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

June 3, 2015 updated by: City of Hope Medical Center

Mindful Movement Program for Breast Cancer Survivors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Duarte, California, United States, 91010-3000
    - City of Hope Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Time Frame: 6 months after study entry	6 months after study entry
Effects of this program on attention and attitude Time Frame: 6 months after study entry	6 months after study entry
Differences of attention and attitude between the experimental group and the control group Time Frame: 6 months after study entry	6 months after study entry
Perceptions of the program as described by the experimental group Time Frame: 6 months after entry	6 months after entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Rebecca Crane-Okada, PhD, City of Hope Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

May 15, 2009

First Submitted That Met QC Criteria