Health SMART (Stress Management and Relaxation Training)

Study Overview
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Brief Summary
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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.

Detailed Description
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Cancer vaccines are emerging as important tools for cancer treatment and prevention. Unfortunately, the cohorts that ultimately will benefit most from the vaccines, those at elevated risk for cancer, are likely to be stressed. Chronic stress can impair immune function, including immune response to vaccines. An inadequate response to vaccines can weaken their protective effect. Women at elevated risk for breast cancer can experience significant levels of distress and have associated immune function decrements. Interventions to treat distress-related immune decrements among these women are needed because these women will be among the first candidates for breast cancer vaccines. In theory, stress-management interventions should improve immune function and response to vaccines; however, the findings to date are mixed. The proposed investigation will conduct an exploratory randomized clinical trial to collect preliminary data on the efficacy of a cognitive behavioral stress management (CBSM) group intervention among women who are at elevated risk for breast cancer because of family history and who are reporting elevated levels of distress. Study outcomes will include antibody and cellular immune response to hepatitis A vaccine and self-reported distress.

Official Title
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Phase II Study of Stress Management and Vaccine Response Among Women at Risk for Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Stress Management (CBSM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stress Management<br>Stress Management and Relaxation Training workshops | Behavioral: Cognitive Behavioral Stress Management (CBSM)<br>* 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.<br>* Other names: Stress Management and Relaxation Training (SMART);|
| No Intervention: Wait-list<br>Wait-list comparison group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immune response to vaccines, stress management, perceived risk for breast cancer