NCT00903474

Brief Summary

RATIONALE: Mindful movement is a self-directed activity of mindfulness (intention, attention, and attitude) and physical movement. A mindful movement program may be effective in improving well-being in older women who are breast cancer survivors. PURPOSE: This randomized clinical trial is studying how well a mindful movement program works in improving quality of life in older female breast cancer survivors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2008

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

1.7 years

First QC Date

May 15, 2009

Last Update Submit

June 3, 2015

Conditions

Keywords

anxiety disorderdepressioncognitive/functional effectspsychosocial effects of cancer and its treatmentcancer survivorbreast cancer

Outcome Measures

Primary Outcomes (4)

  • Effects of the Mindful Movement Program on psychological well-being, distress, fear of recurrence, physical well-being, upper-body symptom bother, social well-being, body image, and spiritual well-being at baseline and weeks 12 and 18

    6 months after study entry

  • Effects of this program on attention and attitude

    6 months after study entry

  • Differences of attention and attitude between the experimental group and the control group

    6 months after study entry

  • Perceptions of the program as described by the experimental group

    6 months after entry

Interventions

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Breast cancer survivor * At least 12 months since completion of treatment (chemotherapy, biotherapy \[e.g., trastuzumab\], or radiotherapy) * No evidence of metastatic disease PATIENT CHARACTERISTICS: * English speaking * Not under acute psychological distress * Not using an assistive device (cane, walker, or wheelchair) * Able to participate in the Mindful Movement Program by a medical release from the patient's physician * Pregnancy allowed PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Concurrent selective estrogen-receptor modulator permitted * No other concurrent treatment

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Anxiety DisordersBreast NeoplasmsDepression

Interventions

Exercise TherapyPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Mental DisordersNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Rebecca Crane-Okada, PhD

    City of Hope Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2009

First Posted

May 18, 2009

Study Start

August 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations