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

• Severity of insomnia as assessed by the insomnia severity index and daily sleeep diaries. [ Designated as safety issue: No ]
• Fatigue as assessed by the brief fatigue index [ Designated as safety issue: No ]
• Adverse Events [ Time Frame: Mid-point and end of treatment ] [ Designated as safety issue: Yes ]

• Severity of insomnia as assessed by the insomnia severity index and daily sleeep diaries. [ Time Frame: N?A ] [ Designated as safety issue: No ]
• Fatigue as assessed by the brief fatigue index [ Designated as safety issue: No ]
• Adverse Events [ Time Frame: Mid-point and end of treatment ] [ Designated as safety issue: Yes ]

• Fatigue as assessed by the functional assessment of chronic illness therapy-fatigue [ Designated as safety issue: No ]
• Sleep latency, wake after sleep onset, and total sleep time [ Designated as safety issue: No ]

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 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.

• Procedure: Quality-of-Life Assessment
  Ancillary Studies
• Other: Questionnaire Administration
  Ancillary Studies
• Other: Placebo
  Given orally
  Other Name: PLCB
• Procedure: Fatigue Assessment and Management
  Other Name: Fatigue Assessment/Management
• Procedure: Sleep Disorder Therapy
  Other Name: Sleep disorders therapy
• Drug: Armodafinil
  Given orally
  Other Name: Nuvigil
• Procedure: Quality-of-life assessment
  Ancillary studies
  Other Name: Quality of Life assessment
• Procedure: Fatigue Assessment and Management
  Other Name: Fatigue Assessment and Mangement
• Procedure: Management of Therapy
  Other Name: Complications of therapy management
• Procedure: Sleep disorder therapy
  Other Name: sleep disorder therapy
• Procedure: cognitive assessment
• Procedure: Quality of Life assessment
  Ancillary Studies
• Other: Questionnaire Administration
  Ancillary studies
• Procedure: Fatigue assessment and management
  Other Name: Fatigue Assessment and management
• Procedure: Management of therapy and complications
  Other Name: Compllications of therapy management
• Procedure: Sleep disorder therapy
  Other Name: sleep disorders therapy
• Procedure: Cognitive Assessment
• Procedure: Quality of Life Assessment
  Quality of Life Assessment
  Other Name: Ancillary studies
• Procedure: Fatifue assessment and management
  Other Name: Fatigue Assessment/management

• Placebo Comparator: Arm I
  Patients receive oral placebo twice daily for 47 days.
  Interventions:

  • Procedure: Quality-of-Life Assessment
  • Other: Questionnaire Administration
  • Other: Placebo
  • Procedure: Fatigue Assessment and Management
• Experimental: Arm II
  Patients receive oral armodafinil twice daily for 47 days.
  Interventions:

  • Procedure: Sleep Disorder Therapy
  • Drug: Armodafinil
  • Procedure: Quality-of-life assessment
  • Other: Questionnaire Administration
  • Procedure: Fatigue Assessment and Management
  • Procedure: Management of Therapy
• Experimental: Arm III
  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.
  Interventions:

  • 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
• Experimental: Arm IV
  Patients receive oral armodafinil twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia as in Arm III for 7 weeks.
  Interventions:

  • Procedure: Sleep disorder therapy
  • Drug: Armodafinil
  • Procedure: Cognitive Assessment
  • Procedure: Quality of Life Assessment
  • Other: Questionnaire Administration
  • Procedure: Fatifue assessment and management

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