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Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy

Phase 2
21 Years
75 Years
Open (Enrolling)
Insomnia, Fatigue, Breast Cancer

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Trial Information

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collection phase of the study, must have withdrawn from all sleep medications, including: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).

Inclusion Criteria:

1. Have a diagnosis of cancer.

2. Be able to understand written and spoken English

3. Be able to swallow medication

4. Have preferred sleep phase between 7:30 pm and 11:00 am

5. Be willing to discontinue any medications/OTCs/Herbals for sleep for the 11-week
study period

6. Be presumed to be in a state of cancer remission; use of tamoxifen, an aromatase
inhibitor, and/or Herceptin is permitted

7. 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

8. Have completed chemotherapy and or radiation not less than one month ago. Note:
Both types of treatment must be completed at least one month ago if patient receives
chemotherapy and radiation therapy and there is no outer limit to how long ago
treatments were completed.)

9. Report insomnia on the SDS-CL at a frequency of at least 3 days a week

Exclusion Criteria:

1. Have ever taken modafinil or 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.

2. Have an unstable medical or psychiatric illness (Axis I-current or within the last 5

3. Have a history of seizures or severe headaches, or uncontrolled cardiac disease or

4. Be presently taking an anticoagulant or a corticosteroid

5. Have taken amphetamines (e.g., methylphenidate, pemoline [Cylert®] or similar psycho
stimulants) within the past 30 days

6. Be currently pregnant or nursing

7. 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

8. Have surgery planned within the study period

9. Have 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

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.

Outcome Description:

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.

Outcome Time Frame:

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.

Safety Issue:


Principal Investigator

Joseph A Roscoe, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rochester


United States: Institutional Review Board

Study ID:




Start Date:

February 2008

Completion Date:

January 2014

Related Keywords:

  • Insomnia
  • Fatigue
  • Breast Cancer
  • Insomnia
  • Fatigue
  • QOL
  • CBT
  • Breast cancer
  • Survivors
  • Chemotherapy
  • Breast Neoplasms
  • Fatigue
  • Sleep Initiation and Maintenance Disorders



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