N/A
Completed N=139
Brief Behavioral Intervention for Insomnia During Chemotherapy
Source: ClinicalTrials.gov NCT02165839 ↗Enrolled (actual)
139
Serious AEs
7.2%
Results posted
Dec 2020
Primary outcomePrimary: Insomnia Severity Index (ISI) — 13.73; 14.93; 11.28; 10.16 score on a scale
Summary
PRIMARY OBJECTIVE(S):
To evaluate the efficacy of the Brief Behavioral Therapy for Insomnia (BBT-I) in treating insomnia among breast cancer patients receiving chemotherapy.
SECONDARY OBJECTIVE(S):
* To evaluate the efficacy of the BBT-I in treating cancer-related symptoms such as cancer-related fatigue and cognitive difficulties in breast cancer patients receiving chemotherapy.
* To examine potential moderators and mediators of BBT-I intervention effects on insomnia, cognitive difficulties, and fatigue. In particular, we are interested in age, depression and anxiety and side effects (hot flashes) as potential moderators of the intervention effects as well as evaluating modifiable behavioral and physiological mechanisms as hypothesized mediators
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insomnia Severity Index (ISI) |
13.73; 14.93; 11.28; 10.16; 9.53; 8.87 | — |
| SECONDARY Brief Fatigue Inventory (BFI) |
4.44; 4.02; 4.32; 3.88; 3.27; 3.00 | — |
| SECONDARY Clinical Assessment of Depression (CAD) |
54.38; 55.44; 53.14; 54.32; 51.15; 51.40 | — |
| SECONDARY Comprehensive Trail Making Test (CTMT) |
44.22; 41.44; 48.68; 45.04; 48.68; 46.53 | — |
| SECONDARY Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Delayed Recall |
49.05; 49.42; 49.06; 46.96; 50.70; 51.68 | — |
| SECONDARY Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Verbal Learning & Memory |
48.94; 50.23; 49.44; 50.42; 53.21; 53.85 | — |
| SECONDARY Controlled Oral Word Association Test (COWAT) |
41.95; 39.51; 42.19; 40.43; 45.72; 43.53 | — |
| SECONDARY Mobile Cognitive Assessment Battery (MCAB) |
— | — |
Eligibility Criteria
INCLUSION CRITERIA
- Female
- Diagnosis of Breast Cancer (Stage I-IIIA)
- Scheduled for planned cancer treatment (eg, chemotherapy or biologic agents), or treatment is continuing
- Has ≥ 6 weeks of cancer treatment (eg, chemotherapy or biologic agents) remaining
- ≥ 21 years of age.
- Able to understand written and spoken English.
- Sleep disturbance of 8 or greater on the ISI, and insomnia that began or got worse with diagnosis of cancer or treatment with chemotherapy (to exclude pre-existing, chronic insomnia).
- Karnofsky score ≥ 70
EXCLUSION CRITERIA
- Have an unstable self-reported medical or psychiatric illness (Axis I - current or within the last 5 years).
- Be currently pregnant or nursing
- History of substance abuse or meet criteria for current alcohol abuse or dependence
- History (self-reported) of sleep apnea or restless leg syndrome (RLS)
- Self-report or have a medical record of an unstable comorbid medical or psychiatric condition that would make it unsafe or impossible to adhere to the study protocol
- Unable or unwilling to discontinue anxiolytics within 4 hours of education sessions
- Irregular heartbeat or arrhythmia (self-reported or in the medical record)
Data sourced from ClinicalTrials.gov (NCT02165839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.