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Mindful Movement for Breast Cancer Survivors

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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

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Mindful Movement Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mindful Movement for Breast Cancer Survivors
Actual Study Start Date : November 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.




Primary Outcome Measures :
  1. Immune markers [ Time Frame: 18 weeks ]
    Improvement in serum markers of immune cell phenotype at week 18


Secondary Outcome Measures :
  1. Mindful Movement Intervention Experience [ Time Frame: 18 weeks ]
    Improvement in mindfulness attitude as measured on Meditative Movement Inventory (MMI)

  2. Mindful Movement Intervention Experience [ Time Frame: 18 weeks ]
    Improvement in mindfulness attitude as measured on Perceived Exertion Scale (PES)

  3. Mindful Movement Intervention Experience - Mindfulness Intention [ Time Frame: 18 weeks ]
    Improvement in mindfulness attitude as measured on Mindfulness Intention (modified from Segal, 1-item)


Other Outcome Measures:
  1. Fear of Recurrence [ Time Frame: 18 weeks ]
    Fear of recurrence as measured on Fear of Recurrence (FOR) scale

  2. Mindfulness attention [ Time Frame: 18 weeks ]
    Improvement in mindfulness attitude as measured with the Mindful Attention Awareness Scale (MAAS)

  3. Mindfulness attitude [ Time Frame: 18 weeks ]
    Improvement in mindfulness attitude as measured with the Experiences Questionnaire (EQ)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02619292


Locations
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United States, California
Margie Petersen Breast Center at Providence Saint John's Health Center
Santa Monica, California, United States, 90404
Sponsors and Collaborators
John Wayne Cancer Institute
Investigators
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Principal Investigator: Rebecca Crane-Okada, PhD, RN John Wayne Cancer Institute

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Responsible Party: John Wayne Cancer Institute
ClinicalTrials.gov Identifier: NCT02619292     History of Changes
Other Study ID Numbers: MMP-001
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by John Wayne Cancer Institute:
cancer survivor
immune function

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases