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

Tracking Information
First Submitted Date ICMJE	December 9, 2009
First Posted Date ICMJE	March 24, 2010
Results First Submitted Date	February 5, 2015
Results First Posted Date	March 13, 2015
Last Update Posted Date	February 9, 2017
Study Start Date ICMJE	February 2008
Actual Primary Completion Date	April 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 11, 2015)	Change in Insomnia Severity Index From Baseline to Post-intervention [ Time Frame: ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre). ]; The Insomnia Severity Index (ISI) is a commonly used, 7-item psychometrically validated measure used to rate insomnia with 0-7 = absence of insomnia, 8-14 = subthreshold insomnia symptoms, 15-21 = moderate insomnia, and 22-28 = severe insomnia.
Original Primary Outcome Measures ICMJE; (submitted: March 22, 2010)	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. [ 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. ]
Change History	Complete list of historical versions of study NCT01091974 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 16, 2016)	Fatigue Will be Assessed by the Total Score of the Revised Brief Fatigue Inventory (BFI) . [ Time Frame: ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre). ]; The revised Brief Fatigue Inventory (BFI) is a 9-item, patient-report instrument with established reliability and validity. The BFI allows for the rapid assessment of fatigue level in cancer patients and identifies those patients with severe fatigue. Three items ask patients to rate their fatigue "now," and fatigue at its "worst" and "usual" for the last 24 hours. The 11-point scales are bounded by 0 = "no fatigue" and 10 = "fatigue as bad as you can imagine." Using the same type of scales, the remaining questions ask patients to rate how their fatigue interferes with several functional domains, including general activity, walking, mood, work, and relations with others. These scales are bounded by 0 = "does not interfere" and 10 = "interferes completely." A global fatigue score (ranging from 0-10) can be obtained by averaging all the items on the BFI.
Original Secondary Outcome Measures ICMJE; (submitted: March 22, 2010)	All three intervention strategies, as compared to the placebo only group, will reduce fatigue in patients, where the largest effects will occur with the two conditions that utilize armodafinil. [ Time Frame: Fatigue will be assessed by the total score of the revised Brief Fatigue Inventory (BFI) which will be completed every Friday during weeks 3-11 of the study and again during weeks 23 and 24. ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy
Official Title ICMJE	Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy
Brief Summary	This is a four-arm, randomized, controlled, clinical trial examining the efficacy of of cognitive behavioral therapy (CBT)-I and armodafinil in reducing insomnia in 226 female breast cancer patients who report sleep disturbances following completion of chemotherapy.
Detailed Description	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 in cancer survivors. Assessments will be made by questionnaires before, during, and two weeks 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 the Insomnia Severity (ISI) at the time of consent and every Friday during weeks 3-11 of the study. 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 Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Supportive Care
Condition ICMJE	Insomnia; Fatigue; Breast Cancer
Intervention ICMJE	Drug: armodafinil Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg); Drug: Placebo Comparator Placebo for 47 days; Behavioral: CBT-I Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)
Study Arms	Experimental: 1 - CBT-I + placebo CBT-I and placebo Interventions: Drug: Placebo Comparator Behavioral: CBT-I; Experimental: 2 - CBT-I + Armodafinil CBT-I + Armodafinil Interventions: Drug: armodafinil Behavioral: CBT-I; Placebo Comparator: 3 - Placebo only Placebo only Intervention: Drug: Placebo Comparator; Experimental: 4 - Armodafinil only Armodafinil only Intervention: Drug: armodafinil
Publications *	Roscoe JA, Garland SN, Heckler CE, Perlis ML, Peoples AR, Shayne M, Savard J, Daniels NP, Morrow GR. Randomized placebo-controlled trial of cognitive behavioral therapy and armodafinil for insomnia after cancer treatment. J Clin Oncol. 2015 Jan 10;33(2):165-71. doi: 10.1200/JCO.2014.57.6769. Epub 2014 Dec 1.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: March 11, 2015)	138
Original Estimated Enrollment ICMJE; (submitted: March 22, 2010)	226
Actual Study Completion Date	April 2013
Actual Primary Completion Date	April 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Have a diagnosis of cancer.; Be able to understand written and spoken English; Be able to swallow medication; Have preferred sleep phase between 7:30 pm and 11:00 am; Be willing to discontinue any medications/OTCs/Herbals for sleep for the 11-week study period; Be presumed to be in a state of cancer remission; use of tamoxifen, an aromatase inhibitor, and/or Herceptin is permitted; 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; 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.); Report insomnia on the SDS-CL at a frequency of at least 3 days a week Exclusion Criteria: 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.; Have an unstable medical or psychiatric illness (Axis I-current or within the last 5 years); Have a history of seizures or severe headaches, or uncontrolled cardiac disease or hypertension; Be presently taking an anticoagulant or a corticosteroid; Have taken amphetamines (e.g., methylphenidate, pemoline [Cylert®] or similar psycho stimulants) within the past 30 days; Be currently pregnant or nursing; 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; Have surgery planned within the study period; 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.
Sex/Gender	Sexes Eligible for Study: All
Ages	21 Years to 75 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01091974
Other Study ID Numbers ICMJE	UCCS07090; 1R01CA126968-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Joseph Roscoe, University of Rochester
Study Sponsor ICMJE	University of Rochester
Collaborators ICMJE	National Cancer Institute (NCI)
Investigators ICMJE	Principal Investigator: Joseph A Roscoe, PhD University of Rochester
PRS Account	University of Rochester
Verification Date	December 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP