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Completed

NCT Number: NCT05887297

Impact of Cognitive Behavioural Therapy for Insomnia on Endocrine Therapy Adherence

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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Key information

Conditions

Insomnia Adherence, Medication Behavior Breast Cancer Breast Diseases Breast Neoplasms Dyssomnias Health Behavior Medication Adherence Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Patient Acceptance of Health Care Patient Compliance Quality of Life Skin Diseases Skin and Connective Tissue Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Survivorship Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Strathclyde

Glasgow, County (Optional), G1 1XQ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioural Therapy for Insomnia

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.

Primary outcomes

  1. Endocrine therapy adherence

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. Insomnia symptoms

    Time frame: 12 weeks

    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.

  2. Depressive symptoms

    Time frame: 12 weeks

    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.

  3. Anxiety symptoms

    Time frame: 12 weeks

    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.

  4. Fatigue

    Time frame: 12 weeks

    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.

  5. Musculoskeletal pain

    Time frame: 12 weeks

    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.

  6. Vasomotor symptoms

    Time frame: 12 weeks

    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.

  7. Sleep efficiency

    Time frame: 12 weeks

    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.

  8. Total sleep time

    Time frame: 12 weeks

    Time spent asleep, measured using Consensus sleep diary.

  9. Sleep onset latency

    Time frame: 12 weeks

    Time taken from getting into bed to falling asleep, measured using Consensus sleep diary.

  10. Wake after sleep onset

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Strathclyde

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 2, 2023
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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