Clinical trial · Interventional
Sleep Well At Night
Assessing the Feasibility of a Multi-modal Intervention for Sleep Disturbances in Patients With Advanced Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sleep Disturbance in Advanced Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Online cognitive behavioural therapy for insomnia, bright light therapy, activity | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Receiving intervention
- description
- Participants recruited to the study will receive the multimodal intervention as described.
- interventionNames
- Behavioral: Online cognitive behavioural therapy for insomnia, bright light therapy, activity
Primary outcomes (4)
- measure
- Retention rate
- timeFrame
- through study completion - 8 weeks
- description
- considering the number of patients who entered the study and completed the study.
- measure
- Recruitment
- timeFrame
- one year
- description
- considering the number of patients approached to take part in the study who then entered the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 years old and over 2. Diagnosis of advanced cancer (locally advanced, metastatic) 3. Subjective sleep disturbance 4. Total score of 5 or more on PSQI 5. Eastern Cooperative Oncology Group (ECOG) performance status 1-3 6. Attending outpatients (oncology and/or palliative care) 7. Estimated prognosis of \> 3 months Exclusion Criteria: 1. Inpatient 2. ECOG performance status 4 3. Cognitive impairment limiting the ability to complete assessment tools and sleep diary 4. Engaged in shift work 5. A recent exacerbation of symptoms (e.g. pain/nausea/dyspnoea) which may impact sleep 6. History of uncontrolled mania or bipolar disorder 7. Recent history or current thoughts of self-harm or suicide 8. Recent change in antidepressant medication
References
Publications (0)
Data not yet available