Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121160
Status:
COMPLETED
Last Update Posted:
2012-03-27
First Post:
2005-07-13
Brief Title:
Health SMART Stress Management and Relaxation Training to Improve Vaccine Immune Response
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Can Stress Management Improve Vaccine Immune Response
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-K01-CA107085-01 | None | None | None |