Cognitive Behavioral Therapy With or Without Armodafinil in Treating Cancer Survivors With Insomnia and Fatigue After Chemotherapy

Study Overview
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Brief Summary
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RATIONALE: Sleep disorder counseling may reduce fatigue and insomnia as well as improve the well-being and quality of life of cancer survivors. Armodafinil may help relieve insomnia and fatigue in patients with cancer after chemotherapy. PURPOSE: This randomized phase II trial is studying how well cognitive behavioral therapy with or without armodafinil works in treating cancer survivors with insomnia and fatigue after chemotherapy.

Detailed Description
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Detailed DescriptionOBJECTIVES: I. To determine if one or more of the intervention strategies (i.e., CBT-I, armodafinil, or both), when compared to a placebo only group, reduce insomnia in cancer patients following the conclusion of chemotherapy and/or radiation therapy. II. To determine if one or more of the intervention strategies (i.e, CBT-I, armodafinil, or both), when compared to a placebo only group, reduce fatigue in cancer patients following the conclusion of chemotherapy and/or radiation therapy. III. To determine if one or more of the intervention strategies (i.e., CBT-I, armodafinil, or both), when compared to a placebo only group, improve QOL in cancer patients following the conclusion of chemotherapy and/or radiation therapy. OUTLINE: Patients are randomized to 1 of 4 treatment arms (cognitive behavioral therapy, armodafinil, both, or neither). After completion of study treatment, patients are followed for 30 days.

Official Title
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Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Procedure: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Other: Placebo
* Procedure: Fatigue Assessment and Management
* Procedure: Sleep Disorder Therapy
* Drug: Armodafinil
* Procedure: Quality-of-life assessment
* Other: Questionnaire Administration
* Procedure: Fatigue Assessment and Management
* Procedure: Management of Therapy
* Procedure: Sleep disorder therapy
* Procedure: cognitive assessment
* Procedure: Quality of Life assessment
* Other: Questionnaire Administration
* Other: Placebo
* Procedure: Fatigue assessment and management
* Procedure: Management of therapy and complications
* Procedure: Sleep disorder therapy
* Drug: Armodafinil
* Procedure: Cognitive Assessment
* Procedure: Quality of Life Assessment
* Other: Questionnaire Administration
* Procedure: Fatifue assessment and management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a diagnosis of cancer Be able to understand written and spoken English Be able to swallow medication Have preferred sleep phase between 7:30 pm and 11:00 am Be willing to discontinue any medications /OTCs/Herbals for sleep for the 11-week study period Be presumed to be in a state of cancer remission; use of tamoxifen, an aromatase inhibitor, and/or Herceptin is permitted Self-report problems with insomnia for at least three months and that the insomnia began or got worse with the onset of cancer or treatment At least one month must have passed since completion of chemotherapy and/or radiation treatment Report insomnia on the SDS-CL at a frequency of at least 3 days a week Exclusion Criteria: Have ever taken modafinil or armodafinil had CBT-I therapy (CBT-I therapy for the sake of this protocol will be defined as any cognitive behavioral-based treatment for insomnia that includes a sleep restriction component) Have an unstable medical or psychiatric illness (Axis I- current or within the last 5 years) Have a history of seizures or severe headaches, or uncontrolled cardiac disease or hypertension Be presently taking an anticoagulant or a corticosteroid Have taken amphetamines (e.g., methylphenidate, pemoline [Cylert] or similar psycho stimulants) within the past 30 days Be currently pregnant or nursing Have a history of substance abuse, or meet criteria for current alcohol abuse or dependence as assessed by a CAGE test score >= 2 or an Alcohol Use Disorders Identification Test (AUDIT) score >= 13 Have surgery planned within the study period Have ever been diagnosed with sleep apnea or have sleep apnea as indicated by endorsing either question 11 (I wake up choking or gasping for air) or question 12 (My bed partner has noticed that I seem to stop breathing) on the Sleep Disorders Symptom Check at the Often or Frequently level Have serious RLS/PLMs indicated by endorsing two or more items associated with RLS/PLMs on the Sleep Disorders Symptom Check at the Frequently level

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

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: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm I<br>Patients receive oral placebo twice daily for 47 days. | Procedure: Quality-of-Life Assessment<br>* Ancillary Studies<br>Other: Questionnaire Administration<br>* Ancillary Studies<br>Other: Placebo<br>* Given orally<br>* Other names: PLCB;Procedure: Fatigue Assessment and Management<br> <br> * Other names: Fatigue Assessment/Management;|
| Experimental: Arm II<br>Patients receive oral armodafinil twice daily for 47 days. | Procedure: Sleep Disorder Therapy<br> <br> * Other names: Sleep disorders therapy;Drug: Armodafinil<br>* Given orally<br>* Other names: Nuvigil;Procedure: Quality-of-life assessment<br>* Ancillary studies<br>* Other names: Quality of Life assessment;Other: Questionnaire Administration<br>* Ancillary Studies<br>Procedure: Fatigue Assessment and Management<br> <br> * Other names: Fatigue Assessment and Mangement;Procedure: Management of Therapy<br> <br> * Other names: Complications of therapy management;|
| Experimental: Arm III<br>Patients receive oral placebo twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia comprising sleep restriction therapy, stimulus control instruction, sleep hygiene guidelines, and a session of cognitive therapy for 7 weeks. | Procedure: Sleep disorder therapy<br> <br> Procedure: cognitive assessment<br> <br> Procedure: Quality of Life assessment<br>* Ancillary Studies<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Placebo<br>* Given orally<br>* Other names: PLCB;Procedure: Fatigue assessment and management<br> <br> Procedure: Management of therapy and complications<br> <br> * Other names: Compllications of therapy management;|
| Experimental: Arm IV<br>Patients receive oral armodafinil twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia as in Arm III for 7 weeks. | Procedure: Sleep disorder therapy<br> <br> * Other names: sleep disorders therapy;Drug: Armodafinil<br>* Given orally<br>* Other names: Nuvigil;Procedure: Cognitive Assessment<br> <br> Procedure: Quality of Life Assessment<br>* Quality of Life Assessment<br>* Other names: Ancillary studies;Other: Questionnaire Administration<br>* Ancillary Studies<br>Procedure: Fatifue assessment and management<br> <br> * Other names: Fatigue Assessment/management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of insomnia as assessed by the insomnia severity index and daily sleeep diaries. |  |  | 
| Fatigue as assessed by the brief fatigue index |  |  | 
| Adverse Events |  | Mid-point and end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue as assessed by the functional assessment of chronic illness therapy-fatigue |  |  | 
| Sleep latency, wake after sleep onset, and total sleep time |  |  |