Clinical trial NCT00903474: Mindful Movement Program in Improving Quality of Life in Older Female Breast Cancer Survivors
Official title: Mindful Movement Program for Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorder
Breast Cancer
Cancer Survivor
Cognitive/Functional Effects
Depression
Psychosocial Effects of Cancer and Its Treatment
Keywords: anxiety disorder
depression
cognitive/functional effects
psychosocial effects of cancer and its treatment
cancer survivor
breast cancer
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-18
Enrollment: 49
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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 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

Primary outcomes:
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
timeFrame: 6 months after study entry
measure: Effects of this program on attention and attitude
timeFrame: 6 months after study entry
measure: Differences of attention and attitude between the experimental group and the control group
timeFrame: 6 months after study entry
measure: Perceptions of the program as described by the experimental group
timeFrame: 6 months after entry
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
Study officials:
affiliation: City of Hope Comprehensive Cancer Center
name: Rebecca Crane-Okada, PhD
role: PRINCIPAL_INVESTIGATOR
References: