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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00121160 |
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Date of registration:
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13/07/2005 |
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Primary sponsor: |
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Public title:
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Health SMART (Stress Management and Relaxation Training) to Improve Vaccine Immune Response
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Scientific title:
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Can Stress Management Improve Vaccine Immune Response |
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Date of first enrolment:
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September 2005 |
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Target sample size:
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126 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00121160 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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United States
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Contacts
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Name:
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Bonnie A. McGregor, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fred Hutchinson Cancer Research Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Psychological Stress
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Intervention(s)
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Behavioral: Cognitive Behavioral Stress Management (CBSM) group intervention
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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IRB-6003
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NCI-K01-CA107085-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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