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NCT01628029 · ClinicalTrials.gov registry record · Phase 2
Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer
A Phase 2 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
- 1
- Study location
NCT01628029: Active Phase 2 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by M.D. Anderson Cancer Center.
NCT01628029 is a Phase 2 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 68 participants, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01628029, a Phase 2 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
- 1
- Study location
Study Summary
This randomized phase II trial studies how well cognitive behavioral therapy and multimodal therapy works in treating sleep disturbance in patients with cancer. Cognitive behavioral therapy may help reduce sleep disturbances, fatigue, and insomnia as well as improve the well-being and quality of life of patients with cancer when given together with methylphenidate hydrochloride, therapeutic melatonin, and light therapy.
Primary Outcome
PSQI consists of 19 items, and it measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component score ranges from 0 (no difficulty/good) to 3 (severe difficulty/poor). The global PSQI score is then calculated by totaling (summed) seven component scores, pr
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- PROCEDURE Phototherapy
- OTHER Counseling
- OTHER Placebo Administration
- DRUG Methylphenidate Hydrochloride
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2014-01-15 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
What the registry record for NCT01628029 still lists
NCT01628029 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (94% lower).
The record links to 3 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT01628029 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01628029 about?
NCT01628029 is a clinical study titled "Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer". This randomized phase II trial studies how well cognitive behavioral therapy and multimodal therapy works in treating sleep disturbance in patients with cancer. Cognitive behavioral therapy may help reduce sleep disturbances, fatigue, and insomnia as well as improve the well-being and quality of lif...
What is the current status of trial NCT01628029?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2014-01-15. Estimated completion is 2028-12-31.
What conditions does trial NCT01628029 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Sleep Disorder.
What interventions are being tested in trial NCT01628029?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Phototherapy (PROCEDURE), Counseling (OTHER), Placebo Administration (OTHER), Methylphenidate Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01628029?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01628029 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01628029's enrollment target sits among peer trials
68 113th of 176 higher than 64 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Neoplasm 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.
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