REstoring Sleep and Energy using a mulTimodal non-pharmacological intervention in advanced Cancer: A feasibility study (RESET-C).

Abstract

Circadian rest-activity rhythm disorders, affecting up to 60% of patients with advanced cancer, are associated with poor clinical outcomes. As disease severity correlates with circadian disruption, a multi-modal approach may be necessary to improve circadian rhythmicity in this population. To assess the feasibility, primarily in relation to recruitment, retention, usability and acceptability, of a multi-modal, non-pharmacological intervention in patients with advanced cancer and a circadian rest-activity rhythm disorder. A prospective, single arm, outpatient feasibility study took place over 8-weeks incorporating a clinical review, daily bright light therapy, online cognitive behavioural therapy for insomnia course, and personalised physical activity plan. Adult (⩾18 years old) outpatients from an acute hospital and hospice service with locally advanced or metastatic cancer and a circadian rest-activity rhythm disorder. Participants (<i>n</i> = 20) completed questionnaires (80%) and accelerometry (75%) and engaged with the CBT-I course (100%), bright light therapy (80%) and physical activity plan (100%). Participants reported acceptability and usability of the intervention, with no intervention-related adverse events noted. Preliminary improvements were seen in scores for fatigue (<i>p</i> = 0.003) and insomnia (<i>p</i> = 0.021), and symptom-related distress scores (all <i>p</i> < 0.01). Scores also improved for social (<i>p</i> = 0.001), cognitive (<i>p</i> = 0.006), emotional (<i>p</i> = 0.012), and physical (<i>p</i> = 0.046) functioning. The study demonstrated acceptability, usability and preliminary efficacy for the intervention, and warrants further investigation with a definitive trial to assess the impact on clinical outcomes of interest.