Clinical trial · Interventional
Impact of Cognitive Behavioural Therapy for Insomnia on Endocrine Therapy Adherence
Impact of Cognitive Behavioural Therapy for Insomnia on Endocrine Therapy Adherence: a Mixed Methods Pilot Study
NCT05887297CI-TRIAL-00098906completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adherence, Medication | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Insomnia | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Survivorship | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive behavioural therapy for insomnia | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cognitive behavioural therapy for insomnia
- description
- Following randomisation, participants in the intervention group will receive the CBT-I intervention, delivered over 4 weeks.
- interventionNames
- Behavioral: Cognitive behavioural therapy for insomnia
- type
- NO_INTERVENTION
- label
- Waitlist control
- 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.
Primary outcomes (1)
- measure
- Endocrine therapy adherence
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDCai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2. PMID 41170811