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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: Completed Phase 2 study of Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Abramson Cancer Center at Penn Medicine.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

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

FieldValue
Enrollment Target 226 participants
Start Date 2009-06
Est. Completion 2015-08
Phase Phase 2

What the finished NCT01019187 record still lists

NCT01019187 is an interventional study that assigns participants to a tested intervention. The registered 226 participants enrollment target is mid-sized for trials with a published cap, below the 498-participant average among 83 other Unspecified Adult Solid Tumor, Protocol Specific trials with a reported enrollment target (55% lower).

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 a single indexed study location in 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.

Similar trials for Unspecified Adult Solid Tumor, Protocol Specific

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01019187's enrollment target sits among peer trials

226 13th of 83 higher than 71 of 83 other Unspecified Adult Solid Tumor, Protocol Specific trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Unspecified Adult Solid Tumor, Protocol Specific trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01019187, the US trial registry maintained by the National Library of Medicine. NCT01019187 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.