Sleep Well At Night

Advances in cancer treatments have improved prognosis for many patients, placing a heightened demand on clinical care to provide quality of life as well as quantity of life. Individuals with advanced cancer face progressive symptoms that are a major source of suffering and impairment. Sleep disturbance is a prevalent, but often overlooked symptom, affecting up to 96% of patients with advanced cancer. While there are multiple types of sleep disorders affecting patients with advanced cancer, insomnia seems to be the most prevalent sleep disorder in this patient cohort, occurring at various points in the patient's disease and treatment trajectory. Adequate sleep is essential for maintaining normal function and overall existence. Inadequate sleep may further compound illness and impair recovery. Sleep disturbances are associated with fatigue, accidents/injuries, anxiety and depression, cognitive impairment and delirium and immunosuppression. In addition, sleep disturbance is associated with aberrant patterns of cortisol secretion, which can impair the cellular immunity responsible for mounting a defence against tumours. Pharmacotherapy is the most common treatment for sleep disturbances, despite the numerous associated adverse effects and absence of empirical evidence of their efficacy and innocuity in this patient population. Multiple studies have recognised that patients with advanced cancer are at an increased risk of harm induced by medications due to age, polypharmacy and co-morbidities that can alter pharmacodynamics. Yet, despite the evidence of harmful effects of hypnotics and the lack of evidence to support their use, they are routinely prescribed as first-line treatment for the management of sleep disturbances in patients with advanced cancer.

Cognitive behavioural therapy for insomnia (CBT-I) is considered the non-pharmacological first-line treatment to manage insomnia in adults. CBT for insomnia includes various components that helps the patient to learn coping skills and ways to prevent or mitigate the severity of future episodes.

Both bright white light therapy and exercise have proven to be successful non-pharmacological methods of optimising daytime activity, improving sleep duration and enhancing symptoms and quality of life in patients with cancer.

Study interventions

1. CBT-I is a first-line treatment for insomnia. The online course consists of four CBT-I sessions and allows the individual to complete one module per week in the comfort of their own home. Online CBT-I has been shown to be as effective as face-to-face CBTI. CBT-I covers cognitive and behavioural aspects to understand sleep processes and improve sleep duration and quality.
2. Bright light therapy has been shown to be effective at improving night-time sleep and daytime physical activity. It is delivered from a light box. The participants will be advised to sit near the light box for 30 minutes each morning. Participants can continue with other activities, such as eating breakfast, whilst sitting with the light box.
3. An individualised physical activity plan will be created to encourage increased daytime physical activity and reduced daytime sedentary behaviour. Existing physical activity levels will be considered, any barriers to physical activity addressed, and goals for physical activity set. These will be reviewed on a weekly basis and adjusted as appropriate. For example, if goals are easily being achieved, further activity increases will be advised. If the patient struggles to meet goals, their goal will be lowered. Patients will be provided with a generic watch activity tracker to help them to monitor their progress.

Study Duration/ Study Timeline:

All participants will receive the intervention over an 8-week period. Where possible, participants baseline and repeat assessments will be arranged to avoid assessments taking place during a week of intravenous systemic anticancer therapy as this may impact symptoms and results.

At baseline, participants will complete three questionnaires related to symptoms, sleep disturbance and quality of life. Participants will be given a Polar Unite watch to wear for the duration of the study (8 weeks) as a primary objective measure for the purpose of measuring sleep and activity. Participants will also complete a sleep diary during the first week and wear a thigh accelerometer as a secondary objective outcome to measure activity including time spent lying, sitting, standing and stepping.

At the end of week one, participants will return the sleep diary and thigh accelerometer and they will be provided with and educated on the use of the bright white light box and the CBT-I platform. An individualised activity plan will be created between the research team and the participant. Participants will receive 6 weeks of the intervention prior to a final week where they repeat the questionnaires, thigh accelerometer and diary completion. Weekly virtual contacts will take place throughout the intervention. These will consider adverse events, technical complications, to advise on adjustments to the activity plan and to encourage engagement with the intervention.

Baseline - beginning of week one Participants will attend to meet the researcher at a convenient location. The initial clinical review is expected to take approximately 60 minutes. A checklist will be used throughout to ensure all steps are completed. The participant will be provided with a Polar Unite watch, a thigh accelerometery device and a sleep diary. The participant will wear the Polar Unite watch for the duration of the study (8 weeks). They will wear the thigh accelerometer device for 3 days and 3 nights (+/- 3 days and 3 nights to allow for flexibility in the case of clashing appointments/bank holidays) of the first week to capture their baseline activity and for 3 days and 3 nights (+/- 3 days and 3 nights to allow for flexibility in the case of clashing appointments/bank holidays) of the final week (post-intervention). The thigh accelerometer and sleep diary will be returned/collected on Friday (+/- 3 days and 3 nights to allow for flexibility in the case of clashing appointments/bank holidays) of the same week and at this point the patient will begin to receive the intervention (CBT-I, bright white light therapy and their activity plan).

The baseline assessment may highlight physical/psychological symptoms abnormalities. In this event, and with the patient's verbal consent, the clinical team (GP, oncologist, palliative physician) will be made aware of the findings to review further.

The consent form and baseline assessments will be completed to include:

1. Demographics: Age, sex, race, living situation, bedroom situation, sleep posture.
2. Clinical history: cancer history (date of diagnosis, type of cancer, stage of cancer and current oncology treatment, past medical history, medication).
3. Lifestyle: smoking history, caffeinated drink use, alcohol use, daily activity.
4. The following assessment tools; PSQI MSAS-SF EORTC QLQ-C15-PAL Dreams \& Nightmares Questionnaire

End of week one The researcher will meet with the participant again on Friday of week one (+/- 3 days and 3 nights to allow for flexibility in the case of clashing appointments/bank holidays). This meeting will focus on an introduction to the interventions and the rationale behind them, including CBT-I and bright white light therapy. It will also involve a discussion around personal interests, barriers to activity, and goals to improve activity levels throughout the day.

Weeks 2-7 - Ongoing intervention Virtual contacts will occur over the phone. The research team will assess for any technical challenges. Goals will be recalled and engagement in the intervention encouraged and any barriers will be addressed.

Week 8 - Completion of intervention and repeat monitoring The researcher will meet with the participant on Monday (+/- 3 days and 3 nights to allow for flexibility in the case of clashing appointments/bank holidays) and repeat the assessment tools (PSQI, MSAS-SF, EORTC QLQ-C15-PAL). The thigh accelerometer and sleep diary will be repeated again for 3 days and 3 nights and returned/collected on the Friday (+/- 3 days and 3 nights to allow for flexibility in the case of clashing appointments/bank holidays).