PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: update to the study protocol for a randomized controlled trial
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
Affiliations
Anne-Laure Couderc
Service de Médecine Interne Gériatrie et Thérapeutique, CHU Sainte Marguerite, Assistance Publique des Hôpitaux de Marseille (AP-HM)
Emilie Nouguerède
Service de Médecine Interne Gériatrie et Thérapeutique, CHU Sainte Marguerite, Assistance Publique des Hôpitaux de Marseille (AP-HM)
Karine Baumstarck
EA3279, Self-perceived Health Assessment Research Unit, Aix-Marseille University
Sandrine Loubière
EA3279, Self-perceived Health Assessment Research Unit, Aix-Marseille University
Hervé Le Caer
Service de Pneumologie, CH Yves le Foll
Olivier Guillem
Unit of Coordination in Onco-Geriatry (UCOG)
Frédérique Rousseau
Unit of Coordination in Onco-Geriatry (UCOG)
Laurent Greillier
Unit of Coordination in Onco-Geriatry (UCOG)
Emmanuelle Norguet-Monnereau
Unit of Coordination in Onco-Geriatry (UCOG)
Maud Cecile
Unit of Coordination in Onco-Geriatry (UCOG)
Rabia Boulahssass
Service de Gérontologie, Hôpital de Cimiez
Françoise Le Caer
Unit of Coordination in Onco-Geriatry (UCOG)
Sandrine Tournier
Unit of Coordination in Onco-Geriatry (UCOG)
Chantal Butaud
Unit of Coordination in Onco-Geriatry (UCOG)
Pierre Guillet
Unit of Coordination in Onco-Geriatry (UCOG)
Sophie Nahon
Unit of Coordination in Onco-Geriatry (UCOG)
Sylvie Kirscher
Unit of Coordination in Onco-Geriatry (UCOG)
Nadine Diaz
Service Social, Hôpital Sainte Marguerite, AP-HM
Claire Morando
Direction de la Recherche Clinique et de l’Innovation (DRCI), AP-HM
Patrick Villani
Service de Médecine Interne Gériatrie et Thérapeutique, CHU Sainte Marguerite, Assistance Publique des Hôpitaux de Marseille (AP-HM)
Pascal Auquier
EA3279, Self-perceived Health Assessment Research Unit, Aix-Marseille University
Aurélie Daumas
Service de Médecine Interne Gériatrie et Thérapeutique, CHU Sainte Marguerite, Assistance Publique des Hôpitaux de Marseille (AP-HM)
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.
