Clinical trial NCT05887297: Impact of Cognitive Behavioural Therapy for Insomnia on Endocrine Therapy Adherence
Official title: Impact of Cognitive Behavioural Therapy for Insomnia on Endocrine Therapy Adherence: a Mixed Methods Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Insomnia
Breast Cancer
Adherence, Medication
Quality of Life
Survivorship
Lead sponsor: University of Strathclyde
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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

Primary outcomes:
measure: Endocrine therapy adherence
timeFrame: 12 weeks
Secondary outcomes:
measure: Insomnia symptoms
timeFrame: 12 weeks
measure: Depressive symptoms
timeFrame: 12 weeks
measure: Anxiety symptoms
timeFrame: 12 weeks
measure: Fatigue
timeFrame: 12 weeks
measure: Musculoskeletal pain
timeFrame: 12 weeks
measure: Vasomotor symptoms
timeFrame: 12 weeks
measure: Sleep efficiency
timeFrame: 12 weeks
measure: Total sleep time
timeFrame: 12 weeks
measure: Sleep onset latency
timeFrame: 12 weeks
measure: Wake after sleep onset
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: University of Strathclyde
state: County (optional)
Study officials:
References: