Abstract
Background: Insomnia is a distressing and an enduring problem that affects between 25 and 59% of cancer patients during and after treatments. Despite its association with reduced quality of life, negative psychological symptoms and cancer-related fatigue, this major concern remains insufficiently assessed and managed in routine care. Cognitive-Behavioural Therapy for Insomnia (CBT-I) is considered as the non-pharmalogical gold standard treatment. However, one main limitation is the practical implementation of the intervention because of the lack of trained professionals in cancer care settings and geographic distances from therapeutics resources. The frequent presence of somatic comorbidities, such as fatigue or pain, can also complicate access to care. New technologies open innovative ways to facilitate access to targeted interventions, such as online attractive and easy-to-use programs. Trial design: Designed as close as possible to the usual care conditions, the monocentric pilot study SLEEP-4-ALL-1 mains, first, to determine the feasibility of a systematic self-screening for insomnia in a population of 400 French adult cancer outpatients with breast, colorectal, pulmonary or urological cancer, using the Insomnia Severity Index (ISI); second, to evaluate among patients with insomnia the acceptability of an online video-based CBT-I, validated in a Quebec breast cancer survivors sample by Savard’s team, with a mixed method approach (quantitative and qualitative). Inclusions are currently completed. SLEEP-4-ALL-1 study, funded by the French National Institute of Cancer (INCA), corresponds to the development phase of a multicentric randomized controlled trial (SLEEP-4-ALL-2) which aims to test an online stepped-care model in the treatment of persistent insomnia, that can provide patients and health professionals an efficient, easily available, replicable, and cost-effective therapeutic solution. Legal entity responsible for the study: Gustave Roussy Cancer Center. Funding: French National Institute of Cancer (INCA): Interventional Research in Public Health Call. Disclosure: All authors have declared no conflicts of interest.
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