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

Breast Cancer Clinical Trial

Official title:

Mindful Movement Program for Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00903474
• Other study ID #: 08061
• Secondary ID: CHNMC-08061
• Status: Completed
• Phase: N/A
• First received: May 15, 2009
• Last updated: June 3, 2015
• Start date: August 2008
• Est. completion date: April 2010

Study information

• Verified date: June 2015
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Breast Cancer
• Breast Neoplasms
• Cancer Survivor
• Cognitive/Functional Effects
• Depression
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Other:
• questionnaire administration

• study of socioeconomic and demographic variables

Procedure:
• CAM exercise therapy

• psychosocial assessment and care

• quality-of-life assessment

• stress management therapy

Locations

Country	Name	City	State
United States	City of Hope Comprehensive Cancer Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Effects of this program on attention and attitude		6 months after study entry	No
Primary	Differences of attention and attitude between the experimental group and the control group		6 months after study entry	No
Primary	Perceptions of the program as described by the experimental group		6 months after entry	No