Flipse Building
Coral Gables, Florida, 33124, United States
NCT Number: NCT03955991
The proposed study tests the effects of a novel remotely-delivered group cognitive behavioral stress management (R-CBSM) intervention on improving health and quality of life in older women undergoing breast cancer (BCa) treatment. This study tests if delivered home-based group CBSM (R-CBSM) improves response to influenza vaccine (IV) in parallel with improved psychological adaptation, inflammation and other immune functioning indicators in older women treated for BCa.
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Notify Me50 year and older
Female
Interventional
Phase 4
Coral Gables, Florida, 33124, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
10 weekly educational modules via an electronic tablet. A participant workbook is also provided that contains a summary of the rationale for each module, outline of each technique, and homework exercises.
Standard of care Influenza vaccine for that given year.
Time frame: 28 days post vaccine
As measure HAI antibody titers change from pre-vaccine to 28 days post vaccine
Time frame: 28 days post vaccine
Participant's score will be dichotomized into whether 4 fold increase was achieved. Via serum.
Time frame: Baseline (T0), 6 months (T1), 7-days post IV (T2), 28-day post IV (T3), 12 month post Baseline (T4).
Affective Status is comprised of the Impact of Event Score Intrusion (IES-I), Affect Balance Scale (ABS) negative affect, positive affect and Center for Epidemiologic Studies Depression (CES-D) that comprise a latent construct
Time frame: Baseline (T0), 6 months (T1), 7-days post IV (T2), 28-day post IV (T3)
Serum from blood samples will be evaluated for cytokine indices for Interleukin
(IL) 1, IL-6 and Tumor Necrosis Factor (TNF-Alpha).
Time frame: Baseline (T0) to 28-day post IV (T3).
Affective status change as measured by a Latent variable that compares the effects of the 2 groups.
Time frame: Baseline (T0) to 6 months (T1).
Level of AID activity in B cells
Time frame: Baseline (T0) to 28-day post IV (T3).
Percentage of B-cells indicator.
Time frame: Baseline (T0) to 28-day post IV (T3)
Measured by a change score in sw B-Cell and AID response with change HAI response
Time frame: Baseline (T0) to 28-day post IV (T3)
Measured by a change score in inflammatory cytokines with change in HAI response
University of Miami
Other
Stress Management Effects on Affective Status and Influenza Vaccine Response in Older Breast Cancer Patients
Acronym: VSMART
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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