Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

Breast Cancer

Interventions

  • BEHAVIORAL Cognitive Behavioral Stress Management (CBSM)

Study Locations (1)

Washington

  • Fred Hutchinson Cancer Research Center - Seattle

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2009-07
Est. Completion 2012-02
Phase Phase 2

Sponsor

Fred Hutchinson Cancer Center

483 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01048528

The ClinicalTrials.gov registry entry for NCT01048528 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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

Similar trials for Breast Cancer

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.

Explore more on PlainTrial

Breast Cancer

All registered trials for this condition

Washington

All trials with a study site in Washington

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.