NCT01019187

Cognitive Behavioral Therapy With or Without Armodafinil in Treating Cancer Survivors With Insomnia and Fatigue After Chemotherapy

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 226 (estimated)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Detailed DescriptionOBJECTIVES: 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

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-06-01
• Primary completion: 2013-08-01
• Completion: 2015-08-01
• First posted: 2009-11-24
• Last updated: 2020-04-09

Locations

1 site across 1 country: United States