PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: update to the study protocol for ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2019-12

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

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. More... »

PAGES

54

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s13063-018-3127-0

DOI

http://dx.doi.org/10.1186/s13063-018-3127-0

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1111429418

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30646923


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290 Unit of Coordination in Onco-Geriatry (UCOG), PACA-west, France
291 rdf:type schema:Organization
292 https://www.grid.ac/institutes/grid.5399.6 schema:alternateName Aix-Marseille University
293 schema:name EA3279, Self-perceived Health Assessment Research Unit, Aix-Marseille University, 27 Boulevard Jean Moulin, 13385, Marseille, cedex 05, France
294 rdf:type schema:Organization
 




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