Health SMART (Stress Management and Relaxation Training)
Phase II Study of Stress Management and Vaccine Response Among Women at Risk for Breast Cancer
2 other identifiers
interventional
33
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Started Jul 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 3, 2009
CompletedFirst Posted
Study publicly available on registry
January 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedMarch 27, 2012
March 1, 2012
2.6 years
November 3, 2009
March 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Linear mixed models regression with an exchangeable covariance structure will be used to determine the average change in IgM, IgG and proliferative response to HA vaccine antibody response to HA vaccine following the intervention, as a function of time.
From post-intervention to 1-month post-intervention (primary antibody response) and from 6-months post-intervention to 7-months post-intervention (secondary antibody response)
Secondary Outcomes (1)
Linear mixed model regression with an exchangeable covariance structure will be used to investigate the effects of change in distress on immune response as a function of time. We will include time as a random effect.
Length of the protocol (Basline to 7 months post-intervention)
Study Arms (2)
Stress Management
EXPERIMENTALStress Management and Relaxation Training workshops
Wait-list
NO INTERVENTIONWait-list comparison group
Interventions
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.
Eligibility Criteria
You may qualify if:
- Family history of breast cancer
- Fluent in English
- Working phone and address
- Plan to live in the area for one year
- Reporting elevated levels of distress at screening.
You may not qualify if:
- Prior cancer diagnosis (except non-melanoma skin cancer)
- Current major depressive episode
- History of Bipolar Disorder or Schizophrenia
- History of autoimmune disease
- History of Hepatitis A or HA vaccination
- Use of immune modulating drugs (e.g. corticosteroids, antihistamines), nicotine, or \> 3 drinks/ day alcohol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Related Publications (1)
Sannes TS, Dolan E, Albano D, Ceballos RM, McGregor BA. Stress management reduces intraindividual cortisol variability, while not impacting other measures of cortisol rhythm, in a group of women at risk for breast cancer. J Psychosom Res. 2015 Nov;79(5):412-9. doi: 10.1016/j.jpsychores.2015.09.012. Epub 2015 Sep 28.
PMID: 26526317DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bonnie A. McGregor, PhD
Fred Hutchinson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 3, 2009
First Posted
January 13, 2010
Study Start
July 1, 2009
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
March 27, 2012
Record last verified: 2012-03