Mindfulness, Breast Cancer and Psycho-Immune Dysregulation

NCT ID: NCT03652935

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-15
• Study Completion Date: 2013-12-16

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Mindfulness Based Stress Reduction

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).

Group Type: EXPERIMENTAL

Mindfulness Based Stress Reduction

Intervention Type: BEHAVIORAL

Health Education Series

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.

Group Type: ACTIVE_COMPARATOR

Health Education Series

Intervention Type: OTHER

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

Interventions

Mindfulness Based Stress Reduction

Intervention Type: BEHAVIORAL

Health Education Series

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 28 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Loyola University

OTHER

Sponsor Role: lead

Responsible Party

Linda Janusek

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Linda Janusek, PhD

Role: PRINCIPAL_INVESTIGATOR

Loyola University Chicago

References

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.

Reference Type: BACKGROUND

PMID: 17520797 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2748771 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6668417 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 2342979 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 6563533 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 8047637 (View on PubMed)

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

Reference Type: BACKGROUND

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 14711465 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17092654 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18359186 (View on PubMed)

Other Identifiers

200101

Identifier Type: -

Identifier Source: org_study_id