- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00121160
Health SMART (Stress Management and Relaxation Training) to Improve Vaccine Immune Response
Can Stress Management Improve Vaccine Immune Response
The proposed investigation will conduct a randomized, clinical trial to test the efficacy of a cognitive behavioral stress management (CBSM) group intervention on immune response to vaccine and distress among women at elevated risk for breast cancer.
Hypothesis 1: Women who participate in the CBSM intervention will have a larger primary and secondary antibody response to vaccines compared to women in the comparison group.
Hypothesis 2: Women who participate in a 10-week CBSM group intervention will report lower levels of distress immediately after and 6 months after the intervention compared to women in the comparison group.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Washington
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Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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
- Current infectious disease
- Use of immune modulating drugs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Independent sample t-test will be used to compare 1) antibody change scores from before to after the first and second dose of vaccine, and 2) distress change scores from before to after the intervention
Time Frame: length of protocol
|
length of protocol
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Multiple regression analyzes 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
Time Frame: length of protocol
|
length of protocol
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bonnie A. McGregor, PhD, Fred Hutchinson Cancer Center
Publications and helpful links
General Publications
- McEwen BS. Protective and damaging effects of stress mediators. N Engl J Med. 1998 Jan 15;338(3):171-9. doi: 10.1056/NEJM199801153380307. No abstract available.
- Miller GE, Cohen S. Psychological interventions and the immune system: a meta-analytic review and critique. Health Psychol. 2001 Jan;20(1):47-63. doi: 10.1037//0278-6133.20.1.47.
- Reichlin S. Alternative pathways of neural control of the immune process. Ann N Y Acad Sci. 1998 May 1;840:301-16. doi: 10.1111/j.1749-6632.1998.tb09570.x.
- 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. doi: 10.1097/00006842-200101000-00002.
- 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. doi: 10.1002/ijc.10488.
- 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. doi: 10.1093/jnci/84.1.24.
- 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. doi: 10.1038/bjc.1996.387.
- 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. doi: 10.1002/(SICI)1099-1611(1998090)7:53.0.CO;2-X.
- 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. doi: 10.1007/BF02895167.
- 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. doi: 10.1002/1099-1611(200011/12)9:63.0.co;2-#.
- McGregor BA, Dolan ED, Murphy KM, Sannes TS, Highland KB, Albano DL, Ward AA, Charbonneau AM, Redman MW, Ceballos RM. Cognitive Behavioral Stress Management for Healthy Women at Risk for Breast Cancer: a Novel Application of a Proven Intervention. Ann Behav Med. 2015 Dec;49(6):873-84. doi: 10.1007/s12160-015-9726-z.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-6003
- NCI-K01-CA107085-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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