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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00903474
First received: May 15, 2009
Last updated: September 11, 2012
Last verified: September 2012

May 15, 2009
September 11, 2012
August 2008
April 2010   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • Effects of this program on attention and attitude [ Time Frame: 6 months after study entry ] [ Designated as safety issue: No ]
  • Differences of attention and attitude between the experimental group and the control group [ Time Frame: 6 months after study entry ] [ Designated as safety issue: No ]
  • Perceptions of the program as described by the experimental group [ Time Frame: 6 months after entry ] [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Effects of this program on attention and attitude [ Designated as safety issue: No ]
  • Differences of attention and attitude between the experimental group and the control group [ Designated as safety issue: No ]
  • Perceptions of the program as described by the experimental group [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00903474 on ClinicalTrials.gov Archive Site
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Mindful Movement Program in Improving Quality of Life in Older Female Breast Cancer Survivors
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
Not Provided
April 2010   (final data collection date for primary outcome measure)

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
Female
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00903474
08061, CHNMC-08061
Yes
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Rebecca Crane-Okada, PhD Beckman Research Institute
City of Hope Medical Center
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP