Clinical trial · Interventional
Mindfulness-Based Stress Reduction (MBSR) Symptom Cluster Trial for Breast Cancer Survivors
NCT01177124CI-TRIAL-00013892completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 among breast cancer survivors is three-fold: (i) to evaluate the efficacy of the MBSR(BC) program in improving psychological and physical symptoms, quality of life and measures of immune function and a stress hormone (cortisol); (ii) to test whether positive effects achieved from the MBSR(BC) program are mediated through changes in mindfulness and fear of recurrence of breast cancer; and (iii) to evaluate whether positive effects achieved from the MBSR(BC) program are modified by specific patient characteristics measured at baseline.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MBSR 6 Weeks Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MBSR 6 Weeks Program
- interventionNames
- Behavioral: MBSR 6 Weeks Program
- type
- NO_INTERVENTION
- label
- Usual Care (UC)
Primary outcomes (1)
- measure
- To evaluate the efficacy of the MBSR(BC) program in improving psychological and physical symptoms, quality of life and measures of immune function and a stress hormone (cortisol)
- timeFrame
- Baseline, 6 weeks and 12 weeks
Secondary outcomes (1)
- measure
- To test whether positive effects achieved from the MBSR(BC) program are mediated through changes in mindfulness and fear of recurrence of breast cancer
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * 21 years or older * Diagnosed with Stage 0, I, II, or III breast cancer * Undergone lumpectomy and/or mastectomy and are at 2 weeks from end of treatment with adjuvant radiation and/or chemotherapy or are a maximum of 2 years out from completion of such treatment * Ability to read and speak English at the 8th grade level or above to respond to survey questions Exclusion Criteria: * Advanced stage (IV) cancer * Current psychiatric diagnosis * Recurrent treatment for prior breast cancer
References
Publications (22)
- BACKGROUNDKenefick AL. Patterns of symptom distress in older women after surgical treatment for breast cancer. Oncol Nurs Forum. 2006 Nov 3;33(2):327-35. doi: 10.1188/06.ONF.327-335. PMID 16518448
- BACKGROUNDByar KL, Berger AM, Bakken SL, Cetak MA. Impact of adjuvant breast cancer chemotherapy on fatigue, other symptoms, and quality of life. Oncol Nurs Forum. 2006 Jan 1;33(1):E18-26. doi: 10.1188/06.ONF.E18-E26. PMID 16470230
- BACKGROUNDDodd MJ, Miaskowski C, Paul SM. Symptom clusters and their effect on the functional status of patients with cancer. Oncol Nurs Forum. 2001 Apr;28(3):465-70. PMID 11338755
- BACKGROUNDEsper P, Heidrich D. Symptom clusters in advanced illness. Semin Oncol Nurs. 2005 Feb;21(1):20-8. doi: 10.1053/j.soncn.2004.10.004. PMID 15807053
- BACKGROUNDBarsevick AM. The elusive concept of the symptom cluster. Oncol Nurs Forum. 2007 Sep;34(5):971-80. doi: 10.1188/07.ONF.971-980. PMID 17878126
- BACKGROUNDLee BN, Dantzer R, Langley KE, Bennett GJ, Dougherty PM, Dunn AJ, Meyers CA, Miller AH, Payne R, Reuben JM, Wang XS, Cleeland CS. A cytokine-based neuroimmunologic mechanism of cancer-related symptoms. Neuroimmunomodulation. 2004;11(5):279-92. doi: 10.1159/000079408. PMID 15316238
- BACKGROUNDCleeland CS, Bennett GJ, Dantzer R, Dougherty PM, Dunn AJ, Meyers CA, Miller AH, Payne R, Reuben JM, Wang XS, Lee BN. Are the symptoms of cancer and cancer treatment due to a shared biologic mechanism? A cytokine-immunologic model of cancer symptoms. Cancer. 2003 Jun 1;97(11):2919-25. doi: 10.1002/cncr.11382. PMID 12767108
- BACKGROUNDCimprich B, Janz NK, Northouse L, Wren PA, Given B, Given CW. Taking CHARGE: A self-management program for women following breast cancer treatment. Psychooncology. 2005 Sep;14(9):704-17. doi: 10.1002/pon.891.