Biobehavioral Effects of Yoga During Breast Cancer Treatment
If you choose to take part in this study, you will come to M. D. Anderson for your first
visit. If this is not convenient, a researcher can visit you at your home. At this time,
you will be asked to complete several questionnaires. The questions will ask about your
sleeping habits, how you have been feeling, and your general QOL. This will take about 45-60
minutes to complete. Researchers, will then ask you to complete a daily sleep diary for the
next 7 days. During this time, you will be given an actigraph watch to wear that will
collect data about your day-time activity and sleeping habits. The watch should be worn 24
hours a day for 7 days a week. You will have an electrocardiogram (ECG - a test to measure
the electrical activity of your heart) and your breathing rate will be measured.
After your first visit to M. D. Anderson or after a researcher has visited you at home, you
will be randomly assigned (as in the toss of a coin) to one of 3 groups.
Participants in the first group will take part in a yoga program. If you are assigned to the
yoga group, you will take part in 3 sessions of yoga each week for 6 weeks. You may take
part in the yoga sessions any 3 days of the week. Each yoga session will last around 60
minutes. During the yoga sessions, you will also be asked to do breathing exercises and to
perform different movements and meditation. None of the movements are difficult. You will be
able to follow this program at your own pace.
Participants in the second group will take part in a stretching program. If you are assigned
to the stretching group, you will take part in 3 sessions of stretching each week for 6
weeks. You may take part in the stretching sessions any 3 days of the week. Each stretching
session will last around 60 minutes. During these stretching sessions you will be asked to
do simple stretching exercises. None of the movements are difficult. You will be able to
follow this program at your own pace.
Beginning with the second week, participants in the first and second groups will be asked to
complete a brief questionnaire, about the yoga or stretching program, before the first class
each week. The questionnaire will take about 1 to 2 minutes to complete. You will also have
an ECG and your breathing rate will be measured before and after one of the classes during
the third or fourth week and again during the last week. Each stretching and yoga session
will be audio and video taped for the purpose of quality control.
Participants in the third group will not take part in the yoga or stretching program during
this study. However, if you are assigned to this group, you will be given the option of
participating in the yoga or stretching program after the study has ended. This will be
after you have finished your last assessment.
All participants will complete a brief questionnaire during the middle of radiotherapy. The
questionnaire will evaluate your treatment-related symptoms and will take about 15 minutes
During the last week of radiotherapy, and at 1, 3, and 6 months after the end of radiation
treatment, all participants will be asked to fill out a packet of questionnaires (similar to
those taken at the first visit). It should take about 45 minutes to complete all of the
questionnaires. If it is not convenient for you to come to M. D. Anderson, a researcher can
visit you at home to help with the questionnaires. You will then be asked to complete
another daily sleep diary for another 7 days. During this time, you will wear an actigraph
watch 24 hours a day for 7 days a week to collect the same data as before. During this
time, you will have an ECG and your breathing rate will be measured.
All participants will be asked to refrain from participating in any other yoga classes for
the duration of the study.
Your participation in this study will be over after your 6-month assessment.
This is an investigational study. Up to 180 patients will take part in this study. All will
be enrolled at M. D. Anderson.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Fatigue and sleep assessed with self-report measures and actigraphy.
Measures will be obtained prior to randomization, a brief assessment during the middle of radiation therapy, during the last week of radiation therapy, and 1, 3 and 6 months after the last radiation session.
Lorenzo Cohen, PhD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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