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Open Access 01-12-2019 | Update

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

Authors: Anne-Laure Couderc, Emilie Nouguerède, Karine Baumstarck, Sandrine Loubière, Hervé Le Caer, Olivier Guillem, Frédérique Rousseau, Laurent Greillier, Emmanuelle Norguet-Monnereau, Maud Cecile, Rabia Boulahssass, Françoise Le Caer, Sandrine Tournier, Chantal Butaud, Pierre Guillet, Sophie Nahon, Sylvie Kirscher, Nadine Diaz, Claire Morando, Patrick Villani, Pascal Auquier, Aurélie Daumas

Published in: Trials | Issue 1/2019

Abstract

Background

Social isolation potentiates the risk of death by cancer in the older cancer patient population. The PREDOMOS study investigates the impact of establishing a Program of Social intervention associated with techniques of Domotic and Remote assistance on the improvement of quality of life of older isolated patients, treated for locally advanced or metastatic cancer. This paper updates the pilot trial protocol.

Methods/design

The original protocol was published in Trials, accessible at https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-1894-7.

This update reports on the eligibility criteria expansion and on the adjunction of a cost-utility analysis. We widened the eligible population to patients with locally advanced or metastatic cancer including malignant hemopathies (except acute myeloid leukemia) and to patients in the first and second lines of oncologic treatment. We restricted the inclusion to patients with a Mini Mental State Examination score strictly over 24. In addition to the secondary outcomes outlined in the protocol, a medico-economic analysis has been added to evaluate both the health benefits and costs of the two strategies and calculate the incremental cost-utility ratio of the innovative program assessed, compared to the standard practice.

Trial registration

ClinicalTrials.gov, NCT02829762. Registered on 29 June 2016.

Crétel-Durand E, Nouguerède E, Le Caer H, Rousseau F, Retornaz F, Guillem O, Couderc A-L, Greillier L, Norguet E, Cécile M, Boulahssass R, Le Caer F, Tournier S, Butaud C, Guillet P, Nahon S, Poudens L, Kirscher S, Loubière S, Diaz N, Dhorne J, Auquier P, Baumstarck K. PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: study protocol for a randomized controlled trial. Trials. 2017;18(1):174.CrossRef

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Title: PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: update to the study protocol for a randomized controlled trial
Authors: Anne-Laure Couderc
Emilie Nouguerède
Karine Baumstarck
Sandrine Loubière
Hervé Le Caer
Olivier Guillem
Frédérique Rousseau
Laurent Greillier
Emmanuelle Norguet-Monnereau
Maud Cecile
Rabia Boulahssass
Françoise Le Caer
Sandrine Tournier
Chantal Butaud
Pierre Guillet
Sophie Nahon
Sylvie Kirscher
Nadine Diaz
Claire Morando
Patrick Villani
Pascal Auquier
Aurélie Daumas
Publication date: 01-12-2019
Publisher: BioMed Central
Published in: Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-018-3127-0

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

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

Abstract

Background

Methods/design

Trial registration

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Background

Methods/design

Trial registration

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