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

Not Applicable

Completed

• Conditions: Cognitive/Functional Effects; Psychosocial Effects of Cancer and Its Treatment; Depression; Anxiety Disorder; Breast Cancer; Cancer Survivor

• Registration Number: NCT00903474
• Lead Sponsor: City of Hope Medical Center

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.

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 Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-05-15
• Study First Submitted QC: 2009-05-15
• Study First Posted: 2009-05-18
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States