Cognitive Behavioral Therapy With or Without Armodafinil in Treating Cancer Survivors With Insomnia and Fatigue After Chemotherapy
Condition: Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Fatigue
Study type: Interventional
Phase: Phase 2

Summary: 
      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: 
      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.
    

Intervention name(s): Quality-of-Life Assessment; Questionnaire Administration; Placebo; Fatigue Assessment and Management; Sleep Disorder Therapy; Armodafinil; Quality-of-life assessment; Questionnaire Administration; Fatigue Assessment and Management; Management of Therapy; Sleep disorder therapy; cognitive assessment; Quality of Life assessment; Questionnaire Administration; Placebo; Fatigue assessment and management; Management of therapy and complications; Sleep disorder therapy; Armodafinil; Cognitive Assessment; Quality of Life Assessment; Questionnaire Administration; Fatifue assessment and management
Intervention type(s): Procedure; Other; Other; Procedure; Procedure; Drug; Procedure; Other; Procedure; Procedure; Procedure; Procedure; Procedure; Other; Other; Procedure; Procedure; Procedure; Drug; Procedure; Procedure; Other; Procedure
Intervention description(s): Ancillary Studies; Ancillary Studies; Given orally; Given orally; Ancillary studies; Ancillary Studies; Ancillary Studies; Ancillary studies; Given orally; Given orally; Quality of Life Assessment; Ancillary Studies
Other intervention name(s): PLCB; Fatigue Assessment/Management; Sleep disorders therapy; Nuvigil; Quality of Life assessment; Fatigue Assessment and Mangement; Complications of therapy management; PLCB; Compllications of therapy management; sleep disorders therapy; Nuvigil; Ancillary studies; Fatigue Assessment/management
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care