The Sleep, Cancer and Rest (SleepCare) Trial: A Randomised, Controlled Trial of Four Treatments for Sleep during Chemotherapy

Interventions will be therapist-assisted with self-directed/automated components. A trained member of the research team will interact with participants in person (if appropriate) or via phone, at the initiation of the intervention (t1) to personalise aspects of delivery, and via phone (or in person if participants are at clinic for another appointment and prefer to meet in person) at mid-point through the intervention (t2). All intervention conditions were devised with the primary goal of minimising participant burden and optimising intervention efficacy. As participants will already be going through an intensive cancer treatment regimen (chemotherapy), the design of the intervention was carefully considered such that the effort and time associated with each intervention component are outweighed by the anticipated benefits. For example, the initial consultation if conducted in-person, will be scheduled around participants’ existing medical appointments to reduce burden of time and travel. All other aspects of the intervention can be completed in the comfort of participants’ own homes, at their leisure. Similarly, the light glasses are comfortable, easy to wear, and are not likely to disrupt participant’s usual morning routines. Wearing the light glasses for 20 minutes per day with glasses fixed at 1500 lux will not impair participants’ ability to move around and undertake any domestic or work-related responsibilities such as preparing and consuming food, household cleaning, reading, writing or typing. Furthermore, the intervention has been designed to be economical from the perspective of the healthcare system, it is simple for clinicians to deliver and entails relatively low financial expense and burden of time. Taken together, the proposed interventions, if shown to be effective, have the potential to be sustainably integrated within routine oncology care. Arm 1 - Cognitive Behavioural Therapy (CBT) Intervention Eligible participants randomised to the CBT and CBT+BLT conditions will receive an abbreviated online-based, resource-orientated variant of cognitive behavioural therapy for insomnia and sleep. The intervention will consist of an initial CBT consult (conducted in-person or via phone; about 60-75-minutes), one phone call (about 30-minutes) and a series of 12 biweekly self-administered emails (about 15-30-minutes). All email content is standardised. The initial CBT consult will be structured but personalised to emphasise aspects most relevant based on individuals' needs and goals. Following the initial CBT consult, participants will then subsequently engage in activities or materials by distance in a self-guided manner (i.e., by reading emails and applying recommended strategies). The primary themes targeted within the proposed adaptation of CBT include behavioural (i.e. timing, conditioning) and psychological (i.e. anxiety, rumination, stress, depression) causes of sleep disturbance and strategies for sleeping with symptoms common to cancer and its associated treatments (i.e. pain, nausea, hot flushes). Broadly, the CBT intervention groups will receive sleep strategies with the following core components: -- general information and skills for better sleep (e.g., sleep hygiene, relaxation and mindfulness exercises, dealing with night-time worries); -- fostering healthy attitudes and expectations about sleep following cancer diagnosis and during oncology treatment; -- managing sleep challenges specific to cancer patients (e.g., physical discomfort, pain, daytime consequences of poor sleep); -- identifying and managing symptoms of insomnia (e.g., self-monitoring, stimulus control, sleep scheduling, bed restriction). The adapted intervention materials were modelled on the core components described in ‘Cognitive Behavioural Treatment of Insomnia Session by Session Guide’ (Perlis, Jungquist, Smith & Posner, 2005). These core components have been demonstrated to improve sleep and are well-suited for use within an abridged intervention time frame (Johnson et al., 2016). Each email will address a unique theme. The total duration of this intervention is 6 weeks. Arm 2 - Bright Light Therapy (BLT) Intervention Participants allocated to the CBT+BLT and BLT conditions will be provided a pair of Luminette(registered) light therapy glasses. The BLT intervention will consist of an initial consultation (conducted in-person or via phone; about 30-45 minutes), one phone call (about 30-minutes) and daily use of the Luminette(registered) light glasses for 20 minutes at their habitual wake time for the six-week duration of the intervention. The initial consultation will follow a structured program but be personalised by the interventionist to individuals' needs and goals, for example taking into typical wake times and daily routines in the scheduling of light glass use. Additionally, participants will receive a brief email each week that will include reminders to promote intervention adherence as well as basic strategies to promote positive sleep habits. Participants will be provided specific instructions during the initial consultation to address both Light Therapy (e.g., seeking bright light upon waking and during the day) and Dark Therapy (e.g., avoiding electronic devices an hour before bedtime, using Nightshift mode), which will be personalised according to their individual routine. Specifically, the initial consultation session will have three objectives: (1) assess participant’s current sleep-wake patterns to inform individualised timing of light glasses; (2) discuss light therapy applications and functions to promote more effective integration in daily use; and, (3) collaboratively identify and problem-solve any foreseeable difficulties concerning adherence to light therapy protocol. Additionally, pertinent information will be provided to participants in the form of a brief Light Therapy Participant Guide, including how/when to use the light glasses, as well as a summary of key Light/Dark Therapy strategies and safety information. Participants will also receive a Luminette(registered) guide for further detailed information regarding their light glasses. Additionally, participants in the BLT alone condition will receive basic sleep hygiene and education information (beyond light/dark therapy) to match what is delivered in SHE (described below). This email content will be standardised so it is the same for all participants. The total duration of this intervention is 6 weeks. Arm 3 - Combined (CBT+BLT) Intervention Participants in this condition will receive both CBT and BLT interventions simultaneously as detailed above. Arm 4 - Sleep Hygiene and Education (SHE) Intervention The Sleep Hygiene and Education intervention group will receive similar time and attention relative to CBT and BLT interventions. Participants will receive one initial consultation covering sleep education and basic sleep hygiene (conducted in-person or via phone; about 30 minutes), a midpoint phone call (about 15 minutes) and weekly emails (about 10 minutes). The initial consultation will follow a structured program, but will be personalised by the interventionist depending on individuals' needs and goals. For example, although all aspects of good sleep hygiene are encouraged, a plan and suggestions will incorporate indivdiuals' daily routines and changes that they are willing and able to commit to. For example, one person may be willing to use caffeine only in the morning but not remove a television from the bedroom. Email modules will review positive sleep hygiene practices and general sleep education materials: -- Purpose and benefits of sleep -- Stages of sleep -- Processes that influence sleep (homeostatic and circadian) -- Sleep disorders (dyssomnias, parasomnias and circadian disruption) -- Tips to modulate light exposure in the evening to improve sleep -- Tips to better regulate temperature overnight to improve sleep -- Guidelines regarding physical activity and its timing to optimise sleep -- Noise reduction techniques to improve sleep -- Tips on the timing and content of food consumption to improve sleep -- Tips on the timing and quantity of caffeine consumption to improve sleep -- Tips on the timing and quantity of alcohol consumption to improve sleep -- Tips for selecting mattress and bedding to improve sleep This email content will be standardised so it is the same for all participants. The total duration of this intervention is 6 weeks.