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NCT01019187 · ClinicalTrials.gov registry record · Phase 2
Cognitive Behavioral Therapy With or Without Armodafinil in Treating Cancer Survivors With Insomnia and Fatigue After Chemotherapy
A Phase 2 study of Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Abramson Cancer Center at Penn Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 226
- Enrollment target
- 1
- Study location
NCT01019187 is a Phase 2 study of Unspecified Adult Solid Tumor, Protocol Specific that has completed, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 226 participants, below the 498-participant average among 83 other Unspecified Adult Solid Tumor, Protocol Specific trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01019187, a Phase 2 study of Unspecified Adult Solid Tumor, Protocol Specific, has completed, sponsored by Abramson Cancer Center at Penn Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 226 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- OTHER Placebo
- OTHER Questionnaire Administration
- PROCEDURE Quality-of-Life Assessment
- PROCEDURE Fatigue Assessment and Management
- PROCEDURE Sleep Disorder Therapy
Study Locations (1)
Pennsylvania
- Abramson Cancer Center of the University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 226 participants |
| Start Date | 2009-06 |
| Est. Completion | 2015-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01019187
The ClinicalTrials.gov registry entry for NCT01019187 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 226 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 498-participant average among 83 other Unspecified Adult Solid Tumor, Protocol Specific trials with a reported enrollment target (55% lower). The listed sponsor is Abramson Cancer Center at Penn Medicine, which has 402 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Unspecified Adult Solid Tumor, Protocol Specific appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT01019187 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01019187 about?
NCT01019187 is a clinical study titled "Cognitive Behavioral Therapy With or Without Armodafinil in Treating Cancer Survivors With Insomnia and Fatigue After Chemotherapy". 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 c...
What is the current status of trial NCT01019187?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 226 participants. The study started on 2009-06. Estimated completion is 2015-08.
What conditions does trial NCT01019187 study?
This clinical trial studies the following conditions: Unspecified Adult Solid Tumor, Protocol Specific.
What interventions are being tested in trial NCT01019187?
The interventions under investigation include: Placebo (OTHER), Questionnaire Administration (OTHER), Quality-of-Life Assessment (PROCEDURE), Fatigue Assessment and Management (PROCEDURE), Sleep Disorder Therapy (PROCEDURE).
Who is sponsoring clinical trial NCT01019187?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01019187 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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