Impact of Cognitive Behavioural Therapy for Insomnia on Endocrine Therapy Adherence

Trial Title: Impact of Cognitive Behavioural Therapy for Insomnia on Endocrine Therapy Adherence

NCT ID: NCT05887297

Condition: Insomnia
Breast Cancer
Adherence, Medication
Quality of Life
Survivorship

Conditions: Official terms:
Sleep Initiation and Maintenance Disorders

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Participants will be randomly allocated to either intervention group or waitlist control. Intervention group will receive CBT-I intervention following randomisation. Waitlist control group will receive CBT-I after all measures have been completed.

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Cognitive behavioural therapy for insomnia
Description: 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.
Arm group label: Cognitive behavioural therapy for insomnia

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Strathclyde

Address:
City: Glasgow
Zip: G1 1XQ
Country: United Kingdom

Start date: March 23, 2023

Completion date: May 23, 2024

Lead sponsor:
Agency: University of Strathclyde
Agency class: Other

Source: University of Strathclyde

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05887297