CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 192 enrolled
Drug / intervention
Mindfulness Based Stress Reduction +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03652935
NCT03652935N/ACompleted

Mindfulness Based Stress Reduction for Psycho-Immune Dysregulation

Loyola University·interventional·Posted Aug 29, 2018·Updated Aug 29, 2018

In Brief

A clinical study evaluating Mindfulness Based Stress Reduction and Health Education Series for Breast Cancer. Completed, enrolled 192 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
Countries--
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 29, 2018
Enrollment StartSep 15, 2008
Primary CompletionDec 16, 2013
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 7.8 years ago

Interventions

Mindfulness Based Stress Reductionbehavioral

Health Education Seriesother

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