Impact of Cognitive Behavioural Therapy for Insomnia on Endocrine Therapy Adherence

University of Strathclyde

Status: Completed

Conditions: Breast Cancer; Quality of Life; Adherence, Medication; Survivorship; Insomnia

Treatments: Behavioral: Cognitive behavioural therapy for insomnia

Study type: Interventional

Funder types: Other

Identifiers

NCT05887297

UEC23/09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Cognitive behavioural therapy for insomnia

Experimental group

Description:

Following randomisation, participants in the intervention group will receive the CBT-I intervention, delivered over 4 weeks.

Treatment:

Behavioral: Cognitive behavioural therapy for insomnia

Waitlist control

No Intervention group

Description:

Participants in the waitlist condition will complete all measures at the same timepoints as the intervention group. They will receive the CBT-I intervention after completing the 12-week follow-up assessment. This will then be used as a baseline measure for these participants to compare to their post-intervention and follow-up after receiving the treatment.