Journal Article

Light-enhanced cognitive behavioural therapy for sleep and fatigue: study protocol for a randomised controlled trial during chemotherapy for breast cancer

Francis, Prudence A., Wiley, Joshua F., Little, Ruth, Ftanou, Maria, Bei, Bei, Alexander, Marliese, Diggens, Justine, Bean, Helena R., Stafford, Lesley

2020

Overview

Background Women 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/design Women 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. Discussion This 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 Registration Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12618001255279 . Retrospectively registered on 25 July 2018.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Administration, Intravenous / Adult / Aged / Aged, 80 and over / Antineoplastic Agents - administration & dosage / Anxiety / Anxiety - etiology / Anxiety - therapy / Australia / Behavior modification / Behavioral medicine / Biomedicine / Breast cancer / Breast Neoplasms - complications / Breast Neoplasms - drug therapy / Cancer research / Cancer therapies / Care and treatment / Chemotherapy / Circadian rhythm / Clinical trials / Cognitive behavioral therapy / Cognitive Behavioral Therapy - methods / Cognitive behavioural therapy / Comorbidity / Depression - etiology / Depression - therapy / Fatigue / Fatigue - etiology / Fatigue - therapy / Female / Follow-Up Studies / Health aspects / Health Sciences / Humans / Insomnia / Intervention / Light / Light therapy / Medicine / Medicine & Public Health / Mental depression / Mental Health / Metastasis / Middle Aged / Phototherapy / Phototherapy - methods / Physiology / Psychological aspects / Quality of Life / Radiation therapy / Randomised controlled trial / Randomized Controlled Trials as Topic / Self Report / Sleep / Sleep Initiation and Maintenance Disorders - etiology / Sleep Initiation and Maintenance Disorders - therapy / Statistics for Life Sciences / Study Protocol / Systematic review / Young Adult