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Vaccines

10 weeks of group intervention convene by a broadband connection for approximately 75-90 minutes. Intervention given prior to Influenza Vaccine.

Persons assigned to this group will receive R-CBSM approximately 28 days after receiving the Influenza Vaccine.

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.

R-CBSM

Standard of care Influenza vaccine for that given year.

Influenza vaccine

Michael H Antoni, Ph.D

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.

VSMART (Video-Conference Stress Management and Relaxation Training for Older Women With Breast Cancer)

Stress Management Effects on Affective Status and Influenza Vaccine Response in Older Breast Cancer Patients

As measure HAI antibody titers change from pre-vaccine to 28 days post vaccine

Participant's score will be dichotomized into whether 4 fold increase was achieved. Via serum.

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

Serum from blood samples will be evaluated for cytokine indices for Interleukin

(IL) 1, IL-6 and Tumor Necrosis Factor (TNF-Alpha).

Affective status change as measured by a Latent variable that compares the effects of the 2 groups.

Measured by a change score in sw B-Cell and AID response with change HAI response

Measured by a change score in inflammatory cytokines with change in HAI response

Florida Department of Health

University of Miami

Professor

Successive cohorts of participants (3 participants per tumor type per cohort) will each be started on a fixed dose of the influenza vaccine. For the first cohort, patients will receive Fluzone Quadrivalent - (Sanofi Pasteur) - 60mcg/0.5mL (standard dose IT flu shot, or dose level 0) intratumorally on day -6 +/- 1 day and day 0 or 1. For the second cohort, patients will receive Fluzone High-Dose Quadrivalent - (Sanofi Pasteur) - 240mcg/0.7mL (high dose IT flu shot, or dose level 1) intratumorally on day -6 +/- 1 day and day 0 or 1. has context menu

Fluzone Quadrivalent

Angela Limburg, RN, BSN

Angela Limburg

Ruta Rao, MD

This Phase 1 study will assess the safety and efficacy (usefulness) of administering 2 doses of seasonal flu vaccine directly into breast cancer tissue (primary tumor), and will study the tumor and whole body response to the vaccine. If the tumor is palpable (able to fee by touch), the vaccine will be administered by a Surgeon/oncologist in the outpatient floor - both experienced and trained. If not palpable, the procedure will be done via guided Ultrasound by our Breast Radiologist -- both experienced and trained. Women with triple-negative (TNBC) and HER2+ types of breast cancer will be eligible for enrollment. Up to 18 subjects may be enrolled at Rush. Successive groups of 3 subjects per breast cancer type will be given increasing doses of vaccine. There are 3 potential dosing groups (half-dose, full dose, and high dose). Blood, stool (optional), and tumor tissue samples will be collected and tested. The active participation period is from one week prior to starting chemotherapy through three months post surgery.

A Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer

A Phase I Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer

The primary objective of this trial is to assess the safety of intratumoral (IT) influenza vaccine administration in patients with breast cancer receiving neoadjuvant chemotherapy, by evaluating the percentage of patients experiencing dose- limiting toxicity (DLT).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
VSMART (Video-Conference Stress Management and Relaxation Training for Older Women With Breast Cancer)	NCT03955991	Stress	R-CBSM Influenza vacci...	50 Years -	University of Miami
VSMART (Video-Conference Stress Management and Relaxation Training for Older Women With Breast Cancer)	NCT03955991	Stress	R-CBSM Influenza vacci...	50 Years -	University of Miami
A Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer	NCT06229392	Breast Cancer Breast Cancer T...	Fluzone Quadriv...	18 Years -	Rush University Medical Center
A Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer	NCT06229392	Breast Cancer Breast Cancer T...	Fluzone Quadriv...	18 Years -	Rush University Medical Center

Spots Global Cancer Trial Database for flu vaccine

Every month we try and update this database with for flu vaccine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for flu vaccine

Every month we try and update this database with for flu vaccine cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for flu vaccine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.