This pilot clinical trial studies interactive gentle yoga in improving quality of life in patients with stage I-III breast cancer undergoing radiation therapy. Interactive gentle yoga may improve the quality of life in patients with breast cancer undergoing radiation therapy.
PRIMARY OBJECTIVES: I. To determine the feasibility of implementing a 6-week biweekly yoga intervention delivered by multi-point videoconferencing in breast cancer patients undergoing radiation therapy. SECONDARY OBJECTIVES: I. To obtain preliminary data on changes in depression, anxiety, fatigue, sleep quality pre- and post-intervention in women with breast cancer undergoing radiation therapy. II. To obtain preliminary data on acute effects of the yoga classes on fatigue and distress. OUTLINE: Participants undergo 12 sessions of cancer-adapted integral yoga classes using an internet-based videoconferencing platform. Integral yoga includes postures, deep relaxation, breathing practices and meditation to create a profound experience of peace and well-being. Participants take part in study classes from home (or other location that is convenient for the participant and that allows them to access the internet-based classes) with two-way interaction with group instructors and members alike over 75 minutes twice weekly for 6 weeks during radiation therapy. Participants are encouraged to complete additional yoga practice sessions outside of the twice weekly study sessions. After completion of study, participants are followed up at 1 week.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
6
Undergo integral yoga intervention with videoconferencing
Undergo integral yoga intervention with videoconferencing
Ancillary studies
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Recruitment rates, calculated as the number of women enrolled divided by the number of women who screened eligible for the study
Time frame: Up to week 7
Retention rates, calculated as the proportion of enrolled women who complete all study measures at each time point
Time frame: Up to week 7
Adherence, measured by the total number of yoga classes attended by each participant
Time frame: Up to week 7
Participants' acceptability of the intervention, including ratings of ease/difficulty of use of the videoconferencing and participating in group classes from home using the device
The proportions and 95% confidence intervals will be calculated. Descriptive statistics will be computed.
Time frame: Up to week 7
Feedback regarding the participants' experience in the study
Qualitative analysis of open-ended feedback on strengths and weaknesses of the yoga intervention and teacher, use of the multi-point videoconferencing device will be performed.
Time frame: Up to week 7
Change in depression as measured by HADS
Computed using a mixed model analysis to account for the repeated measures on each subject.
Time frame: Baseline up to 7 weeks
Change in anxiety as measured by HADS
Computed using a mixed model analysis to account for the repeated measures on each subject.
Time frame: Baseline up to 7 weeks
Change in fatigue as measured by visual analogue scale and Functional Assessment of Cancer Therapy-Fatigue
Computed using a mixed model analysis to account for the repeated measures on each subject. Assessed by calculating the difference in the post and pre scores for each session, and then examining whether there is a time effect using a mixed model.
Time frame: Baseline up to 7 weeks
Change in sleep quality as measured by Pittsburgh Sleep Quality Inventory
Computed using a mixed model analysis to account for the repeated measures on each subject.
Time frame: Baseline up to 7 weeks
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