NCT02619292

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2015

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

November 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 14, 2017

Status Verified

July 1, 2017

Enrollment Period

1.6 years

First QC Date

November 6, 2015

Last Update Submit

July 12, 2017

Conditions

Keywords

cancer survivorimmune function

Outcome Measures

Primary Outcomes (1)

  • Immune markers

    Improvement in serum markers of immune cell phenotype at week 18

    18 weeks

Secondary Outcomes (3)

  • Mindful Movement Intervention Experience

    18 weeks

  • Mindful Movement Intervention Experience

    18 weeks

  • Mindful Movement Intervention Experience - Mindfulness Intention

    18 weeks

Other Outcomes (3)

  • Fear of Recurrence

    18 weeks

  • Mindfulness attention

    18 weeks

  • Mindfulness attitude

    18 weeks

Study Arms (1)

Mindful Movement Program

EXPERIMENTAL

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

Interventions

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.

Mindful Movement Program

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed at age 50 or older with stage 0-III disease
  • 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

You may not qualify if:

  • Males with breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Margie Petersen Breast Center at Providence Saint John's Health Center

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Rebecca Crane-Okada, PhD, RN

    Saint John's Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2015

First Posted

December 2, 2015

Study Start

November 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

July 14, 2017

Record last verified: 2017-07

Locations