Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy
Treatment Protocol: CBT-I and armodafinil are being studied in a four-arm, randomized,
controlled, clinical trial of 226 cancer survivors with chronic insomnia who are at least
one month post treatment. The seven-week intervention is designed to determine the efficacy
and acceptability of these treatment strategies in reducing insomnia and fatigue and in
improving QOL in cancer survivors. Assessments will be made by diary and by questionnaires
before, during, two weeks following, and three months following the study intervention. All
ancillary treatments, as appropriate for control of symptoms caused by the cancer or its
treatment may be administered as clinically indicated.
Withdrawal of Sleep Medications: All participants, prior to beginning the baseline data
collection phase of the study, must have withdrawn from all sleep medications, including:
prescription, over-the-counter, CAM and herbal remedies for at least one week prior to
beginning the study.
CBT-I (Arms 3 & 4): CBT-I will be provided on an individual basis to all patients in study
Arms 3 & 4 by a licensed clinical psychologist trained in CBT-I by Dr. Perlis. Subjects in
these two study arms will receive 7 weeks of CBT-I, using a structured research grade
protocol developed at the UR-SNRL. This manualized intervention, which exists as a published
text: Perlis et al., 2005, includes four essential components: Sleep Restriction Therapy,
Stimulus Control Instruction, Sleep Hygiene Guidelines, and a session of cognitive therapy.
Data Collection: Patients will complete assessments i.e., ESS/KSS, ISI, BFI, FACIT, PHQ-9,
GODIN, and Medical Symptoms every Friday during weeks 3-11 of the study and again during
weeks 23 and 24. In addition, the IDS will be completed on Fridays during weeks 9, 11, and
24 and patients will complete the PSQI, medication log, and feedback questionnaire on
Fridays during weeks 11, and 24. A follow-up call by study personnel will be made to each
participant not currently receiving CBT-I on each of these Fridays to promote compliance,
prompt completion, assess potential side effects of study medication, and answer patient
questions. Study participants will also be required to maintain a daily sleep diary for the
initial 11 weeks of the study (i.e., baseline, intervention, and post period) and for two
weeks at follow-up (Weeks 23 and 24).
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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 breast cancer patients following the conclusion of chemotherapy.
The primary analysis will use longitudinal models with treatment condition, time, and time by treatment condition as predictors and insomnia severity as the dependent variable.
Severity of insomnia will be assessed by the total score of the Severity Index (ISI) which will be completed every Friday during weeks 3-11 of the study and again during weeks 23 and 24.
Joseph A Roscoe, PhD
University of Rochester
United States: Institutional Review Board
|University of Rochester James P. Wilmot Cancer Center||Rochester, New York 14642|
|Behavioral Sleep Medicine Program, Department of Psychiatry, University of Pennsylvania||Philadelphia, Pennsylvania 19104|