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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-21

Study Completion Date

2024-06-01

Brief Summary

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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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Detailed Description

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Conditions

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Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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R-CBSM

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

Group Type EXPERIMENTAL

R-CBSM

Intervention Type BEHAVIORAL

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.

Influenza vaccine

Intervention Type BIOLOGICAL

Standard of care Influenza vaccine for that given year.

Wait List Condition (WLC)

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

Group Type ACTIVE_COMPARATOR

R-CBSM

Intervention Type BEHAVIORAL

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.

Influenza vaccine

Intervention Type BIOLOGICAL

Standard of care Influenza vaccine for that given year.

Interventions

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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.

Intervention Type BEHAVIORAL

Influenza vaccine

Standard of care Influenza vaccine for that given year.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No