Breast Cancer Clinical Trial

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Brief Behavioral Intervention for Insomnia During Chemotherapy

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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

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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)

Study is for people with:

Breast Cancer

Estimated Enrollment:

139

Study ID:

NCT02165839

Recruitment Status:

Completed

Sponsor:

Stanford University

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There is 1 Location for this study

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Stanford University, School of Medicine
Palo Alto California, 94305, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

139

Study ID:

NCT02165839

Recruitment Status:

Completed

Sponsor:


Stanford University

How clear is this clinincal trial information?

Clinical Trial Resources

SurvivorNet’s Guide To Clinical Trials: What Are They And Are They Right for You?
Clinical Trials for Breast Cancer
Have You Been Diagnosed With Late-Stage Breast Cancer? Know That You Have Treatment Options.
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