Skip to main content
OpenTrials
Completed

NCT Number: NCT01048528

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 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Stress Management (CBSM)

Behavioral

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.

Other names: Stress Management and Relaxation Training (SMART)

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.

    Time frame: 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.

    Time frame: Length of the protocol (Basline to 7 months post-intervention)

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 13, 2010
Registry last updated
Mar 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.