Mindful Movement for Breast Cancer Survivors

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Mindful Movement Program

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: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Margie Petersen Breast Center at Providence Saint John's Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune markers	Improvement in serum markers of immune cell phenotype at week 18	18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mindful Movement Intervention Experience	Improvement in mindfulness attitude as measured on Meditative Movement Inventory (MMI)	18 weeks
Mindful Movement Intervention Experience	Improvement in mindfulness attitude as measured on Perceived Exertion Scale (PES)	18 weeks
Mindful Movement Intervention Experience - Mindfulness Intention	Improvement in mindfulness attitude as measured on Mindfulness Intention (modified from Segal, 1-item)	18 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear of Recurrence	Fear of recurrence as measured on Fear of Recurrence (FOR) scale	18 weeks
Mindfulness attention	Improvement in mindfulness attitude as measured with the Mindful Attention Awareness Scale (MAAS)	18 weeks
Mindfulness attitude	Improvement in mindfulness attitude as measured with the Experiences Questionnaire (EQ)	18 weeks

Collaborators and Investigators

• Sponsor: Saint John's Cancer Institute
• Investigators: Principal Investigator: Rebecca Crane-Okada, PhD, RN, Saint John's Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: November 6, 2015
• First Submitted That Met QC Criteria: November 30, 2015
• First Posted (Estimate): December 2, 2015

Study Record Updates

• Last Update Posted (Actual): July 14, 2017
• Last Update Submitted That Met QC Criteria: July 12, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: cancer survivor; immune function
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: MMP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No