Impact of Cognitive Behavioural Therapy for Insomnia on Endocrine Therapy Adherence
- Conditions
- Breast CancerAdherence, MedicationSurvivorshipQuality of LifeInsomnia
- Interventions
- Behavioral: Cognitive behavioural therapy for insomnia
- Registration Number
- NCT05887297
- Lead Sponsor
- University of Strathclyde
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 35
- Diagnosed with breast cancer
- Aged 18 or over
- Currently prescribed endocrine therapy medication
- Experience symptoms of insomnia
- Self-reported nonadherent to ET medication (e.g. forgetting to take, or deliberately taking a break from medication)
- Proficient in English language
- Access to videoconferencing
- Undertaking shift work (i.e., irregular or night shifts)
- Pregnancy or breastfeeding
- Other unstable physical or mental health problem (including substance misuse)
- Received CBT-I within past 12 months
- Received chemotherapy or radiotherapy within past 4 weeks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive behavioural therapy for insomnia Cognitive behavioural therapy for insomnia Following randomisation, participants in the intervention group will receive the CBT-I intervention, delivered over 4 weeks.
- Primary Outcome Measures
Name Time Method Endocrine therapy adherence 12 weeks 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.
- Secondary Outcome Measures
Name Time Method Fatigue 12 weeks 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.
Insomnia symptoms 12 weeks 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.
Vasomotor symptoms 12 weeks 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.
Sleep onset latency 12 weeks Time taken from getting into bed to falling asleep, measured using Consensus sleep diary.
Depressive symptoms 12 weeks 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.
Total sleep time 12 weeks Time spent asleep, measured using Consensus sleep diary.
Wake after sleep onset 12 weeks 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.
Anxiety symptoms 12 weeks 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.
Musculoskeletal pain 12 weeks 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.
Sleep efficiency 12 weeks 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.
Trial Locations
- Locations (1)
University of Strathclyde
🇬🇧Glasgow, County (optional), United Kingdom