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

NACompletedINTERVENTIONAL
Enrollment

431

Participants

Timeline

Start Date

February 24, 2021

Primary Completion Date

September 30, 2023

Study Completion Date

November 30, 2023

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."

Trial Locations (13)

Unknown

AZ Maria Middelares, Ghent

AZ Sint-Lucas, Ghent

Universitair Ziekenhuis Gent, Ghent

AZ Damiaan, Ostend

Herlev University Hospital, Copenhagen

Rigshospitalet University Hospital, Copenhagen

St. Vincent's University Hospital, Dublin

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

Amphia Hospital, Breda

Reinier de Graaf Hospital, Delft

Belfast Trust, City Hospital, Belfast

Guy's and St Thomas' Hospitals NHS Foundation Trust, London

King's College Hospital NHS Foundation, London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Erasmus Medical Center

OTHER

collaborator

King's College London

OTHER

collaborator

Queen's University, Belfast

OTHER

collaborator

University Ghent

OTHER

collaborator

University of Copenhagen

OTHER

collaborator

University of Dublin, Trinity College

OTHER

collaborator

University College Dublin

OTHER

collaborator

Azienda USL di Reggio Emilia

UNKNOWN

collaborator

European Commission

OTHER

lead

Vrije Universiteit Brussel

OTHER