ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001255279

Ethics application status

Approved

Date submitted

23/07/2018

Date registered

25/07/2018

Date last updated

4/04/2022

Date data sharing statement initially provided

16/09/2019

Date results provided

4/04/2022

Type of registration

Retrospectively registered

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1217-9000

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

breast cancer

sleep disruption

Condition category

Condition code

Cancer

Breast

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Behaviour

Comparator / control treatment

Control Intervention
The control group will receive two emails containing web links to relaxation audio tracks. These emails will be received during the first and third week of the intervention. The first relaxation audio consists of abdominal breathing strategies that may assist in calming the mind and relaxing the body. The second audio consist of a body scan relaxation, both audio tracks are approximately 15 minutes and participants are instructed to listen to these audio tracks each day, whenever they feel they might be beneficial. These relaxation tracks were developed by the cancer council to assist patients in coping with a cancer diagnosis. The relaxation audio tracks do not contain any sleep specific information, instead, they include general relaxation strategies that can be used by participants at any time during the day or night. The control group will also receive a brief phone call (15 minutes) during the fourth week of their study involvement to check in with participants’ and respond to any queries or complaints. The phone call will be delivered by a provisional psychologist who has received specialist training in sleep.
Following the final follow-up assessment, the control group will receive the set of CBT+ email packages, an additional information booklet detailing the contents of the face-to-face session and an information booklet on light therapy.
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.

Control group

Active

Outcomes

Primary outcome [1]

Symptoms of insomnia assessed via the Insomnia Severity Index (ISI; Bastien, Vallières, & Morin, 2001).

Timepoint [1]

Baseline (Week 0), Midpoint (Week 3), Post-Treatment (Week 6), and Follow-Up (3 months), used to estimate slopes over time. There is no single primary timepoint as we are using the change over time in outcome to define the success/failure of the trial.

Primary outcome [2]

Sleep Diary - Sleep Efficiency

Timepoint [2]

Continuously assessed over the 6 weeks of the trial and used to estimate slopes over time. There is no single primary timepoint as we are using the change over time in outcome to define the success/failure of the trial.

Secondary outcome [1]

Sleep Diary – Sleep Onset Latency

Timepoint [1]