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NCT01048528 · ClinicalTrials.gov registry record · Phase 2
Health SMART (Stress Management and Relaxation Training)
A Phase 2 study of Breast Cancer, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT01048528: Completed Phase 2 study of Breast Cancer, sponsored by Fred Hutchinson Cancer Center.
NCT01048528 is a Phase 2 study of Breast Cancer that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 33 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01048528, a Phase 2 study of Breast Cancer, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study Summary
The study will examine the effects of a cognitive behavioral stress management (CBSM) group intervention on antibody and cellular immune function among women who are at elevated risk for breast cancer because of family history. Hypothesis 1: Women who participate in the CBSM intervention will have a larger primary and secondary antibody response to HA vaccine compared to women in the comparison group. Hypothesis 2: In response to stimulation with HA antigen, lymphocytes from women who participate in the CBSM intervention will have larger primary and secondary in-vitro proliferative response to HA antigen, and increased primary and secondary in-vitro TH1 cytokine response to HA antigen compared to lymphocytes from women in the comparison group. Hypothesis 3: Women who participate in the 10-week CBSM group intervention will report lower levels of distress immediately after the intervention compared to women in the comparison group. Changes in distress as a result of the intervention will be associated with any significant changes in immune function discovered in Aims 1 and 2.
Conditions Studied
Interventions
- BEHAVIORAL Cognitive Behavioral Stress Management (CBSM)
Study Locations (1)
Washington
- Fred Hutchinson Cancer Research Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2009-07 |
| Est. Completion | 2012-02 |
| Phase | Phase 2 |
What the finished NCT01048528 record still lists
NCT01048528 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Cognitive Behavioral Stress Management (CBSM) is the first listed.
NCT01048528 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT01048528 about?
NCT01048528 is a clinical study titled "Health SMART (Stress Management and Relaxation Training)". The study will examine the effects of a cognitive behavioral stress management (CBSM) group intervention on antibody and cellular immune function among women who are at elevated risk for breast cancer because of family history. Hypothesis 1: Women who participate in the CBSM intervention will have ...
What is the current status of trial NCT01048528?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2009-07. Estimated completion is 2012-02.
What conditions does trial NCT01048528 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT01048528?
The interventions under investigation include: Cognitive Behavioral Stress Management (CBSM) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01048528?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01048528 being conducted?
This trial has 1 study location across Washington. 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 NCT01048528's enrollment target sits among peer trials
33 935th of 1224 higher than 285 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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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