Clinical trial NCT02165839: Brief Behavioral Intervention for Insomnia During Chemotherapy
Official title: Brief Behavioral Intervention for Insomnia During Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Insomnia
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-06-18
Enrollment: 139
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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


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)

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: 12 months
Secondary outcomes:
measure: Brief Fatigue Inventory (BFI)
timeFrame: 12 months
measure: Clinical Assessment of Depression (CAD)
timeFrame: 12 months
measure: Comprehensive Trail Making Test (CTMT)
timeFrame: At baseline, post intervention, 6 months and 12 months
measure: Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Delayed Recall
timeFrame: At baseline, post intervention, 6 months and 12 months
measure: Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Verbal Learning & Memory
timeFrame: At baseline, post intervention, 6 months and 12 months
measure: Controlled Oral Word Association Test (COWAT)
timeFrame: At baseline, post intervention, 6 months and 12 months
measure: Mobile Cognitive Assessment Battery (MCAB)
timeFrame: At baseline, post intervention, 6 months and 12 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Oxana Palesh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woldeamanuel YW, Blayney DW, Jo B, Fisher SE, Benedict C, Oakley-Girvan I, Kesler SR, Palesh O. Headache outcomes of a sleep behavioral intervention in breast cancer survivors: Secondary analysis of a randomized clinical trial. Cancer. 2021 Dec 1;127(23):4492-4503. doi: 10.1002/cncr.33844. Epub 2021 Aug 6.