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

Study Overview
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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.

Official Title
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Mindful Movement Program for Breast Cancer Survivors

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

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: questionnaire administration|nan|
|Other: study of socioeconomic and demographic variables|nan|
|Procedure: CAM exercise therapy|nan|
|Procedure: psychosocial assessment and care|nan|
|Procedure: quality-of-life assessment|nan|
|Procedure: stress management therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety disorder, depression, cognitive/functional effects, psychosocial effects of cancer and its treatment, breast cancer, cancer survivor