International Study to Evaluate Two Programs of Support for Patients With Advanced Cancer and Their Families

Summary

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:

1. supporting family involvement and improving the dyads mutual communication,
2. supporting outlook (i.e. increasing the dyad's capacity to identify positive or meaningful aspects related to their situation),
3. increasing dyads' coping skills, i.e. their capacity to identify their coping strategies and take action
4. help dyads reduce their uncertainty
5. teaching symptom management and giving them confidence to handle specific tasks and problems

Project objectives:

1. 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
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.

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).

Conditions

• Advanced Cancer

Interventions

OTHER

FOCUS+ (face-to-face nurse-led intervention)

Home-based psycho-educational intervention consisting of two 90-minute home visits and one 30-minute video-conferencing session, conducted by a trained intervention nurse over a period of 12 weeks (4 weeks between each session). The intervention is comprehensively manualized and there is a protocol to guide delivery of the intervention for each home visit and video call. The content of the sessions is always tailored to the needs of the dyads, so certain topics can be discussed more in-depth and specific information can be shared. The nurses who will deliver the FOCUS+ intervention will receive an extensive online training and additional continuous follow-up training to provide them with the knowledge and skills required to successfully implement the intervention. A FOCUS+ core booklet is provided as a supporting guide for the dyads that they can refer to at their own discretion and reinforces key intervention messages linked to the core components of the intervention.

OTHER

iFOCUS (web-based intervention)

Self-managed psycho-educational intervention that is completed autonomously by the patient-caregiver dyads together. It encompasses four sessions (with three weeks between each session) over a period of 12 weeks. The sessions are completed simultaneously by the patient and the family caregiver, sitting side by side at a computer. Patient-caregiver dyads have flexibility as to when they want to complete the intervention session. Based on the information patients and caregivers provided at enrollment and during the web-based sessions, they receive tailored individual and dyadic messages. An online personal workbook is provided containing the results of the interactive exercises that are provided to the dyads during the web-sessions. Any information brochures, leaflets and information sheets that the dyad indicated as 'of interest to them' during the web-sessions will be included as a hyperlink in their personal workbook.

Sponsors & Collaborators

• Erasmus Medical Center

  collaborator OTHER

• King's College London

  collaborator OTHER

• Queen's University, Belfast

  collaborator OTHER

• University Ghent

  collaborator OTHER

• University of Copenhagen

  collaborator OTHER

• University of Dublin, Trinity College

  collaborator OTHER

• University College Dublin

  collaborator OTHER

• Azienda USL di Reggio Emilia

  collaborator UNKNOWN

• European Commission

  collaborator OTHER

• Vrije Universiteit Brussel

  lead OTHER

Principal Investigators

• Joachim Cohen, MSc, PhD · Vrije Universiteit Brussel

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-24

Primary Completion

2023-09-30

Completion

2023-11-30

Countries

• Belgium
• Denmark
• Ireland
• Italy
• Netherlands
• United Kingdom

Study Locations