Brief Behavioral Intervention for Insomnia During Chemotherapy
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Insomnia Sleep Studies |
| Therapuetic Areas: | Oncology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 2/27/2019 |
| Start Date: | January 2015 |
| End Date: | January 2020 |
PRIMARY OBJECTIVE(S):
The purpose of this study is to test the efficacy of brief behavioral therapy versus control
condition that accounts for time and attention (nutrition education) in the treatment of
insomnia in humans.
SECONDARY OBJECTIVE(S):
To assess the impact of different biomarkers on sleep disruption and other patient reported
outcomes
The purpose of this study is to test the efficacy of brief behavioral therapy versus control
condition that accounts for time and attention (nutrition education) in the treatment of
insomnia in humans.
SECONDARY OBJECTIVE(S):
To assess the impact of different biomarkers on sleep disruption and other patient reported
outcomes
Inclusion Criteria:
- Be female and have a diagnosis of Breast Cancer (Stage I-IIIA).
- Be scheduled for planned cancer treatment (e.g. chemotherapy or biologics such as
herceptin).
- Have at least 6 weeks of cancer treatment (e.g. chemotherapy or biologics such as
herceptin) remaining.
- Be at least 21 years of age.
- Be able to understand written and spoken English.
- Report sleep disturbance of 8 or greater on the ISI, and report insomnia that began or
got worse with diagnosis of cancer or treatment with chemotherapy (to exclude
pre-existing, chronic insomnia).
- Have a Karnofsky score >= 70 to ensure that patients are able to participate in
intervention and assessments.
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 (patients are monitored for pregnancy during
chemotherapy and pregnant women in the first trimester are not administered
chemotherapy. Therefore, pregnancy status of women will be known prior to the entrance
to the study).
- Have a history of substance abuse or meet criteria for current alcohol abuse or
dependence
- Have a self-reported history 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
- Are unable or unwilling to discontinue anxiolytics within 4 hours of education
sessions
- Have irregular heartbeats or arrhythmia (self-reported or in the medical record)
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