Clinical trial · Interventional
Mindfulness, Breast Cancer and Psycho-Immune Dysregulation
Mindfulness Based Stress Reduction for Psycho-Immune Dysregulation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Health Education Series | Other | — | UNRESOLVED |
| Mindfulness Based Stress Reduction | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mindfulness Based Stress Reduction
- description
- 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).
- interventionNames
- Behavioral: Mindfulness Based Stress Reduction
- type
- ACTIVE_COMPARATOR
- label
- Health Education Series
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 28 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (13)
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- BACKGROUNDBuysse 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
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- BACKGROUNDCutrona CE and Russell DW. 1987. The provisions of social relationships and adaptation to stress. Advances in Personal Relationships. 1:37-6.
- BACKGROUNDFerrans 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
- BACKGROUNDJalowiec A, Murphy SP, Powers MJ. Psychometric assessment of the Jalowiec Coping Scale. Nurs Res. 1984 May-Jun;33(3):157-61. PMID 6563533
- BACKGROUNDKabat-Zinn, J. 1990. Full Catastrophe Living. Delacorte, New York.
- BACKGROUNDKirschbaum 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
- BACKGROUNDRadloff, 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