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

delete2026-03-23
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Craig Gouldthorpe
A
Andrew Davies
DOI:10.1177/02692163261426431delete
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Abstract

Abstract

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<jats:sec> <jats:title>Background:</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Aim:</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Design:</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Settings/participants:</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Results:</jats:title> <jats:p> Participants ( <jats:italic toggle="yes">n</jats:italic>  = 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 ( <jats:italic toggle="yes">p</jats:italic>  = 0.003) and insomnia ( <jats:italic toggle="yes">p</jats:italic>  = 0.021), and symptom-related distress scores (all <jats:italic toggle="yes">p</jats:italic>  &lt; 0.01). Scores also improved for social ( <jats:italic toggle="yes">p</jats:italic>  = 0.001), cognitive ( <jats:italic toggle="yes">p</jats:italic>  = 0.006), emotional ( <jats:italic toggle="yes">p</jats:italic>  = 0.012), and physical ( <jats:italic toggle="yes">p</jats:italic>  = 0.046) functioning. </jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions:</jats:title> <jats:p>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.</jats:p> </jats:sec>
Keywords:
circadian rest-activity rhythm
advanced cancer
non-pharmacological intervention
feasibility study
cognitive behavioural therapy for insomnia

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Palliative Medicine cover
Palliative Medicine
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3.9
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trinity college dublin
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