Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following 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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Severity of insomnia as assessed by the insomnia severity index and daily sleeep diaries.
No
United States: Institutional Review Board
UPCC 19108
NCT01019187
June 2009
June 2013
Name | Location |
---|---|
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |