NCT00584142

Brief Summary

The purpose of this study was two-fold: (i) to assess whether MBSR favorably influences psychological status, quality of life, stress hormones, and immune status in breast cancer survivors; and (ii) to explore possible mechanisms by which MBSR may favorably influence these outcomes, in particular, through reduction in fear of breast cancer recurrence and associated perceived stress. Both objectives were studied at the critical transition time immediately following completion of surgical, radiation and/or chemotherapy therapy for breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 2, 2008

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 18, 2012

Status Verified

December 1, 2007

Enrollment Period

5.9 years

First QC Date

December 21, 2007

Last Update Submit

June 14, 2012

Conditions

Breast Cancer

Keywords

breast cancersurvivors

Outcome Measures

Primary Outcomes (1)

  • To assess whether MBSR favorably influences psychological status (anxiety, perceived stress, depression), quality of life, and immune status (among post-treatment breast cancer survivors)

    6 weeks

Secondary Outcomes (1)

  • To explore possible mechanisms by which MBSR may favorably influence psychological status, quality of life, and/or immune status (in other words, "how" MBSR may work) (among post-treatment breast cancer survivors)

    6 weeks

Study Arms (2)

1

EXPERIMENTAL
Behavioral: Mindfulness-Based Stress Reduction

2

NO INTERVENTION

Interventions

Mindfulness-Based Stress ReductionBEHAVIORAL

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.

Also known as: MBSR
1

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old or older
  • Diagnosed with Stage 0, I, II, or III breast cancer
  • Undergone lumpectomy and completed adjuvant radiation and/or chemotherapy (end of treatment to 18 months post-treatment)
  • Ability to read and speak English at the 8th grade level to respond to the survey questions

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

Location

Related Publications (1)

  • 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: 19235193DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

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

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 2, 2008

Study Start

March 1, 2006

Primary Completion

February 1, 2012

Study Completion

June 1, 2012

Last Updated

June 18, 2012

Record last verified: 2007-12

Locations

US(1)