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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: study protocol for a randomized controlled trial

Authors: Elodie Crétel-Durand, Emilie Nouguerède, Hervé Le Caer, Frédérique Rousseau, Frédérique Retornaz, Olivier Guillem, Anne-Laure Couderc, Laurent Greillier, Emmanuelle Norguet, Maud Cécile, Rabia Boulahssass, Francoise Le Caer, Sandrine Tournier, Chantal Butaud, Pierre Guillet, Sophie Nahon, Laure Poudens, Sylvie Kirscher, Sandrine Loubière, Nadine Diaz, Jean Dhorne, Pascal Auquier, Karine Baumstarck

Published in: Trials | Issue 1/2017

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Abstract

Background

Cancer incidence and social isolation increase along with advanced age, and social isolation potentiates the relative risk of death by cancer. Once spotted, social isolation can be averted with the intervention of a multidisciplinary team. Techniques of automation and remote assistance have already demonstrated their positive impact on falls prevention and quality of life (QoL), though little is known about their impact on socially isolated elderly patients supported for cancer.
The primary objective of the PREDOMOS study is to evaluate the impact of establishing a Program of Social intervention associated with techniques of Domotic and Remote assistance (PS-DR) on the improvement of QoL of elderly isolated patients, treated for locally advanced or metastatic cancer. The secondary objectives include treatment failure, tolerance, survival, and autonomy.

Methods/design

This trial is a multicenter, prospective, randomized, placebo-controlled, open-label, two-parallel group study. The setting is 10 French oncogeriatric centers. Inclusion criteria are patients aged at least 70 years with a social isolation risk and a histological diagnosis of cancer, locally advanced or metastatic disease. The groups are (1) the control group, receiving usual care; (2) the experimental group, receiving usual care associating with monthly social assistance, domotic, and remote assistance. Participants are randomized in a 1:1 allocation ratio. Evaluation times involve inclusion (randomization) and follow-up (12 months). The primary endpoint is QoL at 3 months (via European Organization for Research and Treatment of Cancer (EORTC) QLQ C30); secondary endpoints are social isolation, time to treatment failure, toxicity, dose response-intensity, survival, autonomy, and QoL at 6 months. For the sample size, 320 individuals are required to obtain 90% power to detect a 10-point difference (standard deviation 25) in QoL score between the two groups (20% loss to follow-up patients expected).

Discussion

The randomized controlled design is the most appropriate design to demonstrate the efficacy of a new experimental strategy (Evidence-Based Medicine Working Group classification). National and international recommendations could be updated based on the findings of this study.

Trial registration

ClinicalTrials.gov, NCT02829762. Registered on 29 June 2016.
Appendix
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Metadata
Title
PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: study protocol for a randomized controlled trial
Authors
Elodie Crétel-Durand
Emilie Nouguerède
Hervé Le Caer
Frédérique Rousseau
Frédérique Retornaz
Olivier Guillem
Anne-Laure Couderc
Laurent Greillier
Emmanuelle Norguet
Maud Cécile
Rabia Boulahssass
Francoise Le Caer
Sandrine Tournier
Chantal Butaud
Pierre Guillet
Sophie Nahon
Laure Poudens
Sylvie Kirscher
Sandrine Loubière
Nadine Diaz
Jean Dhorne
Pascal Auquier
Karine Baumstarck
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1894-7

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