Anxiety Disorder, Breast Cancer, Cancer Survivor, Cognitive/Functional Effects, Depression, Psychosocial Effects of Cancer and Its Treatment
Conditions
Keywords
anxiety disorder, depression, cognitive/functional effects, psychosocial effects of cancer and its treatment, cancer survivor, breast cancer
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.
Interventions
OTHERquestionnaire administration
OTHERstudy of socioeconomic and demographic variables
PROCEDURECAM exercise therapy
PROCEDUREpsychosocial assessment and care
PROCEDUREquality-of-life assessment
PROCEDUREstress management therapy
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Effects of this program on attention and attitude | 6 months after study entry |
| Differences of attention and attitude between the experimental group and the control group | 6 months after study entry |
| Perceptions of the program as described by the experimental group | 6 months after entry |
Countries
United States
Outcome results
None listed