Cognitive Behavioral Therapy With or Without Armodafinil in Treating Cancer Survivors With Insomnia and Fatigue After Chemotherapy
NCT01019187 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 226
Last updated 2020-04-09
Summary
RATIONALE: Sleep disorder counseling may reduce fatigue and insomnia as well as improve the well-being and quality of life of cancer survivors. Armodafinil may help relieve insomnia and fatigue in patients with cancer after chemotherapy. PURPOSE: This randomized phase II trial is studying how well cognitive behavioral therapy with or without armodafinil works in treating cancer survivors with insomnia and fatigue after chemotherapy.
Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
Interventions
- PROCEDURE
-
Quality-of-Life Assessment
Ancillary Studies
- OTHER
-
Questionnaire Administration
Ancillary Studies
- OTHER
-
Placebo
Given orally
- PROCEDURE
-
Fatigue Assessment and Management
- PROCEDURE
-
Sleep Disorder Therapy
- DRUG
-
Armodafinil
Given orally
- PROCEDURE
-
Quality-of-life assessment
Ancillary studies
- OTHER
-
Questionnaire Administration
Ancillary Studies
- PROCEDURE
-
Fatigue Assessment and Management
- PROCEDURE
-
Management of Therapy
- PROCEDURE
-
Sleep disorder therapy
- PROCEDURE
-
cognitive assessment
- PROCEDURE
-
Quality of Life assessment
Ancillary Studies
- OTHER
-
Questionnaire Administration
Ancillary studies
- OTHER
-
Placebo
Given orally
- PROCEDURE
-
Fatigue assessment and management
- PROCEDURE
-
Management of therapy and complications
- PROCEDURE
-
Sleep disorder therapy
- DRUG
-
Armodafinil
Given orally
- PROCEDURE
-
Cognitive Assessment
- PROCEDURE
-
Quality of Life Assessment
Quality of Life Assessment
- OTHER
-
Questionnaire Administration
Ancillary Studies
- PROCEDURE
-
Fatifue assessment and management
Sponsors & Collaborators
-
Abramson Cancer Center at Penn Medicine
lead OTHER
Principal Investigators
-
Michael Perlis, MD · Abramson Cancer Center at Penn Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 21 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-06-30
- Primary Completion
- 2013-08-31
- Completion
- 2015-08-31
Countries
- United States
Study Locations
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