Clinical trial NCT03652935: Mindfulness, Breast Cancer and Psycho-Immune Dysregulation
Official title: Mindfulness Based Stress Reduction for Psycho-Immune Dysregulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer, mindfulness, immune, stress
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 192
Sex: FEMALE
Minimum age (years): 28
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: The Mindfulness-Based Stress Reduction (MBSR) program is designed to cultivate conscious awareness (i.e., mindfulness) of one's experience in a non-judgmental or accepting manner (Kabat-Zinn, et al., 1990). Mindfulness programs may facilitate recovery from cancer. However, most prior mindfulness investigations for women with breast cancer focused on cancer survivors, well beyond the acute period of cancer diagnosis and treatment. Moreover, few of these studies evaluated immune measures with relevance to cancer.

Women diagnosed with early stage breast cancer (Stages 0, 1, 2, and 3) will be enrolled. Eligible women will be identified after completion of their breast surgery and when surgical pathology reports are available. Women will complete psychometric instruments and study questionnaires. They will provide blood for immune measures and saliva for cortisol diurnal rhythm. Measures will be done at five separate time points. These are pre-, mid-, and completion of either the MBSR or the attention control program, as well as at 1- and 6-months post-program. Demographic information and information about health behaviors will be collected by self-report. Wrist actigraphy for an additional assessment of sleep quality will be done in an exploratory manner. Hierarchical linear modeling will be used to compute multilevel model for change, based on full maximum likelihood estimation (Raudenbush, S. W., and A. S. Bryk. 2002). Hierarchical linear modeling will be applied to examine intra-individual and inter-individual differences in initial status (baseline) and trajectories of change over time.

Eligibility criteria: Inclusion Criteria:

* Women
* Early Stage Breast Cancer

Exclusion Criteria:

* Prior training in MBSR,
* Recurrent breast cancer,
* Metastatic breast cancer,
* Other cancers (except basal cell carcinoma),
* Immune-based disease,
* Psychoses,
* Cognitive dysfunction,
* Unable to read or write English,
* History of substance abuse,
* Use of immune-altering medications

Primary outcomes:
measure: Change in Natural Killer Cell Activity
timeFrame: Change from baseline NKCA to 36 weeks.
measure: Change in Cytokine Levels
timeFrame: Change from baseline cytokine level to 36 weeks.
measure: Change in Perceived Stress
timeFrame: Change from baseline perceived stress level to 36 weeks.
measure: Change in Depression
timeFrame: Change from baseline depression level to 36 weeks.
measure: Change in Fatigue
timeFrame: Change from baseline fatigue level to 36 weeks.
measure: Change in Sleep
timeFrame: Change from baseline sleep quality level to 36 weeks.
Secondary outcomes:
measure: Change in Cortisol
timeFrame: Change from baseline cortisol level to 36 weeks.
measure: Change in Quality of Life in Cancer
timeFrame: Change from baseline quality of life level to 36 weeks.
measure: Change in Social Support
timeFrame: Change from baseline social support level to 36 weeks.
measure: Change in Coping
timeFrame: Change from baseline to 36 weeks.
measure: Change in Wrist Actigraphy Measure of Sleep Quality
timeFrame: Change from baseline actigraphy to 36 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: Loyola University Chicago
name: Linda Janusek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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