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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: Completed Phase 2 study of Insomnia and Fatigue, sponsored by Stanford University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Insomnia Severity Index (ISI) survey questionnaire is a 7-question survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. The full range of ISI scores is from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia. Clinical interpretation is as follows. * 0 to 7 No clinically significant insomnia * 8 to14 Subthreshold insomnia
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 |
What the finished NCT01011218 record still lists
NCT01011218 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (59% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Insomnia
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 NCT01011218's enrollment target sits among peer trials
70 85th of 151 higher than 65 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia 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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