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Sleepwell: A Trial to Improve Sleep During Chemotherapy for Breast Cancer

Light Enhanced Cognitive Behavioural Therapy (CBT+) for Sleep and Fatigue: A Randomized Controlled Trial during Chemotherapy for Breast Cancer

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001255279
Enrollment
101
Registered
2018-07-25
Start date
2018-07-24
Completion date
2019-10-30
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to test the effectiveness of cognitive behaviour therapy in combination with light therapy compared to relaxation audio. Who is it for? You may be eligible for this study if you are a woman aged over 18, have a diagnosis of primary breast cancer (any stage) and are receiving (or will receive) chemotherapy. Study details Participants will be randomised (by chance) to one of two treatments. One treatment (the Intervention group) is a cognitive behavioural therapy session in addition to use of Light glasses to be worn for 30 minutes each morning. The other group (the Control group) will receive relaxing audio tracks by email. The Control group will receive the information provided to the Intervention group after 3 months. All participants (both groups) will fill out a sleep diary, fill out a questionnaire and wear a watch that measures sleep. It is hoped that this research will help us understand whether a combined behavioural and bright light intervention can reduce sleep disruption and fatigue during chemotherapy for breast cancer and provide a basis for expanding the treatment to people with other types of cancer.

Interventions

CBT+ Intervention The intervention was designed to deliver effective results whilst being as least burdensome as possible. Given that women with breast cancer are already subjected to an intensive treatment regimen, the design of the intervention was carefully considered such that the effort and time associated with each intervention component are outweighed by the likely physical and psychological benefits. The face-to-face session will be scheduled around participants’ existing appointments at

CBT+ Intervention The intervention was designed to deliver effective results whilst being as least burdensome as possible. Given that women with breast cancer are already subjected to an intensive treatment regimen, the design of the intervention was carefully considered such that the effort and time associated with each intervention component are outweighed by the likely physical and psychological benefits. The face-to-face session will be scheduled around participants’ existing appointments at the Peter MacCallum Cancer Centre 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. The light glasses are comfortable, easy to wear, and are not likely to disrupt participant’s usual morning routines. Wearing the light glasses 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 is also economical from the perspective of the healthcare system, it is simple for clinicians to deliver and entails minimal financial expense and burden of time. These are important considerations when evaluating whether the intervention, if effective, could be implemented into routine care. In this study, the intervention will be delivered by a provisional psychologist who has received specialist training in cognitive behavioral therapy for sleep. Cognitive Behavioural Therapy Those participants allocated to the intervention group will receive ‘cognitive behavioural and bright therapy’ (CBT+). CBT+ is delivered via one 75-minute face to face session, one phone call lasting approximately 30 minutes and a series of 7 emails, one per week, that take approximately 15-20 minutes to read. Generally, the intervention group 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 nighttime worries); • fostering healthy attitudes and expectations about sleep following cancer diagnosis and during 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 intervention materials for the CBT+ component were adapted from the Cognitive Behavioural Treatment of Insomnia Session by Session Guide (Perlis, Jungquist, Smith & Posner, 2005). This adapted version of CBT-I is designed to maximise treatment outcomes whilst promoting sustainable integration with current oncological care at the VCCC. Bright Light Therapy Individualised Protocol The light therapy component will consist of daily light glasses use for the six-week duration of the intervention. Participants will receive a pair of Luminette light glasses to take home with them during the face to face CBT-I session and will be instructed to wear them for 30 minutes upon awakening each morning. Specific timing of light glasses use will be established individually with each participant during the face-to-face session. This guide will cover key components when discussing light and dark therapy with participants during the face to face session. The goals are to: • assess current sleep/wake patterns and individualise light/dark exposure; • explain the functions of light therapy so participants understand how to apply strategies in their daily experiences; and • discuss potential barriers to using light glasses and engaging in light therapy more generally, collaboratively brainstorming solutions. Note: Participants with very advanced (habitual bedtime before 8am and risetime before 4am)/delayed sleep timing (habitual bedtime after 3am and risetime after 11am), or have irregular or non-24 sleep/wake patterns are excluded based on the Duke interview. Participants will be asked to wear a wrist-worn watch-like device throughout the entirety of the intervention to objectively measure sleep. Adherence will be assessed by: accessing read and click information from emails including a comprehension check question included in each email and daily reports of the time and duration light glasses were worn.

Sponsors

Peter MacCallum Cancer Centre
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion criteria include: 1. Diagnosed with any stage primary BC 2. Over 18 years of age 3. Receiving or will receive during the study period intravenous chemotherapy, with or without radiotherapy 4. Able to provide informed consent 5. Able to understand and speak English 6. Able to regularly receive and access emails 7. Able and willing to wear bright light glasses 8. Recruitment and consent occurs at the Peter MacCallum Cancer Centre chemotherapy day unit so participants must have an appointment for chemotherapy at the Peter MacCallum Cancer Centre.

Exclusion criteria

Exclusion criteria: 1. Being male 2. Receiving only neoadjuvant chemotherapy 3. Severe psychiatric disorder 4. Severe substance use disorder 5. History of suffering migraines 6. Individuals with very advanced (habitual bedtime before 8pm and rise time before 4am)/delayed sleep timing (habitual bedtime after 3am and rise time after 11am), or have irregular or non-24 sleep/wake patterns are excluded based on the Duke structured sleep interview.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 27, 2026