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NCT01011218 · ClinicalTrials.gov registry record · Phase 2
Management of Insomnia in Breast Cancer Patients
A Phase 2 study of Insomnia and Fatigue, sponsored by Stanford University.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT01011218 is a Phase 2 study of Insomnia and Fatigue that has completed, run by Stanford University. The registered enrollment target is 70 participants, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01011218, a Phase 2 study of Insomnia and Fatigue, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
To provide preliminary data on the effects of brief behavioral therapy for insomnia (BBT-I) on insomnia in breast cancer patients expecting to receive cancer treatment (unspecified). Participants will be randomized into 4 groups: * Arm 1: Brief Behavioral Treatment of Insomnia (BBT-I) + Armodafinil 150 mg/day. * Arm 2: Behavioral therapy for insomnia (CBT-I) + Armodafinil 150 mg/day. * Arm 3: Brief Behavioral Treatment of Insomnia (BBT-I) without pharmaceutical intervention. * Arm 4: Behavioral therapy for insomnia (CBT-I) without pharmaceutical intervention.
Interventions
- BEHAVIORAL Control
- DRUG Armodafinil
- BEHAVIORAL BBT-I
Study Locations (1)
California
- Stanford University - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2011-01 |
| Est. Completion | 2016-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01011218
The ClinicalTrials.gov registry entry for NCT01011218 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (59% lower). The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Insomnia appearing as the primary indexed condition, and to 3 interventions - of which Control is the first listed.
NCT01011218 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT01011218 about?
NCT01011218 is a clinical study titled "Management of Insomnia in Breast Cancer Patients". To provide preliminary data on the effects of brief behavioral therapy for insomnia (BBT-I) on insomnia in breast cancer patients expecting to receive cancer treatment (unspecified). Participants will be randomized into 4 groups: * Arm 1: Brief Behavioral Treatment of Insomnia (BBT-I) + Armodafini...
What is the current status of trial NCT01011218?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2011-01. Estimated completion is 2016-07.
What conditions does trial NCT01011218 study?
This clinical trial studies the following conditions: Insomnia, Fatigue.
What interventions are being tested in trial NCT01011218?
The interventions under investigation include: Control (BEHAVIORAL), Armodafinil (DRUG), BBT-I (BEHAVIORAL).
Who is sponsoring clinical trial NCT01011218?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01011218 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.