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Health SMART (Stress Management and Relaxation Training)

NCT01048528 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2012-03-27

No results posted yet for this 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

Interventions

BEHAVIORAL

Cognitive Behavioral Stress Management (CBSM)

The intervention employs CBSM techniques interwoven with information in a supportive group format. The information portion of the intervention focuses on learning to cope with daily stressors, and learning about optimal use of social support. Avoidance coping is discouraged, and acceptance and reframing are instead encouraged as coping responses. Health behavior change, framed as a coping technique, will also be discussed using motivational interviewing techniques. Relaxation techniques include progressive muscle relaxation, guided imagery, autogenics, meditation, and deep breathing. The goal of the CBSM intervention is thus to reduce distress through a variety of techniques.

Sponsors & Collaborators

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Bonnie A. McGregor, PhD · Fred Hutchinson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01048528 on ClinicalTrials.gov