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Mindfulness, Breast Cancer and Psycho-Immune Dysregulation

NCT03652935 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2018-08-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate the benefits of a Mindfulness Based Stress Reduction (MBSR) program for psycho-immune dysregulation in women newly diagnosed with breast cancer compared to women with breast cancer completing an attention control condition (health education classes). Women will be randomized to either the MBSR or health education classes. They will complete psychometric instruments evaluating psychological outcomes and will provide blood samples for immune outcomes. They will also provide saliva samples for cortisol diurnal rhythm determination. Measures will be done longitudinally pre and post MBSR or health education program. It is hypothesized that MBSR participants will exhibit improved psychological and immunological outcomes over time, as compared to women randomized to the health education classes.

Conditions

Interventions

BEHAVIORAL

Mindfulness Based Stress Reduction

OTHER

Health Education Series

This is an active comparator condition that consists of 8 weekly classes related to health.

Sponsors & Collaborators

  • Loyola University

    lead OTHER

Principal Investigators

  • Linda Janusek, PhD · Loyola University Chicago

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
28 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-15
Primary Completion
2013-12-16
Completion
2013-12-16

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03652935 on ClinicalTrials.gov