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Mindful Movement for Breast Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02619292
Recruitment Status : Completed
First Posted : December 2, 2015
Last Update Posted : July 14, 2017
Sponsor:
Information provided by (Responsible Party):
John Wayne Cancer Institute

Tracking Information
First Submitted Date  ICMJE November 6, 2015
First Posted Date  ICMJE December 2, 2015
Last Update Posted Date July 14, 2017
Actual Study Start Date  ICMJE November 2015
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2015)
Immune markers [ Time Frame: 18 weeks ]
Improvement in serum markers of immune cell phenotype at week 18
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02619292 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2015)
  • Mindful Movement Intervention Experience [ Time Frame: 18 weeks ]
    Improvement in mindfulness attitude as measured on Meditative Movement Inventory (MMI)
  • Mindful Movement Intervention Experience [ Time Frame: 18 weeks ]
    Improvement in mindfulness attitude as measured on Perceived Exertion Scale (PES)
  • Mindful Movement Intervention Experience - Mindfulness Intention [ Time Frame: 18 weeks ]
    Improvement in mindfulness attitude as measured on Mindfulness Intention (modified from Segal, 1-item)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 30, 2015)
  • Fear of Recurrence [ Time Frame: 18 weeks ]
    Fear of recurrence as measured on Fear of Recurrence (FOR) scale
  • Mindfulness attention [ Time Frame: 18 weeks ]
    Improvement in mindfulness attitude as measured with the Mindful Attention Awareness Scale (MAAS)
  • Mindfulness attitude [ Time Frame: 18 weeks ]
    Improvement in mindfulness attitude as measured with the Experiences Questionnaire (EQ)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Mindful Movement for Breast Cancer Survivors
Official Title  ICMJE Mindful Movement for Breast Cancer Survivors
Brief Summary The purpose of this study is to determine if participating in a Mindful Movement Program (MMP) (learning how to be mindful in one's movement), positively affects the body's immune functions improves mindfulness and reduces worries about cancer returning. All participants will be in this study about three months.
Detailed Description Breast cancer survivors (BCS) may experience psychological and physical effects long after treatment is over. Some research shows that practicing mindfulness, and movement types of activities such as qi gong or yoga may lead to improvements in emotional and physical well-being, including improved immune function. Immune function can be negatively affected by stress and worry, and this has an unknown effect on the risk of cancer recurrence. Psychological and physical interventions that help enhance an individual's wellbeing and reduce stress and worry may have a positive influence on immune function and in turn, reduce the risk of cancer recurrence. While there is limited research in this area, and none with dance therapy, little attention has been given to older BCS. However, understanding of immune function suggests that older women may be the best group to target for such interventions. Previous research with BCS age 50 or older who participated in a 12-week program combining mindfulness practice with dance/movement therapy (Mindful Movement Program) demonstrated positive effects: participants were more mindful in their day-to-day living and had less worry about the cancer coming back. Participants also reported through focus groups that the Mindful Movement Program (MMP) had improved their overall well-being. No laboratory tests of the body's immune response to MMP were included.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Behavioral: Mindful Movement Program
Mindfulness is turning one's awareness to the present moment. Movement-dance therapy is the expression of thoughts or feelings through body movement, under the supervision of a licensed professional.
Study Arms  ICMJE Experimental: Mindful Movement Program
Mindfulness is "moment-to-moment, present-centered, purposive non-judgmental awareness"; Dance/movement therapy is a multidimensional approach that integrates body awareness, expression and acceptance to facilitate physical, emotional, cognitive, social and spiritual integration of individuals
Intervention: Behavioral: Mindful Movement Program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 30, 2015)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • diagnosed at age 50 or older with stage 0-III disease
  • 6 months or more since completion of primary breast cancer treatment
  • have a medical release from their physician
  • English-speaking
  • not pregnant
  • no weekly practice of yoga, qi gong, tai chi, dance/movement therapy, or mindfulness meditation practice

Exclusion Criteria:

  • Males with breast cancer
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02619292
Other Study ID Numbers  ICMJE MMP-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party John Wayne Cancer Institute
Study Sponsor  ICMJE John Wayne Cancer Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rebecca Crane-Okada, PhD, RN John Wayne Cancer Institute
PRS Account John Wayne Cancer Institute
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP