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
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Mindful Movement Program for Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • 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 ]

Enrollment: 49
Study Start Date: August 2008
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Rebecca Crane-Okada, PhD Beckman Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00903474     History of Changes
Other Study ID Numbers: 08061, CHNMC-08061
Study First Received: May 15, 2009
Last Updated: September 11, 2012
Health Authority: United States: Institutional Review Board

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:
Anxiety Disorders
Breast Neoplasms
Depression
Depressive Disorder
Mental Disorders
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on April 17, 2014