Impact of Cognitive Behavioural Therapy for Insomnia on Endocrine Therapy Adherence

Breast Cancer Clinical Trial

Official title:

Impact of Cognitive Behavioural Therapy for Insomnia on Endocrine Therapy Adherence: a Mixed Methods Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05887297
• Other study ID #: UEC23/09
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 23, 2023
• Est. completion date: May 23, 2024

Study information

• Verified date: April 2024
• Source: University of Strathclyde
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: May 23, 2024
• Est. primary completion date: May 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Medication
• Breast Cancer
• Insomnia
• Quality of Life
• Sleep Initiation and Maintenance Disorders
• Survivorship

Intervention

Behavioral:
• Cognitive behavioural therapy for insomnia
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.

Locations

Country	Name	City	State
United Kingdom	University of Strathclyde	Glasgow	County (optional)

Sponsors (1)

Lead Sponsor	Collaborator
University of Strathclyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	Total sleep time	Time spent asleep, measured using Consensus sleep diary.	12 weeks
Secondary	Sleep onset latency	Time taken from getting into bed to falling asleep, measured using Consensus sleep diary.	12 weeks
Secondary	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.	12 weeks