The Sleepio after cancer (SAC) study. Digital cognitive behavioural therapy for insomnia (dCBT-I) in women cancer patients - Trial protocol of a randomised controlled trial

Aims: This study will assess the efficacy of digital CBT for insomnia (dCBT-I) compared to sleep hygiene education (SHE) for the management of insomnia in women with cancer.Background: 30% of patients with cancer meet insomnia diagnostic criteria and this can be detrimental to health outcomes. Insomnia disorder comprises a dissatisfaction with sleep quantity or quality characterized by difficulty initiating sleep, frequent awakenings, or early morning wakening without the ability to return to sleep, at least 3 nights per week, for at least 3 months, causing significant impairment or distress in areas of functioning.Methods: We will recruit 308 women with a current or prior cancer diagnosis who are currently experiencing insomnia; defined as a score of 16 or less on the Sleep Condition Indicator (SCI). Participants will be randomised to dCBT-I or SHE. dCBT-I will be delivered online via 6 sessions. SHE will be provided in an online format. Assessments of sleep and other related parameters, through validated questionnaires, will be taken at 12 and 24 weeks following intervention. Once 24 week assessments are completed, participants will crossover to the alternate arm (either SHE or dCBT-I) and undergo a final assessment at week 36.Outcomes: The primary outcome will be the mean continuous change in SCI score in the intervention arm compared to the control arm at 24 weeks. Additionally, the proportion of women with an SCI > 16 at 24 weeks will be assessed. Secondary outcomes include fatigue, sleep related quality of life, depression, anxiety, and hot flush interference.