Clinical trial · Interventional
Health SMART (Stress Management and Relaxation Training)
Phase II Study of Stress Management and Vaccine Response Among Women at Risk for Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study will examine the effects of a cognitive behavioral stress management (CBSM) group intervention on antibody and cellular immune function among women who are at elevated risk for breast cancer because of family history. Hypothesis 1: Women who participate in the CBSM intervention will have a larger primary and secondary antibody response to HA vaccine compared to women in the comparison group. Hypothesis 2: In response to stimulation with HA antigen, lymphocytes from women who participate in the CBSM intervention will have larger primary and secondary in-vitro proliferative response to HA antigen, and increased primary and secondary in-vitro TH1 cytokine response to HA antigen compared to lymphocytes from women in the comparison group. Hypothesis 3: Women who participate in the 10-week CBSM group intervention will report lower levels of distress immediately after the intervention compared to women in the comparison group. Changes in distress as a result of the intervention will be associated with any significant changes in immune function discovered in Aims 1 and 2.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Behavioral Stress Management (CBSM) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stress Management
- description
- Stress Management and Relaxation Training workshops
- interventionNames
- Behavioral: Cognitive Behavioral Stress Management (CBSM)
- type
- NO_INTERVENTION
- label
- Wait-list
- description
- Wait-list comparison group
Primary outcomes (1)
- measure
- Linear mixed models regression with an exchangeable covariance structure will be used to determine the average change in IgM, IgG and proliferative response to HA vaccine antibody response to HA vaccine following the intervention, as a function of time.
- timeFrame
- From post-intervention to 1-month post-intervention (primary antibody response) and from 6-months post-intervention to 7-months post-intervention (secondary antibody response)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Family history of breast cancer * Fluent in English * Working phone and address * Plan to live in the area for one year * Reporting elevated levels of distress at screening. 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 * Use of immune modulating drugs (e.g. corticosteroids, antihistamines), nicotine, or \> 3 drinks/ day alcohol
References
Publications (1)
- DERIVEDSannes TS, Dolan E, Albano D, Ceballos RM, McGregor BA. Stress management reduces intraindividual cortisol variability, while not impacting other measures of cortisol rhythm, in a group of women at risk for breast cancer. J Psychosom Res. 2015 Nov;79(5):412-9. doi: 10.1016/j.jpsychores.2015.09.012. Epub 2015 Sep 28. PMID 26526317