Assessing the Feasibility of a Multi-modal Intervention for Sleep Disturbances in Patients With Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Retention rate
研究概览
简要总结
Research has shown that the incidence of sleep disturbances in people with cancer is much higher than in the general population. Sleep problems can lead to worse symptoms, quality of life, and potentially impact outcomes. The most common treatment of sleep disturbances is medication which often comes with unwanted side-effects and risk. This study aims to test whether a non-drug intervention can be given to people with cancer to help with sleep disturbances.
The study will take place over 8-weeks. The first and final week of the study involves assessments (further described below) while the intervention will take place over weeks 2-7. The intervention involves an online cognitive behavioural therapy course, daily bright light therapy and engaging with an activity plan.
The initial review aims to identify any reversible causes of the sleep disturbance, including reviewing uncontrolled symptoms and medications.
Cognitive behavioural therapy for insomnia (CBT-I) has been shown to be effective at improving the time it takes for people to fall asleep and reducing the amount of time you wake up in the night.
Light therapy mimics our natural exposure to sunlight. Light exposure may help to improve sleep during the night, mood, and activity or attention levels during the day.
Physical activity levels will also be reviewed. Interests and barriers to activity will be discussed and goals will be set for activity. This will be reviewed weekly.
Questionnaires will be completed in the first and final week of the study to assess sleep, symptoms and quality of life. Wrist actigraphy, thigh accelerometry and a sleep diary will also be used on the first and final week of the study to assess sleep, activity and subjective sleep patterns.
详细描述
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
- 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.
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old and over
- •Diagnosis of advanced cancer (locally advanced, metastatic)
- •Subjective sleep disturbance
- •Total score of 5 or more on PSQI
- •Eastern Cooperative Oncology Group (ECOG) performance status 1-3
- •Attending outpatients (oncology and/or palliative care)
- •Estimated prognosis of > 3 months
排除标准
- •ECOG performance status 4
- •Cognitive impairment limiting the ability to complete assessment tools and sleep diary
- •Engaged in shift work
- •A recent exacerbation of symptoms (e.g. pain/nausea/dyspnoea) which may impact sleep
- •History of uncontrolled mania or bipolar disorder
- •Recent history or current thoughts of self-harm or suicide
- •Recent change in antidepressant medication
研究组 & 干预措施
Receiving intervention
Participants recruited to the study will receive the multimodal intervention as described.
干预措施: Online cognitive behavioural therapy for insomnia, bright light therapy, activity (Behavioral)
结局指标
主要结局
Retention rate
时间窗: through study completion - 8 weeks
considering the number of patients who entered the study and completed the study.
Completion of the intervention
时间窗: 8 weeks
Considering engagement with various interventions. The case report form will capture engagement with online cognitive behavioural therapy for insomnia where progress can be viewed online and the sleep diary will be reviewed. The participant will report on use of the bright light therapy box and activity levels throughout the study.
Recruitment
时间窗: one year
considering the number of patients approached to take part in the study who then entered the study
Acceptability
时间窗: 8 weeks
A patient acceptability questionnaire of various aspects of the study, including interventions and study protocol, will be completed at the end of the study.
次要结局
- Sleep quality(Week 8)
- Physical symptoms(Week 8)
研究者
Prof Andrew Davies
Professor of Palliative Medicine
Our Lady's Hospice and Care Services
