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NCT00121160 · ClinicalTrials.gov registry record · Phase 1
Health SMART (Stress Management and Relaxation Training) to Improve Vaccine Immune Response
A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 126
- Enrollment target
NCT00121160 is a Phase 1 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 126 participants.
The verdict
NCT00121160, a Phase 1 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 126 participants
- Enrollment target
Study Summary
The proposed investigation will conduct a randomized, clinical trial to test the efficacy of a cognitive behavioral stress management (CBSM) group intervention on immune response to vaccine and distress among women at elevated risk for breast cancer. Hypothesis 1: Women who participate in the CBSM intervention will have a larger primary and secondary antibody response to vaccines compared to women in the comparison group. Hypothesis 2: Women who participate in a 10-week CBSM group intervention will report lower levels of distress immediately after and 6 months after the intervention compared to women in the comparison group.
Interventions
- BEHAVIORAL Cognitive Behavioral Stress Management (CBSM) group intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2005-09 |
| Est. Completion | 2010-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00121160
The ClinicalTrials.gov registry entry for NCT00121160 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cognitive Behavioral Stress Management (CBSM) group intervention is the first listed.
NCT00121160 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00121160 about?
NCT00121160 is a clinical study titled "Health SMART (Stress Management and Relaxation Training) to Improve Vaccine Immune Response". The proposed investigation will conduct a randomized, clinical trial to test the efficacy of a cognitive behavioral stress management (CBSM) group intervention on immune response to vaccine and distress among women at elevated risk for breast cancer. Hypothesis 1: Women who participate in the CBSM ...
What is the current status of trial NCT00121160?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 126 participants. The study started on 2005-09. Estimated completion is 2010-07.
What interventions are being tested in trial NCT00121160?
The interventions under investigation include: Cognitive Behavioral Stress Management (CBSM) group intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT00121160?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
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