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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Effectiveness of an intervention to improve supportive care for family caregivers of patients with lung cancer: study protocol for a randomized controlled trial

Authors: Michèle Aubin, Lucie Vézina, René Verreault, Sébastien Simard, Jean-François Desbiens, Lise Tremblay, Serge Dumont, Lise Fillion, Maman Joyce Dogba, Pierre Gagnon

Published in: Trials | Issue 1/2017

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Abstract

Background

Family caregivers (FC) often experience higher distress levels than their relative with cancer. Many cancer centers have implemented distress screening programs, but most of them concentrate their efforts on patients, with little attention to their FC. To fill this gap, a pragmatic intervention has been designed to improve supportive care for FC of patients with lung cancer. This article describes the study protocol of a single-center randomized controlled trial to assess its effectiveness.

Methods/design

A total of 120 lung cancer patients and their FC are randomly assigned to the experimental group (exposed to intervention, N = 60) or to the control group (usual care, N = 60). The intervention includes: (1) systematic FC distress screening and problem assessment near their relative’s cancer diagnosis, and every 2 months, (2) privileged contact with an oncology nurse (ON) away from the patient to address FC problems and (3) liaison by the ON with the family physician of FC reporting high distress (thermometer score ≥5/10), or problems relying on FP expertise. In both groups, FC, patient and process-of-care outcomes are measured at baseline and every 3 months, up to 9 months. The primary endpoint is FC distress measured by the Hospital Anxiety and Depression Scale (HADS) and the Psychological Distress Index used in the Quebec Health Survey (PDQHS). Individual interviews with 10 FC and a focus group with the oncology team will be conducted at the study end to further document the effectiveness of the intervention and its impact on quality of life (for FC) and practice organization (for the oncology team).

Discussion

This trial will assess the effectiveness of an innovative intervention based on interprofessional collaboration between primary care and oncology care. It targets a population in great need, yet often neglected, and has the potential to clearly improve patient and caregiver experience of cancer care, and reduce the burden of disease.

Trial registration

ClinicalTrials.gov, ID: NCT02531464. Registered on 15 July 2015.
Appendix
Available only for authorised users
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Metadata
Title
Effectiveness of an intervention to improve supportive care for family caregivers of patients with lung cancer: study protocol for a randomized controlled trial
Authors
Michèle Aubin
Lucie Vézina
René Verreault
Sébastien Simard
Jean-François Desbiens
Lise Tremblay
Serge Dumont
Lise Fillion
Maman Joyce Dogba
Pierre Gagnon
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2044-y

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