Health SMART (Stress Management and Relaxation Training) to Improve Vaccine Immune Response
NCT ID: NCT00121160
Last Updated: 2012-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
126 participants
INTERVENTIONAL
2005-09-30
2010-07-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Interventions
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Cognitive Behavioral Stress Management (CBSM) group intervention
Participants will meet in closed, structured groups of 4 to 6 women for ten weekly, 2-hour group sessions. 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. Group members and group leaders are used as role models for effective coping and the use of social support. The groups also encourage emotional expression and provide an opportunity to practice techniques learned in the group and experience 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. Each week participants also experience a different relaxation technique. The goal of the CBSM intervention is thus to reduce distress through a variety of techniques.
Eligibility Criteria
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Inclusion Criteria
* Family history of breast cancer
* Fluent in English
* Working phone
* Working address
* Plan to live in the area for one year
Exclusion Criteria
* 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
18 Years
60 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Fred Hutchinson Cancer Research Center
Principal Investigators
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Bonnie A. McGregor, PhD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Center
Locations
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Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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NCI-K01-CA107085-01
Identifier Type: -
Identifier Source: secondary_id
IRB-6003
Identifier Type: -
Identifier Source: org_study_id
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