator OTHER

• University of Technology, Sydney

  collaborator OTHER

• National Health and Medical Research Council, Australia

  collaborator OTHER

• University of Sydney

  collaborator OTHER

• Peter MacCallum Cancer Centre, Australia

  collaborator OTHER

• Vrije Universiteit Brussel

  collaborator OTHER

• Flinders University

  collaborator OTHER

• Queensland University of Technology

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• University of Melbourne

  lead OTHER

Principal Investigators

• Peter Hudson, PhD · The University of Melbourne and St Vincents Hospital Melbourne

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-31

Primary Completion

2025-08-31

Completion

2025-08-31

Countries

• Australia

Study Locations