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

University of Miami

Status and phase: Completed; Phase 4

Conditions: Stress

Treatments: Behavioral: R-CBSM; Biological: Influenza vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT03955991

20160525

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

R-CBSM

Experimental group

Description:

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

Treatment:

Biological: Influenza vaccine

Behavioral: R-CBSM

Wait List Condition (WLC)

Active Comparator group

Description:

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

Treatment:

Biological: Influenza vaccine

Behavioral: R-CBSM