Management of Insomnia in Breast Cancer Patients

Study Overview
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Brief Summary
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To provide preliminary data on the effects of brief behavioral therapy for insomnia (BBT-I) on insomnia in breast cancer patients expecting to receive cancer treatment (unspecified). Participants will be randomized into 4 groups: Arm 1: Brief Behavioral Treatment of Insomnia (BBT-I) + Armodafinil 150 mg/day. Arm 2: Behavioral therapy for insomnia (CBT-I) + Armodafinil 150 mg/day. Arm 3: Brief Behavioral Treatment of Insomnia (BBT-I) without pharmaceutical intervention. Arm 4: Behavioral therapy for insomnia (CBT-I) without pharmaceutical intervention.

Detailed Description
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The purpose of this study is to test the efficacy of Brief Behavioral Treatment of Insomnia (BBT-I) in the treatment of insomnia in humans. Insomnia is an extraordinarily common problem for cancer patients that is often associated with diminished social and vocational functioning and QOL. It is also likely that insomnia exacerbates other cancer-related symptoms (eg, fatigue, nausea, depressive mood, pain and/or reduced pain tolerance) and thus gives rise to the possibility of additive or multiplicative interactions. It is possible that untreated insomnia in the context of cancer therapy may lead to chronic forms of insomnia in cancer survivors which, in turn, independently confers risk for increased psychiatric and medical morbidity. Thus, insomnia, by itself, is a significant problem that requires better understanding in order that its high prevalence can be reduced. Developing interventions that might prevent onset of insomnia in breast cancer patients is vital.

Official Title
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Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study

Conditions
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Fatigue, Insomnia

Intervention / Treatment
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* Behavioral: BBT-I
* Behavioral: Control
* Drug: Armodafinil


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA Be scheduled for cancer treatment with chemotherapy or biologics (prior chemotherapy and/or diagnosis of metastatic breast are allowed) Have at least 6 weeks of treatment remaining ≥ 21 years old Able to understand written and spoken English Able to swallow medication (until amendment omitting armodafinil treatment) Score of 3+ on the Sleep Disruption Evaluation form, OR a score of 8+ on Insomnia Severity Index (ISI) EXCLUSION CRITERIA Prior treatment with armodafinil or modafinil (until amendment omitting armodafinil treatment) Prior treatment with psycho-stimulant medication within the past 28 days (until amendment omitting armodafinil treatment) Prior treatment with antiseizure medications (until amendment omitting armodafinil treatment) Has continuously taken sleep medication daily for the last 28 days (until amendment omitting armodafinil treatment) History (self-reported) of unstable medical or psychiatric illness (within the last 5 years) History of uncontrolled, cardiac disease, hypertension, severe headaches, glaucoma, or seizures (until amendment omitting armodafinil treatment) Pregnant or nursing History of substance abuse or meet criteria for current alcohol abuse or dependence History (self-reported) of chronic, preexisting insomnia, sleep apnea, or restless leg syndrome (RLS) Severe hepatic impairment (until amendment omitting armodafinil treatment)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BBT-I + Armodafinil<br>Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. Armodafinil 150 mg/day by mouth. | Behavioral: BBT-I<br>* Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone<br>* Other names: Brief Behavioral Intervention for Insomnia;Drug: Armodafinil<br>* 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.<br>* Other names: Nuvigil;|
| Experimental: Behavioral placebo + Armodafinil<br>Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth. | Behavioral: Control<br>* Control behavioral intervention is a sleep hygiene handout completed by participant.<br>* Other names: Behavioral placebo;Drug: Armodafinil<br>* 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.<br>* Other names: Nuvigil;|
| Sham Comparator: BBT-I without Armodafinil<br>Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. No pharmaceutical intervention. | Behavioral: BBT-I<br>* Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone<br>* Other names: Brief Behavioral Intervention for Insomnia;|
| Placebo Comparator: Behavioral placebo without Armodafinil<br>Control behavioral intervention is a sleep hygiene handout completed by participant. No pharmaceutical intervention. | Behavioral: Control<br>* Control behavioral intervention is a sleep hygiene handout completed by participant.<br>* Other names: Behavioral placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index (ISI) | Insomnia Severity Index (ISI) survey questionnaire is a 7-question survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. The full range of ISI scores is from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia. Clinical interpretation is as follows. 0 to 7 No clinically significant insomnia 8 to14 Subthreshold insomnia 15 to 21 Clinical insomnia (moderate severity) 22 to 28 Clinical insomnia (severe) ISI survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean ISI score with standard deviation. | up to 32 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) survey questionnaire is a 13-question subset of the 41-question Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire, with each question having 5 possible answers (not at all; a little bit; somewhat; quite a bit; very much), scored as 0, 1, 2, 3, or 4, respectively. The full range of FACIT-Fatigue scores is from 0 to 52. Higher scores are considered good, better, or healthy, and increasingly lower scores are considered to indicate greater fatigue. The FACIT-Fatigue survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean with standard deviation. | up to 32 Weeks |