Impact of Cognitive Behavioural Therapy for Insomnia on Endocrine Therapy Adherence: a Mixed Methods Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Strathclyde
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Endocrine therapy adherence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Endocrine therapy adherence
Time Frame: 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 Outcomes
- Fatigue(12 weeks)
- Insomnia symptoms(12 weeks)
- Vasomotor symptoms(12 weeks)
- Sleep onset latency(12 weeks)
- Depressive symptoms(12 weeks)
- Total sleep time(12 weeks)
- Wake after sleep onset(12 weeks)
- Anxiety symptoms(12 weeks)
- Musculoskeletal pain(12 weeks)
- Sleep efficiency(12 weeks)
Investigators
Sommer Agnew
Principal Investigator
University of Strathclyde