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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02619292
Other study ID # MMP-001
Secondary ID
Status Completed
Phase N/A
First received November 6, 2015
Last updated July 12, 2017
Start date November 2015
Est. completion date June 2017

Study information

Verified date July 2017
Source John Wayne Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender Female
Age group 50 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Margie Petersen Breast Center at Providence Saint John's Health Center Santa Monica California

Sponsors (1)

Lead Sponsor Collaborator
John Wayne Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Fear of Recurrence Fear of recurrence as measured on Fear of Recurrence (FOR) scale 18 weeks
Other Mindfulness attention Improvement in mindfulness attitude as measured with the Mindful Attention Awareness Scale (MAAS) 18 weeks
Other Mindfulness attitude Improvement in mindfulness attitude as measured with the Experiences Questionnaire (EQ) 18 weeks
Primary Immune markers Improvement in serum markers of immune cell phenotype at week 18 18 weeks
Secondary Mindful Movement Intervention Experience Improvement in mindfulness attitude as measured on Meditative Movement Inventory (MMI) 18 weeks
Secondary Mindful Movement Intervention Experience Improvement in mindfulness attitude as measured on Perceived Exertion Scale (PES) 18 weeks
Secondary Mindful Movement Intervention Experience - Mindfulness Intention Improvement in mindfulness attitude as measured on Mindfulness Intention (modified from Segal, 1-item) 18 weeks
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