NCT06082128

Brief 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. 1.adapt FOCUS to the Australian context and develop FOCUSau;
  2. 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. 3.compare the type and costs of health service use by participants in the intervention and control group; and
  4. 4.assess the acceptability, feasibility and scalability of FOCUSau in order to inform sustainable implementation of the intervention within the Australian health care system.
  5. 5.at baseline (T0) after which the dyad will immediately be randomised to one of the study arms,
  6. 6.first follow-up at 12 weeks after baseline (T1) and,
  7. 7.second follow-up at 24 weeks after baseline (T2).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
433

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

1.7 years

First QC Date

September 20, 2023

Last Update Submit

October 8, 2023

Conditions

Advanced Cancer

Keywords

Palliative careEnd-of-life decision makingSupportive carePsychoeducational interventionDyadicFamily caregiverQuality of life

Outcome Measures

Primary Outcomes (2)

  • Change in emotional wellbeing

    For patients and for carers: The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) 10 emotional function items

    T0 (baseline), T1 (12 weeks) and T2 (24 weeks)

  • Change in self-efficacy

    For patients and for carers: The Lewis´ Cancer self-efficacy scale

    T0 (baseline), T1 (12 weeks) and T2 (24 weeks)

Secondary Outcomes (12)

  • Change in patient quality of life

    T0 (baseline), T1 (12 weeks) and T2 (24 weeks)

  • Change in carer quality of life

    T0 (baseline), T1 (12 weeks) and T2 (24 weeks)

  • Change in patient social wellbeing

    T0 (baseline), T1 (12 weeks) and T2 (24 weeks)

  • Change in patient social functioning

    T0 (baseline), T1 (12 weeks) and T2 (24 weeks)

  • Change in patient overall health

    T0 (baseline), T1 (12 weeks) and T2 (24 weeks)

  • +7 more secondary outcomes

Study Arms (2)

Usual care

NO INTERVENTION

Dyads in the control group will receive usual care only. Usual advanced cancer care is known to be heterogeneous. It is expected usual care to include care from specialists, doctors, nurses or other health care professionals that patients usually engage with.

FOCUSau

EXPERIMENTAL

Dyads in the FOCUSau arm will receive the web-based FOCUSau program in addition to usual care.

Behavioral: FOCUSau

Interventions

FOCUSauBEHAVIORAL

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.

Also known as: Family involvement(F),Supporting outlook and meaning(O),Increasing Coping Effectiveness(C),Reducing Uncertainty(U),Symptom Management(S), FOCUSau (web-based intervention)
FOCUSau

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of advanced cancer
  • Over 18 years of age
  • Able to comprehend written or spoken English
  • No visual, hearing, and/or cognitive impairment that would preclude participation
  • Able to commit to research participation requirements (including data collection and completion of the FOCUSau intervention if randomised to that group)
  • Able to access the internet (on desktop computer, laptop computer or tablet device)
  • Able to identify a primary support person/carer, who is an unpaid individual (not necessarily a partner or family member) who is providing physical, social or emotional support.

You may not qualify if:

  • \- Involvement in an advanced cancer non-drug trial that focuses on improving QoL
  • Identified by the patient as their primary support person who is related to them biologically, legally or emotionally, and is willing to accept this support role
  • Aged over 18 years
  • No visual, hearing, and/or cognitive impairment that would preclude participation
  • Able to commit to research participation requirements
  • Able to access the internet
  • \- Capacity to effectively utilise the internet (as determined through a short practical online exercise as part of the screening and consent process).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Calvary Healthcare Kogarah

Kogarah, New South Wales, 2217, Australia

Location

Mater Health Service

Kangaroo Point, Queensland, 4169, Australia

Location

Northern Adelaide Palliative Service

Modbury, South Australia, 5092, Australia

Location

Barwoon Health Mckellar Centre

Geelong, Victoria, 3215, Australia

Location

St Vincents Hospital

Melbourne, Victoria, 3010, Australia

Location

Related Publications (1)

  • Hudson P, Francis J, Cohen J, Kapp S, De Abreu Lourenco R, Beatty L, Gray K, Jefford M, Juraskova I, Northouse L, de Vleminck A, Chang S, Yates P, Athan S, Baptista S, Klaic M, Philip J. Improving the Well-Being of People With Advanced Cancer and Their Family Caregivers: Protocol for an Effectiveness-Implementation Trial of a Dyadic Digital Health Intervention (FOCUSau). JMIR Res Protoc. 2024 Aug 13;13:e55252. doi: 10.2196/55252.

    PMID: 39137414DERIVED

Study Officials

  • Peter Hudson, PhD

    The University of Melbourne and St Vincents Hospital Melbourne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaira Baptista, PhD

CONTACT

+61394160000shaira.baptista@unimelb.edu.au

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the intervention the dyads cannot be blinded to allocation. The research nurse/officers involved in the consenting process will not be blinded as they will facilitate the second videoconference to inform the dyads about their allocated group (intervention or control). As data collection will occur electronically (via the FOCUSau platform) the research team will be blinded to which trial group the dyads were randomised to.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2023

First Posted

October 13, 2023

Study Start

December 1, 2023

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

October 13, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Results will be published in peer-reviewed, international journals. Local and International conference presentations are anticipated. Opportunities for sharing the study results via media will be sought (e.g., social media platforms such as Twitter). An option will be provided to participants to receive a plain language summary of the study results. We will use this plain language summary to provide the study results to relevant consumer networks including the Victorian Comprehensive Cancer Centre and Cancer Voices Australia.

Locations

AU(5)