Mindful Movement Program in Improving Quality of Life in Older Female Breast Cancer Survivors
|ClinicalTrials.gov Identifier: NCT00903474|
Recruitment Status : Completed
First Posted : May 18, 2009
Last Update Posted : June 8, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Disorder Breast Cancer Cancer Survivor Cognitive/Functional Effects Depression Psychosocial Effects of Cancer and Its Treatment||Other: questionnaire administration Other: study of socioeconomic and demographic variables Procedure: CAM exercise therapy Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Procedure: stress management therapy||Not Applicable|
- 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 (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Mindful Movement Program for Breast Cancer Survivors|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
- 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 ]
- Effects of this program on attention and attitude [ Time Frame: 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 ]
- Perceptions of the program as described by the experimental group [ Time Frame: 6 months after entry ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903474
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|Principal Investigator:||Rebecca Crane-Okada, PhD||City of Hope Comprehensive Cancer Center|