Mindful Movement Program in Improving Quality of Life in Older Female Breast Cancer Survivors

NCT ID: NCT00903474

Last Updated: 2015-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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OBJECTIVES:

* To test the effects of the 12-week Mindful Movement Program on quality of life in older female breast cancer survivors.
* To test the effects of this program on mindfulness outcomes in these participants.
* To compare mindfulness qualities in the experimental group with the control group.
* To determine the qualitative benefits of this program as described by these participants.

OUTLINE: Participants are randomized to 1 of 2 intervention arms.

* Arm I (Mindful Movement Program \[MMP\]): Participants undergo a 2-hour MMP session once weekly for 12 weeks. Participants are encouraged to practice intentional-mindful movement at home 5 minutes daily during weeks 1-4, 10 minutes daily during weeks 5-8, and 15 minutes daily during weeks 9-12. Mindful movement is a self-directed activity incorporating mindfulness concepts and physical movement. Mindfulness consists of the three core elements: intention (reasons for participating in a mindfulness intervention), attention (observing experiences in the present moment), and attitude (nonjudgmental openness and acceptance of experiences). Each MMP session includes verbal sharing with a partner and the group and movement individually and with a partner, while focusing on the elements of mindfulness. Music is incorporated into some portion of each session.
* Arm II (control): Participants undergo no intervention. All participants complete questionnaires for sociodemographic and individual characteristics, quality of life (including psychological, social, spiritual, and physical well-being, anxiety and depression, fear of recurrence, body image, and upper body symptoms), movement, and mindfulness (including attention, self-compassion, and intention) at baseline and weeks 12 and 18.

PROJECTED ACCRUAL: A total of 75 participants (45 in the experimental group and 30 in the control group) will be accrued for this study.

Conditions

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Anxiety Disorder Breast Cancer Cancer Survivor Cognitive/Functional Effects Depression Psychosocial Effects of Cancer and Its Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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questionnaire administration

Intervention Type OTHER

study of socioeconomic and demographic variables

Intervention Type OTHER

CAM exercise therapy

Intervention Type PROCEDURE

psychosocial assessment and care

Intervention Type PROCEDURE

quality-of-life assessment

Intervention Type PROCEDURE

stress management therapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca Crane-Okada, PhD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Comprehensive Cancer Center

Locations

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City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status

Countries

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United States

Other Identifiers

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CHNMC-08061

Identifier Type: -

Identifier Source: secondary_id

08061

Identifier Type: -

Identifier Source: org_study_id

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