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PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: update to the
Anne-Laure Couderc1,2, Emilie Nouguerède3,4, Karine Baumstarck5
1Service de Médecine Interne Gériatrie et Thérapeutique, CHU Sainte Marguerite, Assistance Publique des Hôpitaux de Marseille (AP-HM), 270 Boulevard de Sainte Marguerite Dromel, 13274, Marseille, cedex 09, France.
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.
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