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Completed

NCT Number: NCT00903474

Mindful Movement Program in Improving Quality of Life in Older Female 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.

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Key information

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire Administration

Other

study of socioeconomic and demographic variables

Other

CAM exercise therapy

Procedure

psychosocial assessment and care

Procedure

quality-of-life assessment

Procedure

Stress Management Therapy

Procedure

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Mindful Movement Program for Breast Cancer Survivors

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 18, 2009
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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