Couderc Anne-Laure, Nouguerède Emilie, Baumstarck Karine, Loubière Sandrine, Le Caer Hervé, Guillem Olivier, Rousseau Frédérique, Greillier Laurent, Norguet-Monnereau Emmanuelle, Cecile Maud, Boulahssass Rabia, Le Caer Françoise, Tournier Sandrine, Butaud Chantal, Guillet Pierre, Nahon Sophie, Kirscher Sylvie, Diaz Nadine, Morando Claire, Villani Patrick, Auquier Pascal, Daumas Aurélie
Service 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.
Unit of Coordination in Onco-Geriatry (UCOG), PACA-west, France.
Trials. 2019 Jan 15;20(1):54. doi: 10.1186/s13063-018-3127-0.
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.
ClinicalTrials.gov, NCT02829762 . Registered on 29 June 2016.
社会隔离会增加老年癌症患者群体因癌症死亡的风险。PREDOMOS研究调查了建立一个与智能家居和远程协助技术相关的社会干预项目对改善老年孤立患者生活质量的影响，这些患者接受局部晚期或转移性癌症治疗。本文更新了试点试验方案。
ClinicalTrials.gov，NCT02829762。于2016年6月29日注册。
