Clinical trial · Interventional
The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients
NCT05226078CI-TRIAL-00123265active not recruitingN/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)
Cancer-related fatigue (CRF) and insomnia are prevalent among cancer patients and have been linked to de-creases in quality of life and poorer overall survivorship. Currently, the mechanisms underlying CRF are not well understood, which has led to treatments that are only moderately effective. In addition, when compared to CBT-I in the general population, the treatment outcomes in CBT-I with cancer patients are subpar and, as such, this study will evaluate whether dose of CBT-I is effective in ameliorating CRF.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-related Problem/Condition | — | UNRESOLVED | — |
| Cancer-Related Syndrome | — | UNRESOLVED | — |
| Chronic Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Four Sessions of CBT-I
- interventionNames
- Behavioral: Cognitive Behavioral Therapy for Insomnia
- type
- EXPERIMENTAL
- label
- Eight Sessions of CBT-I
- interventionNames
- Behavioral: Cognitive Behavioral Therapy for Insomnia
- type
- EXPERIMENTAL
- label
- Ten Sessions of CBT-I
- interventionNames
- Behavioral: Cognitive Behavioral Therapy for Insomnia
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. The diagnosis of organ-confined BC; 2. Treatment with RT; 3. Willingness and ability to provide informed consent; 4. They endorse problems with both insomnia and CRF, as determined by a score within the significant ranges on the ISI, PROMIS 7a, BFI, and FACIT-F; 5. and/or they do not have any significant medical (e.g., OSA; COPD) and/or psychiatric diagnoses (e.g., PTSD). Exclusion Criteria: 1. History of untreated obstructive sleep apnea (OSA \[defined as an apnea-hypopnea index ≥ 10\]) or above threshold scores on the STOP-BANG; 2. History of narcolepsy; 3. Night shift work; 4. Distant metastatic disease at presentation; 5. Active alcohol and/or drug dependence; 6. They do not have a diagnosis of BC; 7. They do not endorse insomnia, CRF and/or do not score within the significant ranges on the ISI, PROMIS 7a and/or the FACIT; 8. They have a current diagnosis of significant medical and/or psychiatric disorders; 9. And/or they are not between the ages of 25-85 years.
References
Publications (0)
Data not yet available
No reference posted for this study.