Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy
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.
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