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

Stress Clinical Trial

— VSMART  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03955991
• Other study ID #: 20160525
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 21, 2016
• Est. completion date: July 1, 2024

Study information

• Verified date: August 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Must meet the criterion of a score of >14 on the Impact of Event Scale-Intrusion scale (IES-I48) for cancer-specific distress or self-report at least moderate distress (score of 4 or greater) on a screening question, "How would you rate your distress level, over the past week, on a scale of 0 to 10, with 0 meaning no distress and 10 being extreme distress"

2. No prior history of cancer (with the exception of non-melanoma skin cancer)

3. Life expectancy of > 12 months.

4. No diagnosis of major psychiatric condition or mental disorder (i.e. schizophrenia, psychosis, and/or bipolar disorder) or active (in the past 12 months) Major Depressive Disorder (MDD), panic disorder, Post Traumatic Stress Disorder (PTSD) diagnosis or history of suicide thoughts, attempts or plans.

5. No substance dependency in the past 12 months.

6. No acute or chronic co-morbid medical condition with known effects on the immune system (e.g., HIV infection, autoimmune diseases)

7. No prior neo-adjuvant therapy

8. No current medications that act as direct immunomodulators (e.g., Granulocyte Macrophage Colony Stimulating Factor (GM-CSF), interferons)

9. No significant cognitive impairment, must score <31 on the Telephone Interview for Cognitive Status (TICS)49.

10. At least a 6th grade reading level in English and be available for follow-up

11. Women age 50 and older diagnosed with stage 0-III breast cancer.

Exclusion Criteria:

• Does not meet all Inclusion Criteria.

Related Conditions & MeSH terms

• Breast Neoplasms
• Stress

Intervention

Behavioral:
• R-CBSM
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.

Biological:
• Influenza vaccine
Standard of care Influenza vaccine for that given year.

Locations

Country	Name	City	State
United States	Flipse Building	Coral Gables	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Florida Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemagglutination inhibition assay (HAI) - Fold response to IV	As measure HAI antibody titers change from pre-vaccine to 28 days post vaccine	28 days post vaccine
Primary	Percent of cases that achieve a clinical vaccine response of greater than or equal to 4 fold titer increase.	Participant's score will be dichotomized into whether 4 fold increase was achieved. Via serum.	28 days post vaccine
Secondary	Change in Affective Status	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	Baseline (T0), 6 months (T1), 7-days post IV (T2), 28-day post IV (T3), 12 month post Baseline (T4).
Secondary	Change in Circulating Cytokine levels	Serum from blood samples will be evaluated for cytokine indices for Interleukin; (IL) 1, IL-6 and Tumor Necrosis Factor (TNF-Alpha).	Baseline (T0), 6 months (T1), 7-days post IV (T2), 28-day post IV (T3)
Secondary	Change in Affective Status markers	Affective status change as measured by a Latent variable that compares the effects of the 2 groups.	Baseline (T0) to 28-day post IV (T3).
Secondary	Change in Immune Status measured by Activation Induced Cytidine Deaminase (AID) in response to Cytosine-phosphate -Guanine (CpG)	Level of AID activity in B cells	Baseline (T0) to 6 months (T1).
Secondary	Change in Immune Status measured by Switched B-cells (swB)	Percentage of B-cells indicator.	Baseline (T0) to 28-day post IV (T3).
Secondary	Magnitude of Immune changes associated with Flu Vaccine response	Measured by a change score in sw B-Cell and AID response with change HAI response	Baseline (T0) to 28-day post IV (T3)
Secondary	Magnitude of Inflammatory changes associated with Flu Vaccine response	Measured by a change score in inflammatory cytokines with change in HAI response	Baseline (T0) to 28-day post IV (T3)