Impact of Cognitive Behavioural Therapy for Insomnia on Endocrine Therapy Adherence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-23

Study Completion Date

2024-04-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Insomnia Breast Cancer Adherence, Medication Quality of Life Survivorship

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Cognitive behavioural therapy for insomnia

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

Group Type EXPERIMENTAL

Cognitive behavioural therapy for insomnia

Intervention Type BEHAVIORAL

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.

Waitlist control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No