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

NCT04626349 | Completed DMC

• 1 other identifier: EU grant agreement No 825722
• Study Type: interventional
• Target: 431
• Locations: 6 countries
• Sites: 13

Brief 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:

• 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
• 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.

Conditions

Advanced Cancer

Keywords

psychoeducational intervention; quality of life; self-efficacy; randomized clinical trial; oncology; family caregiver

Outcome Measures

Primary Outcomes (2)

• Change in emotional functioning

  For patients and for caregivers: EORTC 10 emotional function items

  T1 (baseline + 12 weeks)

• Change in self-efficacy

  For patients and for caregivers: the Lewis´ Cancer self-efficacy scale

  T1 (baseline + 12 weeks)

Secondary Outcomes (13)

• Change in emotional functioning

  T2 (baseline + 24 weeks)

• Change in self-efficacy

  T2 (baseline + 24 weeks)

• Change in patient quality of life

  T1 (baseline + 12 weeks), T2 (baseline + 24 weeks)

• Change in caregiver quality of life

  T1 (baseline + 12 weeks), T2 (baseline + 24 weeks)

• Change in patient social well-being

  T1 (baseline + 12 weeks), T2 (baseline + 24 weeks)

Study Arms (3)

FOCUS+

EXPERIMENTAL

Dyads in the FOCUS+ arm will receive the face-to-face nurse-led FOCUS+ program.

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

iFOCUS

EXPERIMENTAL

Dyads in the iFOCUS arm will receive the web-based iFOCUS program.

Other: iFOCUS (web-based intervention)

Standard care

NO INTERVENTION

Dyads in the control group will receive standard care as usual, as determined by the healthcare system in the participating countries. The dose and frequency of usual care will be as deemed appropriate by the medical practitioner in charge of their treatment.

Interventions

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

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.

FOCUS+

iFOCUS (web-based intervention) OTHER

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.

iFOCUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of cancer: solid organ (lung, colorectal, breast, prostate and other)
• No longer receives curative treatment (only life-prolonging or palliative treatments)
• Written informed consent
• Lives within feasible distance for intervention nurses to travel

You may not qualify if:

• Brain cancer, non-solid cancers
• Prognosis of less than 3 months
• Has no informal caregivers
• \< 18 years old
• Unable to participate in available languages
• FAMILY CAREGIVER
• Written informed consent
• Primary informal caregiver as determined by the patient
• Lives within feasible distance for intervention nurses to travel
• Unable to physically or mentally participate
• Cancer diagnosis in the last 12 months
• \<18 years old
• Unable to participate in available languages
• DYAD
• Patient and/or family caregivers has access to and is familiar with use of internet

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• Erasmus Medical Center: collaborator
• King's College London: collaborator
• Queen's University, Belfast: collaborator
• University Ghent: collaborator
• University of Copenhagen: collaborator
• University of Dublin, Trinity College: collaborator
• University College Dublin: collaborator
• Azienda USL di Reggio Emilia: collaborator
• European Commission: collaborator

Study Sites (13)

AZ Maria Middelares

Ghent, Belgium

Location

AZ Sint-Lucas

Ghent, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, Belgium

Location

AZ Damiaan

Ostend, Belgium

Location

Herlev University Hospital

Copenhagen, Denmark

Location

Rigshospitalet University Hospital

Copenhagen, Denmark

Location

St. Vincent's University Hospital

Dublin, Ireland

Location

Azienda USL-IRCCS di Reggio Emilia - Presidio ospedaliero provinciale sede di Reggio Emilia

Reggio Emilia, Italy

Location

Amphia Hospital

Breda, Netherlands

Location

Reinier de Graaf Hospital

Delft, Netherlands

Location

Belfast Trust, City Hospital

Belfast, United Kingdom

Location

Guy's and St Thomas' Hospitals NHS Foundation Trust

London, United Kingdom

Location

King's College Hospital NHS Foundation

London, United Kingdom

Location

Related Publications (7)

• Northouse LL, Mood DW, Schafenacker A, Kalemkerian G, Zalupski M, LoRusso P, Hayes DF, Hussain M, Ruckdeschel J, Fendrick AM, Trask PC, Ronis DL, Kershaw T. Randomized clinical trial of a brief and extensive dyadic intervention for advanced cancer patients and their family caregivers. Psychooncology. 2013 Mar;22(3):555-63. doi: 10.1002/pon.3036. Epub 2012 Jan 31.

  PMID: 22290823 BACKGROUND

• Northouse L, Schafenacker A, Barr KL, Katapodi M, Yoon H, Brittain K, Song L, Ronis DL, An L. A tailored Web-based psychoeducational intervention for cancer patients and their family caregivers. Cancer Nurs. 2014 Sep-Oct;37(5):321-30. doi: 10.1097/NCC.0000000000000159.

  PMID: 24945270 BACKGROUND

• Northouse L, Kershaw T, Mood D, Schafenacker A. Effects of a family intervention on the quality of life of women with recurrent breast cancer and their family caregivers. Psychooncology. 2005 Jun;14(6):478-91. doi: 10.1002/pon.871.

  PMID: 15599947 BACKGROUND

• Larkin PJ, Dierckx de Casterle B, Schotsmans P. Multilingual translation issues in qualitative research: reflections on a metaphorical process. Qual Health Res. 2007 Apr;17(4):468-76. doi: 10.1177/1049732307299258.

  PMID: 17416700 BACKGROUND

• May P, Smith S, Jallow M, Kalinjuna T, De Vlemnick A, Matthys O, Van Goethem V, Groenvold M, Guerin S, Turola E, Bakker E, Brazil K, Harding R, Northouse L, Hudson P, Cohen J, Charles N; DIAdIC consortium. Assessing the cost-effectiveness of two psychoeducational interventions for people with cancer and their caregivers: An economic evaluation of the multi-country DIAdIC trial. Contemp Clin Trials. 2026 Jan 21:108240. doi: 10.1016/j.cct.2026.108240. Online ahead of print.

  PMID: 41577124 DERIVED

• De Vleminck A, Matthys O, Turola E, Dierickx S, Dombrecht L, Van Goethem V, Deliens L, Lapeire L, Hudson P, Eecloo K, Brazil K, Groenvold M, Di Leo S, van der Heide A, Normand C, Harding R, Pilch M, Northouse L; DIAdIC Team; Cohen J. Impact of a nurse-led and a web-based psychoeducational program for advanced cancer patients and their caregivers: Results of a three-arm randomized controlled trial. Int J Nurs Stud. 2025 Nov;171:105192. doi: 10.1016/j.ijnurstu.2025.105192. Epub 2025 Aug 19.

  PMID: 40925214 DERIVED

• Matthys O, De Vleminck A, Dierickx S, Deliens L, Van Goethem V, Lapeire L, Groenvold M, Lund L, Arnfeldt CM, Sengeloev L, Pappot H, Johnsen AT, Guerin S, Larkin PJ, Jordan C, Connolly M, D'Alton P, Costantini M, Di Leo S, Guberti M, Turola E, van der Heide A, Witkamp E, Rietjens J, van der Wel M, Brazil K, Prue G, Reid J, Scott D, Bristowe K, Harding R, Normand C, May P, Cronin C, Northouse L, Hudson P, Cohen J. Effectiveness of a nurse-delivered (FOCUS+) and a web-based (iFOCUS) psychoeducational intervention for people with advanced cancer and their family caregivers (DIAdIC): study protocol for an international randomized controlled trial. BMC Palliat Care. 2021 Dec 28;20(1):193. doi: 10.1186/s12904-021-00895-z.

  PMID: 34963453 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Joachim Cohen, MSc, PhD

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention neither the patient-caregiver dyads nor the intervention nurses (for the face-to-face FOCUS+ intervention) can be blinded to allocation. Data will be collected via a computer-assisted self-interview with a data collector that is present for assistance and additional explanations. Those conducting the data analyses will be unaware as to what trial arm dyads were randomized to until the end of the last data collection point.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Public Health and Palliative Care

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 12, 2020
• Study Start: February 24, 2021
• Primary Completion: September 30, 2023
• Study Completion: November 30, 2023
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1); BE (4); DK (2); NL (2); IT (1); GB (3)