Cognitive Behavioral Therapy With or Without Armodafinil in Treating Cancer Survivors With Insomnia and Fatigue After Chemotherapy
NCT ID: NCT01019187
Last Updated: 2020-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
226 participants
INTERVENTIONAL
2009-06-30
2015-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Arm I
Patients receive oral placebo twice daily for 47 days.
Quality-of-Life Assessment
Ancillary Studies
Questionnaire Administration
Ancillary Studies
Placebo
Given orally
Fatigue Assessment and Management
Arm II
Patients receive oral armodafinil twice daily for 47 days.
Sleep Disorder Therapy
Armodafinil
Given orally
Quality-of-life assessment
Ancillary studies
Questionnaire Administration
Ancillary Studies
Fatigue Assessment and Management
Management of Therapy
Arm III
Patients receive oral placebo twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia comprising sleep restriction therapy, stimulus control instruction, sleep hygiene guidelines, and a session of cognitive therapy for 7 weeks.
Sleep disorder therapy
cognitive assessment
Quality of Life assessment
Ancillary Studies
Questionnaire Administration
Ancillary studies
Placebo
Given orally
Fatigue assessment and management
Management of therapy and complications
Arm IV
Patients receive oral armodafinil twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia as in Arm III for 7 weeks.
Sleep disorder therapy
Armodafinil
Given orally
Cognitive Assessment
Quality of Life Assessment
Quality of Life Assessment
Questionnaire Administration
Ancillary Studies
Fatifue assessment and management
Interventions
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Quality-of-Life Assessment
Ancillary Studies
Questionnaire Administration
Ancillary Studies
Placebo
Given orally
Fatigue Assessment and Management
Sleep Disorder Therapy
Armodafinil
Given orally
Quality-of-life assessment
Ancillary studies
Questionnaire Administration
Ancillary Studies
Fatigue Assessment and Management
Management of Therapy
Sleep disorder therapy
cognitive assessment
Quality of Life assessment
Ancillary Studies
Questionnaire Administration
Ancillary studies
Placebo
Given orally
Fatigue assessment and management
Management of therapy and complications
Sleep disorder therapy
Armodafinil
Given orally
Cognitive Assessment
Quality of Life Assessment
Quality of Life Assessment
Questionnaire Administration
Ancillary Studies
Fatifue assessment and management
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* At least one month must have passed since completion of chemotherapy and/or radiation treatment
* Report insomnia on the SDS-CL at a frequency of at least 3 days a week
Exclusion Criteria
* 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 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
* Have serious RLS/PLMs indicated by endorsing two or more items associated with RLS/PLMs on the Sleep Disorders Symptom Check at the "Frequently" level
21 Years
75 Years
ALL
No
Sponsors
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Abramson Cancer Center at Penn Medicine
OTHER
Responsible Party
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Principal Investigators
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Michael Perlis, MD
Role: PRINCIPAL_INVESTIGATOR
Abramson Cancer Center at Penn Medicine
Locations
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Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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UPCC 19108
Identifier Type: -
Identifier Source: org_study_id
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