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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Joseph Roscoe, University of Rochester
ClinicalTrials.gov Identifier:
NCT01091974
First received: December 9, 2009
Last updated: August 4, 2015
Last verified: August 2015
Results First Received: February 5, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions: Insomnia
Fatigue
Breast Cancer
Interventions: Drug: armodafinil
Drug: Placebo Comparator
Behavioral: CBT-I

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
138 Patients were consented of which 114 were eligible.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
18 Withdrew prior to randomization (3 ceased responding to contacts, 4 changed mind , 3 began or restarted sleep medication, 4 did not complete baseline measures, 1 did not receive approval from physician to participate, 1 found the diaries too much trouble, 1 did not want to take study medication, and 1 had a family emergency).

Reporting Groups
  Description
Arm 1 - (CBT-I) + Placebo

Placebo Comparator: Placebo for 47 days

CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)

2 - CBT-I + Armodafinil

Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)

CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)

3- Placebo Only Placebo Comparator: Placebo for 47 days
4 - Armodafinil Only Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)

Participant Flow:   Overall Study
    Arm 1 - (CBT-I) + Placebo     2 - CBT-I + Armodafinil     3- Placebo Only     4 - Armodafinil Only  
STARTED     24     23     25     24  
COMPLETED     19     18     19     17  
NOT COMPLETED     5     5     6     7  
Did not start intervention                 3                 1                 3                 1  
resumed sleep medication                 0                 0                 1                 2  
Withdrawal by Subject                 1                 3                 2                 2  
side-effects                 1                 1                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1 - CBT-I + Placebo

CBT-I and placebo

Placebo Comparator: Placebo for 47 days

CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)

2 - CBT-I + Armodafinil

CBT-I + Armodafinil

armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)

CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)

3 - Placebo Only

Placebo only

Placebo Comparator: Placebo for 47 days

4 - Armodafinil Only

Armodafinil only

armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)

Total Total of all reporting groups

Baseline Measures
    1 - CBT-I + Placebo     2 - CBT-I + Armodafinil     3 - Placebo Only     4 - Armodafinil Only     Total  
Number of Participants  
[units: participants]
  24     23     25     24     96  
Age  
[units: years]
Mean (Standard Deviation)
  59  (9.9)     56  (10.2)     52  (11.5)     57  (7.4)     56.1  (10.0)  
Gender  
[units: participants]
         
Female     21     22     18     23     84  
Male     3     1     7     1     12  
Ethnicity (NIH/OMB)  
[units: participants]
         
Hispanic or Latino     0     0     0     0     0  
Not Hispanic or Latino     23     22     24     22     91  
Unknown or Not Reported     1     1     1     2     5  
Race (NIH/OMB)  
[units: participants]
         
American Indian or Alaska Native     0     0     0     0     0  
Asian     0     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0  
Black or African American     1     2     4     1     8  
White     23     21     19     23     86  
More than one race     0     0     0     0     0  
Unknown or Not Reported     0     0     2     0     2  
Region of Enrollment  
[units: participants]
         
United States     24     23     25     24     96  



  Outcome Measures

1.  Primary:   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). ]

2.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   04/2016   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Joseph A. Roscoe Ph.D.
Organization: University of Rochester Medical Center
phone: (585) 275-9962
e-mail: Joseph_Roscoe@URMC.Rochester.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Joseph Roscoe, University of Rochester
ClinicalTrials.gov Identifier: NCT01091974     History of Changes
Other Study ID Numbers: UCCS07090
1R01CA126968-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: December 9, 2009
Results First Received: February 5, 2015
Last Updated: August 4, 2015
Health Authority: United States: Institutional Review Board