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

Abstract

Background Women with breast cancer experience a significantly higher prevalence of sleep disturbances and insomnia compared with the general population. The experience of persistent sleep disturbance places breast cancer patients at a higher risk of psychological and physical morbidity and a reduced quality of life. Treatment of sleep in this population is not standard and is often inadequately managed. This randomised controlled study will examine the effects of both Cognitive Behavioural Therapy for insomnia and sleep (CBT-I) and bright light therapy (BL) on the symptoms of insomnia, fatigue and mental health. Method/design Women diagnosed with breast cancer who are or will be receiving intravenous chemotherapy treatment at a major metropolitan cancer centre in Melbourne will be recruited (n=80). Recruitment will occur after diagnosis and prior to completion of chemotherapy. Eligible participants will be randomised to the CBT+ intervention (CBT and BL) or relaxation audio enhanced treatment as usual (TAU+). The intervention group will receive one face-to-face session on sleep strategies, one telephone call, and seven email packages containing CBT-I based information and strategies. Participants will also wear Luminette light glasses for 20 minutes each morning for the six-week duration of the intervention. 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) measure. Data will also be collected on potential treatment moderators and mechanisms, and adherence to treatment. There will be 3-month follow-up measurements of fatigue, sleep-related impairment, sleep disturbance, depression, and anxiety. Discussion This is the first randomised controlled trial to combine CBT and BL for the treatment of sleep disturbances 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 dissemination.