Sleep Well At Night

NCT07068971 | Enrolling By Invitation

• 1 other identifier: RS23-076
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Sleep Disturbance in Advanced Cancer

Keywords

Non-pharmacological; Multimodal; Interventional; Feasibility study; Advanced cancer

Outcome Measures

Primary Outcomes (4)

• Retention rate

  considering the number of patients who entered the study and completed the study.

  through study completion - 8 weeks

• Recruitment

  considering the number of patients approached to take part in the study who then entered the study

  one year

• Completion of the intervention

  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.

  8 weeks

• Acceptability

  A patient acceptability questionnaire of various aspects of the study, including interventions and study protocol, will be completed at the end of the study.

  8 weeks

Secondary Outcomes (2)

• Sleep quality

  Week 8

• Physical symptoms

  Week 8

Study Arms (1)

Receiving intervention

EXPERIMENTAL

Participants recruited to the study will receive the multimodal intervention as described.

Behavioral: Online cognitive behavioural therapy for insomnia, bright light therapy, activity

Interventions

Online cognitive behavioural therapy for insomnia, bright light therapy, activity BEHAVIORAL

Multimodal intervention

Receiving intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inpatient
• 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

Sponsors & Collaborators

• Our Lady's Hospice and Care Services: lead
• St Vincent's University Hospital, Ireland: collaborator

Study Sites (1)

Our Lady's Hospice & Care Services

Dublin, Ireland

Location

MeSH Terms

Interventions

Ultraviolet Therapy; Exercise

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Professor Andrew Davies

  Our Lady's Hospice & Care Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Palliative Medicine

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 16, 2025
• Study Start: August 19, 2024
• Primary Completion: August 24, 2025
• Study Completion: August 24, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)