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

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ClinicalTrials.gov Identifier: NCT00903474
Recruitment Status : Completed
First Posted : May 18, 2009
Last Update Posted : June 8, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
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
Primary Completion Date : April 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. Effects of this program on attention and attitude [ Time Frame: 6 months after study entry ]
  3. Differences of attention and attitude between the experimental group and the control group [ Time Frame: 6 months after study entry ]
  4. Perceptions of the program as described by the experimental group [ Time Frame: 6 months after entry ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903474


Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Rebecca Crane-Okada, PhD City of Hope Comprehensive Cancer Center
More Information

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00903474     History of Changes
Other Study ID Numbers: 08061
CHNMC-08061
First Posted: May 18, 2009    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015

Keywords provided by City of Hope Medical Center:
anxiety disorder
depression
cognitive/functional effects
psychosocial effects of cancer and its treatment
cancer survivor
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Depression
Anxiety Disorders
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Behavioral Symptoms
Mental Disorders