Abstract
BackgroundCancer 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.Methods/designThis 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).DiscussionThe 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.Trial registrationClinicalTrials.gov, NCT02829762. Registered on 29 June 2016.
Highlights
Cancer incidence and social isolation increase along with advanced age, and social isolation potentiates the relative risk of death by cancer
The randomized controlled design is the most appropriate design to demonstrate the efficacy of a new experimental strategy (Evidence-Based Medicine Working Group classification)
To date, no randomized study has determined the impact of a social intervention associated with domotic and remote assistance techniques on the quality of life (QoL) of elderly patients being treated for locally advanced or metastatic cancer
Summary
No randomized study has determined the impact of a social intervention associated with domotic and remote assistance techniques on the QoL of elderly patients being treated for locally advanced or metastatic cancer. Its analysis allows a broader assessment of disease and treatment impact on the physical, mental, and social health of the elderly patient, considering his environment, his expectations, and his experience [34,35,36] These considerations motivated our choice of primary endpoint: QoL at 3 months, as it allows us to take into account the limited life expectancy of patients with locally advanced or metastatic tumors, including lung and pancreatic cancer. The PS-DR setup is less expensive than unplanned hospitalization or admission in a support care facility, installation of a home automation system for the 160 patients of the exposed arm has a cost To meet both clinical and financial requirements, it has been decided that the intervention would last 6 months (end of the first line of treatment for most locally advanced or metastatic cancers), at the end of which each domotic care package will be uninstalled.
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