The aim of this study is to investigate the impact of cognitive behavioural therapy for insomnia on adherence to endocrine therapy medication in breast cancer survivors.
Approximately 70% of breast cancer cases are hormone-receptor positive, therefore treatable with endocrine therapy medication. When taken as prescribed, this is effective in reducing the risk of breast cancer recurrence following primary treatment. However, research indicates that nonadherence (not taking medication as prescribed, whether due to forgetfulness or deliberately missing a dose) is an issue, with side effects being a consistent predictor of nonadherence. Sleep problems are one of the most common endocrine therapy side effects. The aim of this study is to explore the influence of cognitive behavioural therapy for insomnia (CBT-I) on endocrine therapy adherence in breast cancer survivors. Participants will be randomised to 1 of 2 groups: intervention, or waitlist control. Both groups will complete measures of sleep and other endocrine therapy side effects (depression, anxiety, fatigue, musculoskeletal pain, and vasomotor symptoms) at baseline, post-intervention, and 12-week post-randomisation follow-up. Following randomisation, the intervention group will receive 4 weekly group CBT-I sessions remotely through videoconferencing, whereas waitlist control participants will receive the intervention after 12 weeks, once all measures are completed. Primary outcome will be self-reported endocrine therapy adherence, with secondary outcomes including insomnia symptoms and other endocrine therapy side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
35
CBT-I is a multi-component, evidence-based intervention which incorporates both cognitive and behavioural techniques to address symptoms of insomnia, aiming to improve satisfaction with the duration and quality of sleep by reducing trouble falling and/or staying asleep. CBT-I will be delivered over 4 weekly 1-hour sessions, via videoconferencing. Session 1 will include psychoeducation about sleep (the relationship between sleep and mental health, the '3P' model of insomnia), and begin to explain components of CBT-I (sleep restriction and relaxation). Session 2 will reinforce previous learning about these components and introduce stimulus control. Session 3 will introduce sleep hygiene and its importance in preventing poor sleep. Session will 4 discuss cognitive therapy techniques and relapse prevention.
University of Strathclyde
Glasgow, County (Optional), United Kingdom
Endocrine therapy adherence
Primary outcome will be self-reported adherence to endocrine therapy medication, measured using the Medication Adherence Report Scale (MARS-5). Items are scored from 1-5. Responses are summed to create a total ranging from 1-20, with higher scores indicating better adherence.
Time frame: 12 weeks
Insomnia symptoms
Severity of insomnia symptoms, measured using the Sleep Condition Indicator. Items are scored from 0-4. Responses are summed to create a total score ranging from 0-32, with higher scores meaning better sleep.
Time frame: 12 weeks
Depressive symptoms
Measured using the Patient Health Questionnaire (PHQ-9). Items are scored from 0-3. Responses are summed to create a total score ranging from 0-27, with higher scores meaning more severe depressive symptoms.
Time frame: 12 weeks
Anxiety symptoms
Measured using the Generalised Anxiety Disorder Assessment (GAD-7). Items are scored from 0-3. Responses are summed to create a total score ranging from 0-21, with higher scores meaning more severe anxiety.
Time frame: 12 weeks
Fatigue
Measured using the Flinders Fatigue Scale (FFS). This measure includes 7 items. Six items are scored from 0-4, whereas item 5 includes a checklist which is scored from 0-7. Responses are summed to create a total score of 0-31.
Time frame: 12 weeks
Musculoskeletal pain
Measured using musculoskeletal subscale of Breast Cancer Eight Symptom Scale. This subscale includes 3 items, scored from 1-3. Scores are summed, multiplied by the number of items in the subscale, and then divided by the number of questions answered, with higher scores indicating worse symptoms.
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Time frame: 12 weeks
Vasomotor symptoms
Measured using vasomotor subscale of Breast Cancer Eight Symptom Scale. This subscale includes 3 items, scored from 1-3. Scores are summed, multiplied by the number of items in the subscale, and then divided by the number of questions answered, with higher scores indicating worse symptoms.
Time frame: 12 weeks
Sleep efficiency
The proportion of time spent in bed which is spent sleeping, measured using Consensus sleep diary. This calculated by dividing the time spent sleeping by time spent in bed, then multiplying this by 100 to generate time spent sleeping as a % of time in bed.
Time frame: 12 weeks
Total sleep time
Time spent asleep, measured using Consensus sleep diary.
Time frame: 12 weeks
Sleep onset latency
Time taken from getting into bed to falling asleep, measured using Consensus sleep diary.
Time frame: 12 weeks
Wake after sleep onset
Amount of time spent awake after initially falling asleep, measured using Consensus sleep diary. This is calculated by adding up the length of all night-time awakenings to create a total in minutes.
Time frame: 12 weeks