title: PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: study protocol for a randomized controlled trial.
abstract: Cancer incidence and social isolation increase along with advanced age, and social isolation potentiates the relative risk of death by cancer. Once spotted, social isolation can be averted with the intervention of a multidisciplinary team. Techniques of automation and remote assistance have already demonstrated their positive impact on falls prevention and quality of life (QoL), though little is known about their impact on socially isolated elderly patients supported for cancer. The primary objective of the PREDOMOS study is to evaluate the impact of establishing a Program of Social intervention associated with techniques of Domotic and Remote assistance (PS-DR) on the improvement of QoL of elderly isolated patients, treated for locally advanced or metastatic cancer. The secondary objectives include treatment failure, tolerance, survival, and autonomy.
  
  
  
  This trial is a multicenter, prospective, randomized, placebo-controlled, open-label, two-parallel group study. The setting is 10 French oncogeriatric centers. Inclusion criteria are patients aged at least 70 years with a social isolation risk and a histological diagnosis of cancer, locally advanced or metastatic disease. The groups are (1) the control group, receiving usual care; (2) the experimental group, receiving usual care associating with monthly social assistance, domotic, and remote assistance. Participants are randomized in a 1:1 allocation ratio. Evaluation times involve inclusion (randomization) and follow-up (12 months). The primary endpoint is QoL at 3 months (via European Organization for Research and Treatment of Cancer (EORTC) QLQ C30); secondary endpoints are social isolation, time to treatment failure, toxicity, dose response-intensity, survival, autonomy, and QoL at 6 months. For the sample size, 320 individuals are required to obtain 90% power to detect a 10-point difference (standard deviation 25) in QoL score between the two groups (20% loss to follow-up patients expected).
  
  
  
  The randomized controlled design is the most appropriate design to demonstrate the efficacy of a new experimental strategy (Evidence-Based Medicine Working Group classification). National and international recommendations could be updated based on the findings of this study.
  
  
  
  ClinicalTrials.gov, NCT02829762 . Registered on 29 June 2016.
authors.affiliation: Unit of Transversal Onco-Geriatry (UTOG), Service de Médecine Interne et Gériatrie Thérapeutique, 264 Rue Saint Pierre, 13385, Marseille cedex 05, France.|Unit of Coordination in Onco-Geriatry (UCOG), PACA-west, Marseille, France.
authors.forename: Elodie
authors.initials: E
authors.lastname: Crétel-Durand
authors.affiliation: Unit of Transversal Onco-Geriatry (UTOG), Service de Médecine Interne et Gériatrie Thérapeutique, 264 Rue Saint Pierre, 13385, Marseille cedex 05, France. emilie.nouguerede@ap-hm.fr.|CRO2 UMR_S 911, INSERM, Aix-Marseille Université, 27 Boulevard Jean Moulin, 13385, Marseille cedex 05, France. emilie.nouguerede@ap-hm.fr.
authors.forename: Emilie
authors.identifier: http://orcid.org/0000-0003-3903-3267
authors.initials: E
authors.lastname: Nouguerède
authors.affiliation: Service de Pneumologie, CH Saint Brieuc - Hôpital Ives Le Foll, 10 Rue Marcel Proust, 22000, Saint Brieuc, France.
authors.forename: Hervé
authors.initials: H
authors.lastname: Le Caer
authors.affiliation: Unit of Coordination in Onco-Geriatry (UCOG), PACA-west, Marseille, France.|Service d'Oncologie Médicale, Institut Paoli Calmettes, 232 Boulevard de Sainte Marguerite Dromel, 13009, Marseille, France.
authors.forename: Frédérique
authors.initials: F
authors.lastname: Rousseau
authors.affiliation: Unit of Coordination in Onco-Geriatry (UCOG), PACA-west, Marseille, France.|Centre de Gérontologie Départemental, 176 Avenue de Montolivet, 13012, Marseille, France.
authors.forename: Frédérique
authors.initials: F
authors.lastname: Retornaz
authors.affiliation: Unit of Coordination in Onco-Geriatry (UCOG), PACA-west, Marseille, France.|Service d'Onco-Gériatrie, CH Intercommunal des Alpes du Sud Site de Gap (CHICAS), 1 Place Auguste Muret, 05000, Gap, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Guillem
authors.affiliation: Unit of Coordination in Onco-Geriatry (UCOG), PACA-west, Marseille, France.|Service de Médecine Interne et Gériatrie Thérapeutique, Hôpital Sainte Marguerite, Assistance Publique des Hôpitaux de Marseille (AP-HM), 270 Boulevard de Sainte Marguerite Dromel, 13274, Marseille cedex 09, France.
authors.forename: Anne-Laure
authors.initials: AL
authors.lastname: Couderc
authors.affiliation: Unit of Coordination in Onco-Geriatry (UCOG), PACA-west, Marseille, France.|Oncologie Multidisciplinaire et Innovation Thérapeutique, CHU NORD, Assistance Publique des Hôpitaux de Marseille (AP-HM), Chemin des Bourrely, 13915, Marseille cedex 20, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Greillier
authors.affiliation: Unit of Coordination in Onco-Geriatry (UCOG), PACA-west, Marseille, France.|Service d'Oncologie Digestive, CHU Timone, Assistance Publique des Hôpitaux de Marseille (AP-HM), 264 Rue Saint Pierre, 13385, Marseille cedex 05, France.
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Norguet
authors.affiliation: Unit of Coordination in Onco-Geriatry (UCOG), PACA-west, Marseille, France.|Service d'Oncologie Médicale, Institut Paoli Calmettes, 232 Boulevard de Sainte Marguerite Dromel, 13009, Marseille, France.
authors.forename: Maud
authors.initials: M
authors.lastname: Cécile
authors.affiliation: Service de Gérontologie, Hôpital de Cimiez, 4 Avenue Reine Victoria, CS 91179, 06003, Nice, France.
authors.forename: Rabia
authors.initials: R
authors.lastname: Boulahssass
authors.affiliation: Pôle de Gériatrie, CH Saint Brieuc, Hôpital Yves Le Foll, 10 Rue Marcel Proust, 22000, Saint Brieuc, France.
authors.forename: Francoise
authors.initials: F
authors.lastname: Le Caer
authors.affiliation: Unit of Coordination in Onco-Geriatry (UCOG), PACA-west, Marseille, France.|Service de Gériatrie, Hôpital Saint Joseph, 26 Boulevard Louvain, 13285, Marseille cedex 08, France.
authors.forename: Sandrine
authors.initials: S
authors.lastname: Tournier
authors.affiliation: Unit of Coordination in Onco-Geriatry (UCOG), PACA-west, Marseille, France.|Unité Mobile de Gériatrie, Hôpital Saint Musse, CH Intercommunal Toulon-La Seyne sur Mer (CHITS), 54 Rue Henri Claire Deville, 83000, Toulon, France.
authors.forename: Chantal
authors.initials: C
authors.lastname: Butaud
authors.affiliation: Unit of Coordination in Onco-Geriatry (UCOG), PACA-west, Marseille, France.|Unité Mobile de Gériatrie, Hôpital Saint Musse, CH Intercommunal Toulon-La Seyne sur Mer (CHITS), 54 Rue Henri Claire Deville, 83000, Toulon, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Guillet
authors.affiliation: Unit of Coordination in Onco-Geriatry (UCOG), PACA-west, Marseille, France.|Service d'Hémato-Oncologie, CH du Pays d'Aix, Avenue les Tamaris, 13616, Aix-en-Provence, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Nahon
authors.affiliation: Unit of Coordination in Onco-Geriatry (UCOG), PACA-west, Marseille, France.|Service d'Hémato-Oncologie, CH du Pays d'Aix, Avenue les Tamaris, 13616, Aix-en-Provence, France.
authors.forename: Laure
authors.initials: L
authors.lastname: Poudens
authors.affiliation: Unit of Coordination in Onco-Geriatry (UCOG), PACA-west, Marseille, France.|Service d'Oncologie Médicale, Institut Sainte Catherine (ISC), 250 Chemin de Baigne Pieds, 84918, Avignon cedex 09, France.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Kirscher
authors.affiliation: EA3279, Self-perceived Health Assessment Research Unit, Aix-Marseille University, 27 Boulevard Jean Moulin, 13385, Marseille cedex 05, France.
authors.forename: Sandrine
authors.initials: S
authors.lastname: Loubière
authors.affiliation: Service Social, Hôpital Sainte Marguerite, Assistance Publique des Hôpitaux de Marseille (AP-HM), 270 Boulevard de Sainte Marguerite Dromel, 13274, Marseille cedex 09, France.
authors.forename: Nadine
authors.initials: N
authors.lastname: Diaz
authors.affiliation: Direction de la Recherche Clinique et de l'Innovation (DRCI), Assistance Publique des Hôpitaux de Marseille (AP-HM), 80 Rue Brochier, 13354, Marseille Cedex 05, France.
authors.forename: Jean
authors.initials: J
authors.lastname: Dhorne
authors.affiliation: EA3279, Self-perceived Health Assessment Research Unit, Aix-Marseille University, 27 Boulevard Jean Moulin, 13385, Marseille cedex 05, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Auquier
authors.affiliation: EA3279, Self-perceived Health Assessment Research Unit, Aix-Marseille University, 27 Boulevard Jean Moulin, 13385, Marseille cedex 05, France.
authors.forename: Karine
authors.initials: K
authors.lastname: Baumstarck
mesh_terms: D000367:Age Factors; D000368:Aged; D000375:Aging / Q000523:psychology*; D002985:Clinical Protocols; D005260:Female; D005602:France; D006304:Health Status; D006792:House Calls; D006801:Humans; D008132:Loneliness; D008297:Male; D008603:Mental Health; D009369:Neoplasms / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D026684:Personal Autonomy; D011446:Prospective Studies; D011788:Quality of Life; D058998:Remote Sensing Technology; D012107:Research Design; D012934:Social Isolation; D000068217:Social Workers; D011795:Surveys and Questionnaires; D013689:Telephone; D013997:Time Factors; D016896:Treatment Outcome
keywords: Elderly cancer; Oncogeriatrics; Randomized controlled trial; Social intervention program; Techniques for domotic and remote assistance