Mindfulness, Breast Cancer and Psycho-Immune Dysregulation

NCT03652935 | Completed

• 1 other identifier: 200101
• Study Type: interventional
• Target: 192
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

Breast cancer, mindfulness, immune, stress

Outcome Measures

Primary Outcomes (6)

• Change in Natural Killer Cell Activity

  Natural killer cell lytic activity (NKCA) against tumor targets will be assessed ex vivo using participant peripheral blood mononuclear cells (PBMC) in a standard chromium release assay, as we described previously (Witek-Janusek, L. et al., 2007).

  Change from baseline NKCA to 36 weeks.

• Change in Cytokine Levels

  Plasma levels of cytokines, Interleukin 6 (IL-6) and Tumor Necrosis Factor (TNF) alpha and PBMC cytokine production of these cytokines and interferon (IFN) gamma will be determined. Measurement of individual cytokines will be by quantitative sandwich enzyme immunoassay (R \& D Systems, Minneapolis, MN), as we described previously (Witek-Janusek, L. et al., 2007; Witek-Janusek, et al., 2008).

  Change from baseline cytokine level to 36 weeks.

• Change in Perceived Stress

  The construct, perceived stress, will be measured using the Perceived Stress Scale (Cohen, S. et al., 1983). The Perceived Stress Scale is a 10-item instrument that assesses the degree to which life experiences are appraised as uncontrollable. Individual items are summed, with scores ranging from 0 (minimum) to 40 (maximum); higher scores indicate higher perceived stress.

  Change from baseline perceived stress level to 36 weeks.

• Change in Depression

  The construct, depression, will be measured using the Center for Epidemiologic Studies - Depression scale. This is a 20-item measure that asks individuals to rate how often over the past week they experienced symptoms associated with depression. Individual items are summed with scores ranging from 0 (minimum) to 60 (maximum); higher scores indicate greater depressive symptoms (Radloff, LS, 1977).

  Change from baseline depression level to 36 weeks.

• Change in Fatigue

  The construct, fatigue, refers to a subjective sense of tiredness. Fatigue will be measured using the Multidimensional Fatigue Symptom Inventory-Short Form, which consists of 30 items that assess the extent of fatigue experienced by the respondent. Individual items are summed with scores ranging from -24 to 96. Higher score indicates greater fatigue (Stein, KD, et al., 2004).

  Change from baseline fatigue level to 36 weeks.

• Change in Sleep

  The construct, sleep quality, will be measured using the Pittsburgh Sleep Quality Index, which consists of 19 items that measure a person's perception of their sleep quality. An overall score is calculated by summing items. Scores range from 0 (minimum) to 21 (maximum), where lower scores denote a better sleep quality (Buysse, DJ, et al., 1989).

  Change from baseline sleep quality level to 36 weeks.

Secondary Outcomes (5)

• Change in Cortisol

  Change from baseline cortisol level to 36 weeks.

• Change in Quality of Life in Cancer

  Change from baseline quality of life level to 36 weeks.

• Change in Social Support

  Change from baseline social support level to 36 weeks.

• Change in Coping

  Change from baseline to 36 weeks.

• Change in Wrist Actigraphy Measure of Sleep Quality

  Change from baseline actigraphy to 36 weeks.

Study Arms (2)

Mindfulness Based Stress Reduction

EXPERIMENTAL

The Mindfulness Based Stress Reduction (MBSR) program consists of an 8-week (2.5 hr/wk) program with a 6-hour silent mindful practice retreat after the fifth week. A licensed clinical psychologist, certified as an MBSR instructor, will provide instruction to all groups. Mindfulness will be taught using breath awareness, sitting and walking meditation, and mindful yoga. Participants will be given a standardized session-by-session program workbook containing weekly objectives and assignments, as well as two practice recordings and the book, Full Catastrophe Living (Kabat-Zinn, J, 1990).

Behavioral: Mindfulness Based Stress Reduction

Health Education Series

ACTIVE COMPARATOR

The active comparator condition consists of an 8-week educational series, administered in group-format, and matched in duration and frequency to the MBSR program. Session topics include: 1) Understanding Breast Cancer and Risks for Breast Cancer, 2) Breast Cancer Treatment, 3) Communicating Effectively with your Health Care Providers; Keeping your Medical Records, 4) Genetic Testing and Cancer, 5) Nutrition and Cancer, (6) Cooking Demonstration, 7) Bone Health, and 8) Image and Cancer (American Cancer Society - Look Good, Feel Better). The program content and objectives were reviewed by four content experts (oncology clinicians) and two breast cancer survivors.

Other: Health Education Series

Interventions

Mindfulness Based Stress Reduction BEHAVIORAL

Mindfulness Based Stress Reduction

Health Education Series OTHER

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

Health Education Series

Eligibility Criteria

• Age: 28 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women
• Early Stage Breast Cancer

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead

Related Publications (13)

• Morgenthaler T, Alessi C, Friedman L, Owens J, Kapur V, Boehlecke B, Brown T, Chesson A Jr, Coleman J, Lee-Chiong T, Pancer J, Swick TJ; Standards of Practice Committee; American Academy of Sleep Medicine. Practice parameters for the use of actigraphy in the assessment of sleep and sleep disorders: an update for 2007. Sleep. 2007 Apr;30(4):519-29. doi: 10.1093/sleep/30.4.519.

  PMID: 17520797 BACKGROUND

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Cutrona CE and Russell DW. 1987. The provisions of social relationships and adaptation to stress. Advances in Personal Relationships. 1:37-6.

  BACKGROUND

• Ferrans CE. Development of a quality of life index for patients with cancer. Oncol Nurs Forum. 1990 May-Jun;17(3 Suppl):15-9; discussion 20-1.

  PMID: 2342979 BACKGROUND

• Jalowiec A, Murphy SP, Powers MJ. Psychometric assessment of the Jalowiec Coping Scale. Nurs Res. 1984 May-Jun;33(3):157-61.

  PMID: 6563533 BACKGROUND

• Kabat-Zinn, J. 1990. Full Catastrophe Living. Delacorte, New York.

  BACKGROUND

• Kirschbaum C, Hellhammer DH. Salivary cortisol in psychoneuroendocrine research: recent developments and applications. Psychoneuroendocrinology. 1994;19(4):313-33. doi: 10.1016/0306-4530(94)90013-2.

  PMID: 8047637 BACKGROUND

• Radloff, LS 1977. The CES-D Scale: A self-report depression scale for research in the general population. Applied Psychological Measurement 1:385-401. doi.org/10.1177/014662167700100306

  BACKGROUND

• Raudenbush, SW and Bryk, AS. 2002. Hierarchical Linear Models: Applications and Data Analysis Methods, 2 ed. Sage, Thousand Oaks, CA.

  BACKGROUND

• Stein KD, Jacobsen PB, Blanchard CM, Thors C. Further validation of the multidimensional fatigue symptom inventory-short form. J Pain Symptom Manage. 2004 Jan;27(1):14-23. doi: 10.1016/j.jpainsymman.2003.06.003.

  PMID: 14711465 BACKGROUND

• Witek-Janusek L, Gabram S, Mathews HL. Psychologic stress, reduced NK cell activity, and cytokine dysregulation in women experiencing diagnostic breast biopsy. Psychoneuroendocrinology. 2007 Jan;32(1):22-35. doi: 10.1016/j.psyneuen.2006.09.011. Epub 2006 Nov 7.

  PMID: 17092654 BACKGROUND

• Witek-Janusek L, Albuquerque K, Chroniak KR, Chroniak C, Durazo-Arvizu R, Mathews HL. Effect of mindfulness based stress reduction on immune function, quality of life and coping in women newly diagnosed with early stage breast cancer. Brain Behav Immun. 2008 Aug;22(6):969-81. doi: 10.1016/j.bbi.2008.01.012. Epub 2008 Mar 21.

  PMID: 18359186 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Linda Janusek, PhD

  Loyola University Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2018
• First Posted: August 29, 2018
• Study Start: September 15, 2008
• Primary Completion: December 16, 2013
• Study Completion: December 16, 2013
• Last Updated: August 29, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share