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Clinical Trial: Health SMART (Stress Management and Relaxation Training) to Improve Vaccine Immune Response
This study is not yet open for patient recruitment.
Purpose
| Condition | Intervention |
|---|---|
| Psychological Stress | Behavior: Cognitive Behavioral Stress Management group intervention |
MedlinePlus related topics: Stress
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Can Stress Management Improve Vaccine Immune Response
Secondary Outcomes: Multiple regression analyses will be used to test changes in cortisol and changes in perceived risk of breast cancer; coping or social support mediate the effects of the intervention on antibody response to vaccine and distress
Expected Total Enrollment: 226
Study start: September 2005; Expected completion: August 2010
Last follow-up: August 2009; Data entry closure: August 2009
Chronic stress can impair immune function, including immune response to vaccines. This has important implications for cancer control and prevention because tumor vaccines are emerging as tools for cancer treatment and prevention, and the cohort that would benefit from the vaccines is likely to be stressed. Women at elevated risk for breast cancer experience significant levels of distress that have been associated with 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, but the findings to date are mixed, in part because most intervention studies have been done with medical patients who by nature have immune confounds. Thus, it is unknown how stress management interventions affect immune function in stressed but otherwise healthy people, such as women at elevated risk for breast cancer.
Comparison: Women will be randomly assigned to a 10-week structured, CBSM intervention or a wait-list comparison group with delay participation in the intervention. The comparison group will be offered the full CBSM intervention after all assessment time points have been completed.
Eligibility
Accepts Healthy Volunteers
Inclusion Criteria:
- Female, age 18-60 years
- Family history of breast cancer
- Fluent in English
- Working phone
- Working address
- Plan to live in the area for one year
Exclusion Criteria:
Location and Contact Information
Denise L. Valley, BS 206-667-2428 dvalley@fhcrc.org
Washington
Fred Hutchinson Cancer Research Center, Seattle, Washington, 98109, United States
Eric Hutchenson 206-667-7362 ehutches@fhcrc.org
Bonnie A. McGregor, PhD, Principal Investigator
Bonnie A. McGregor, PhD, Principal Investigator, Fred Hutchinson Cancer Research Center
More Information
Publications
McEwen BS. Protective and damaging effects of stress mediators. N Engl J Med. 1998 Jan 15;338(3):171-9. Review. No abstract available.
Reichlin S. Alternative pathways of neural control of the immune process. Ann N Y Acad Sci. 1998 May 1;840:301-16. Review.
Cohen S, Miller GE, Rabin BS. Psychological stress and antibody response to immunization: a critical review of the human literature. Psychosom Med. 2001 Jan-Feb;63(1):7-18. Review.
Miller GE, Cohen S. Psychological interventions and the immune system: a meta-analytic review and critique. Health Psychol. 2001 Jan;20(1):47-63.
Cohen M, Klein E, Kuten A, Fried G, Zinder O, Pollack S. Increased emotional distress in daughters of breast cancer patients is associated with decreased natural cytotoxic activity, elevated levels of stress hormones and decreased secretion of Th1 cytokines. Int J Cancer. 2002 Jul 20;100(3):347-54.
Lerman C, Kash K, Stefanek M. Younger women at increased risk for breast cancer: perceived risk, psychological well-being, and surveillance behavior. J Natl Cancer Inst Monogr. 1994;(16):171-6.
Kash KM, Holland JC, Halper MS, Miller DG. Psychological distress and surveillance behaviors of women with a family history of breast cancer. J Natl Cancer Inst. 1992 Jan 1;84(1):24-30.
Lloyd S, Watson M, Waites B, Meyer L, Eeles R, Ebbs S, Tylee A. Familial breast cancer: a controlled study of risk perception, psychological morbidity and health beliefs in women attending for genetic counselling. Br J Cancer. 1996 Aug;74(3):482-7.
Hopwood P, Keeling F, Long A, Pool C, Evans G, Howell A. Psychological support needs for women at high genetic risk of breast cancer: some preliminary indicators. Psychooncology. 1998 Sep-Oct;7(5):402-12.
Erblich J, Bovbjerg DH, Valdimarsdottir HB. Looking forward and back: distress among women at familial risk for breast cancer. Ann Behav Med. 2000 Winter;22(1):53-9.
Decruyenaere M, Evers-Kiebooms G, Welkenhuysen M, Denayer L, Claes E. Cognitive representations of breast cancer, emotional distress and preventive health behaviour: a theoretical perspective. Psychooncology. 2000 Nov-Dec;9(6):528-36.
Record last reviewed: July 2005
Last Updated: July 25, 2005
Record first received: July 20, 2005
ClinicalTrials.gov Identifier: NCT00121160
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-26
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