Brief Behavioral Intervention for Insomnia During Chemotherapy

Stanford University

Status: Completed

Conditions: Breast Cancer; Insomnia

Treatments: Behavioral: Brief Behavioral Therapy for Insomnia (BBT-I); Behavioral: Healthy Eating Education Learning (HEAL)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02165839

1R01CA181659-01A1 (U.S. NIH Grant/Contract)

BRS0042 (Other Identifier)

IRB-30470

Details and patient eligibility

About

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

Enrollment: 139 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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139 participants in 2 patient groups

Healthy Eating Education Learning (HEAL)

Active Comparator group

Description:

Control group.

Treatment:

Behavioral: Healthy Eating Education Learning (HEAL)

Brief Behavioral Therapy for Insomnia (BBT-I)

Experimental group

Treatment:

Behavioral: Brief Behavioral Therapy for Insomnia (BBT-I)