PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: update to the study protocol for a randomized controlled trial

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.

Keywords: Cost effectiveness; Older patient, cancer; Oncogeriatrics; Randomized controlled trial; Social intervention program; Techniques of domotic and remote assistance.

Conflict of interest statement

Authors’ information

Not applicable.

Ethics approval and consent to participate

The study is conducted in accordance with the Helsinski declaration and the French laws and regulations (Code de la Santé Publique, article L.1121-1 / Loi de Santé Publique n°2004-806 du 9 août 2004 relative à la politique de santé publique et ses décrets d’application du 27 août 2006) and the International Conference on Harmonization (ICH) E6 Guideline for Good Clinical Practice. Regulatory monitoring will be performed by the sponsor. The sponsor needed the approval of the French authorities, including the French ethics committee (Comité de Protection des Personnes Sud Méditerranée I (CPPSM1)), version 2 of the PREDOMOS protocol submitted on march 23rd 2016 reference number 16 26 was approved on the 26th may 2016 for all 10 participating centers, the French drug and device regulation agency (Agence Nationale de Sécurité du Médicament (ANSM), registry number 2015-A01976-43) approved on the 29th June 2016, before beginning the study. Substantial changes to the protocol (revised version 4) was approved on May 29th 2018 by the ANSM and on June 25th 2018 by the CPPSM1. The ClinicalTrials.gov identifier is NCT02829762. Informed consent was obtained from all subjects.

Consent for publication

Informed consent was obtained from all subjects.

Competing interests

The authors declare that they have no competing interests.

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