Mindfulness-Based Stress Reduction (MBSR) Symptom Cluster Trial for Breast Cancer Survivors

NCT01177124 | Completed DMC

• 1 other identifier: 1R01CA131080-01A2
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

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

Breast Cancer

Keywords

Breast cancer; Survivors; Mindfulness-Based Stress Reduction (MBSR); Symptoms; Immune markers

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline, 6 weeks and 12 weeks

Secondary Outcomes (1)

• To test whether positive effects achieved from the MBSR(BC) program are mediated through changes in mindfulness and fear of recurrence of breast cancer

  Baseline, 6 weeks and 12 weeks

Study Arms (2)

MBSR 6 Weeks Program

EXPERIMENTAL

Behavioral: MBSR 6 Weeks Program

Usual Care (UC)

NO INTERVENTION

Interventions

MBSR 6 Weeks Program BEHAVIORAL

MBSR is a clinical program that provides systematic training to promote stress reduction by self-regulating arousal to stress. The goal of training is to teach participants to become more aware of their thoughts and feelings, and through meditation practice, to have the ability to step back from thoughts and feelings during stressful situations that contribute to increased emotional distress. The intervention incorporates simple yoga, sitting meditation, body scan, and walking meditation in a 6-week program (Kabat-Zinn et al. 1985; Teasdale et al. 1995).

Also known as: MBSR

MBSR 6 Weeks Program

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Advanced stage (IV) cancer
• Current psychiatric diagnosis
• Recurrent treatment for prior breast cancer

Sponsors & Collaborators

• Cecile Lengacher: lead

Study Sites (3)

Carol and Frank Morsani Center for Advanced Healthcare

Tampa, Florida, 33617, United States

Location

Moffitt Cancer Center and Research Institute

Tampa, Florida, 33617, United States

Location

University of South Florida

Tampa, Florida, 33617, United States

Location

Related Publications (22)

• Kenefick 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 BACKGROUND

• Byar 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 BACKGROUND

• Dodd 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 BACKGROUND

• Esper 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 BACKGROUND

• Barsevick 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 BACKGROUND

• Lee 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 BACKGROUND

• Cleeland 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 BACKGROUND

• Cimprich 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.

  PMID: 15651055 BACKGROUND

• Mishel MH, Germino BB, Gil KM, Belyea M, Laney IC, Stewart J, Porter L, Clayton M. Benefits from an uncertainty management intervention for African-American and Caucasian older long-term breast cancer survivors. Psychooncology. 2005 Nov;14(11):962-78. doi: 10.1002/pon.909.

  PMID: 15712339 BACKGROUND

• Stanton AL, Ganz PA, Kwan L, Meyerowitz BE, Bower JE, Krupnick JL, Rowland JH, Leedham B, Belin TR. Outcomes from the Moving Beyond Cancer psychoeducational, randomized, controlled trial with breast cancer patients. J Clin Oncol. 2005 Sep 1;23(25):6009-18. doi: 10.1200/JCO.2005.09.101.

  PMID: 16135469 BACKGROUND

• Scheier MF, Helgeson VS, Schulz R, Colvin S, Berga S, Bridges MW, Knapp J, Gerszten K, Pappert WS. Interventions to enhance physical and psychological functioning among younger women who are ending nonhormonal adjuvant treatment for early-stage breast cancer. J Clin Oncol. 2005 Jul 1;23(19):4298-311. doi: 10.1200/JCO.2005.05.362.

  PMID: 15994143 BACKGROUND

• Kabat-Zinn J, Massion AO, Kristeller J, Peterson LG, Fletcher KE, Pbert L, Lenderking WR, Santorelli SF. Effectiveness of a meditation-based stress reduction program in the treatment of anxiety disorders. Am J Psychiatry. 1992 Jul;149(7):936-43. doi: 10.1176/ajp.149.7.936.

  PMID: 1609875 BACKGROUND

• Miller JJ, Fletcher K, Kabat-Zinn J. Three-year follow-up and clinical implications of a mindfulness meditation-based stress reduction intervention in the treatment of anxiety disorders. Gen Hosp Psychiatry. 1995 May;17(3):192-200. doi: 10.1016/0163-8343(95)00025-m.

  PMID: 7649463 BACKGROUND

• Teasdale JD, Segal ZV, Williams JM, Ridgeway VA, Soulsby JM, Lau MA. Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. J Consult Clin Psychol. 2000 Aug;68(4):615-23. doi: 10.1037//0022-006x.68.4.615.

  PMID: 10965637 BACKGROUND

• Kabat-Zinn J, Lipworth L, Burney R. The clinical use of mindfulness meditation for the self-regulation of chronic pain. J Behav Med. 1985 Jun;8(2):163-90. doi: 10.1007/BF00845519.

  PMID: 3897551 BACKGROUND

• Lengacher CA, Johnson-Mallard V, Post-White J, Moscoso MS, Jacobsen PB, Klein TW, Widen RH, Fitzgerald SG, Shelton MM, Barta M, Goodman M, Cox CE, Kip KE. Randomized controlled trial of mindfulness-based stress reduction (MBSR) for survivors of breast cancer. Psychooncology. 2009 Dec;18(12):1261-72. doi: 10.1002/pon.1529.

  PMID: 19235193 BACKGROUND

• Lengacher C, Gaurkee D, Mierzejewski A, et al. Feasibility of MBSR in early stage breast cancer recovery, a pilot study. Breast Cancer Research and Treatment. 2006;100(1):s289-290.

  BACKGROUND

• Teasdale JD, Segal Z, Williams JM. How does cognitive therapy prevent depressive relapse and why should attentional control (mindfulness) training help? Behav Res Ther. 1995 Jan;33(1):25-39. doi: 10.1016/0005-7967(94)e0011-7.

  PMID: 7872934 BACKGROUND

• Lengacher CA, Gruss LF, Kip KE, Reich RR, Chauca KG, Moscoso MS, Joshi A, Tinsley S, Shani B, Cousin L, Khan CP, Goodman M, Park JY. Mindfulness-based stress reduction for breast cancer survivors (MBSR(BC)): evaluating mediators of psychological and physical outcomes in a large randomized controlled trial. J Behav Med. 2021 Oct;44(5):591-604. doi: 10.1007/s10865-021-00214-0. Epub 2021 May 7.

  PMID: 33963420 DERIVED

• Reich RR, Lengacher CA, Alinat CB, Kip KE, Paterson C, Ramesar S, Han HS, Ismail-Khan R, Johnson-Mallard V, Moscoso M, Budhrani-Shani P, Shivers S, Cox CE, Goodman M, Park J. Mindfulness-Based Stress Reduction in Post-treatment Breast Cancer Patients: Immediate and Sustained Effects Across Multiple Symptom Clusters. J Pain Symptom Manage. 2017 Jan;53(1):85-95. doi: 10.1016/j.jpainsymman.2016.08.005. Epub 2016 Oct 5.

  PMID: 27720794 DERIVED

• Lengacher CA, Reich RR, Paterson CL, Ramesar S, Park JY, Alinat C, Johnson-Mallard V, Moscoso M, Budhrani-Shani P, Miladinovic B, Jacobsen PB, Cox CE, Goodman M, Kip KE. Examination of Broad Symptom Improvement Resulting From Mindfulness-Based Stress Reduction in Breast Cancer Survivors: A Randomized Controlled Trial. J Clin Oncol. 2016 Aug 20;34(24):2827-34. doi: 10.1200/JCO.2015.65.7874. Epub 2016 May 31.

  PMID: 27247219 DERIVED

• Lengacher CA, Reich RR, Paterson CL, Jim HS, Ramesar S, Alinat CB, Budhrani PH, Farias JR, Shelton MM, Moscoso MS, Park JY, Kip KE. The effects of mindfulness-based stress reduction on objective and subjective sleep parameters in women with breast cancer: a randomized controlled trial. Psychooncology. 2015 Apr;24(4):424-32. doi: 10.1002/pon.3603. Epub 2014 Jun 18.

  PMID: 24943918 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Cecile A Lengacher, RN, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 6, 2010
• Study Start: February 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 27, 2014

Record last verified: 2014-02

Locations

US (3)