Abstract
BackgroundWomen with breast cancer experience a significantly higher prevalence of sleep disturbance and insomnia than the general population. The experience of persistent sleep disturbance places these women at a higher risk of psychological and physical morbidity and a reduced quality of life. Treatment for sleep in this population is not part of routine care and is often managed inadequately. This randomised controlled trial will examine the combined effects of cognitive behavioural therapy (CBT) and bright light therapy (BLT) on the symptoms of insomnia, fatigue and mental health.Method/designWomen diagnosed with breast cancer who receive intravenous chemotherapy treatment at a quaternary referral metropolitan cancer centre in Melbourne, Australia, will be recruited. Recruitment will occur after diagnosis and prior to completion of chemotherapy. Eligible women will be randomised to the combined CBT and BLT intervention (CBT+) or relaxation audio-enhanced treatment as usual (TAU+). The CBT+ group will receive one face-to-face session on sleep strategies, one subsequent telephone call, and seven email packages containing CBT-based information and strategies. CBT+ participants will also wear Luminette® light glasses for 20 min each morning for the 6-week duration of the intervention. Women in TAU+ will receive two relaxation audio tracks via email. Outcomes will be measured at multiple points throughout the 6 weeks. Primary outcomes will be symptoms of insomnia and sleep efficiency, measured using the Insomnia Severity Index and a self-reported sleep diary. Secondary outcomes include objective measures of sleep assessed using the ActiGraph wGT3X-BT, and sleep-related complaints, fatigue and mental health, all assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS). Data will also be collected on potential treatment moderators and mechanisms and adherence to treatment. There will be 3-month follow-up measurements of insomnia symptoms, fatigue, sleep-related impairment, sleep disturbance, depression and anxiety.DiscussionThis is the first randomised controlled trial to combine CBT and BLT for the treatment of sleep disturbance in women with breast cancer. This novel design addresses the multiple causal factors for sleep complaints in this population. Results from this trial will advance knowledge in this field and may have important clinical implications for how best to treat sleep disturbance and insomnia in this population. If effective, the largely email-based format of the intervention would allow for relatively easy translation.Trial RegistrationAustralian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12618001255279. Retrospectively registered on 25 July 2018.
Highlights
Women with breast cancer experience a significantly higher prevalence of sleep disturbance and insomnia than the general population
In this randomised controlled trial, we evaluate the efficacy of cognitive behavioural therapy (CBT)+ versus treatment as usual enhanced with relaxation audio (TAU+) in women being treated with chemotherapy for Breast cancer (BC)
X indicates measure administered at that time point; N items indicates the number of items in each scale; a continuous line indicates measured/undertaken continuously CBT+ combined cognitive behavioural therapy and bright light therapy, PROMIS Patient-Reported Outcomes Measurement Information System, TAU+ treatment as usual plus relaxation audios participants’ average self-reported sleep efficiency (SEs) between the first week and the last week of the intervention
Summary
One large randomised controlled trial that systematically approached women for a sleep intervention during treatment for BC had a 22% rate of consent to the randomised controlled trial following screening [32] Another randomised controlled trial of people who had finished primary cancer treatment contacted 2531 people, of whom 327 (12.9%) expressed interest and 250 were eligible. 47.2% of women who were eligible and approached consented This relatively high consent rate, considering that women were undergoing chemotherapy and none had expressed prior interest nor been referred by their physicians, provides evidence supporting the intervention design and the feasibility for treating sleep disturbance during rather than after chemotherapy treatment.
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