Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00507923 |
| Other study ID # |
2005-0035 |
| Secondary ID |
NCI-2018-0175320 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 7, 2006 |
| Est. completion date |
August 11, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
M.D. Anderson Cancer Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this behavioral research study is to learn if participating in a Tibetan yoga
program helps to improve quality of life for women during treatment for or recovery from
breast cancer. Researchers are also interested in whether the yoga program helps to improve
sleep, lung function, and physical therapy, based on outcomes.
Description:
You will come to M. D. Anderson for an initial meeting. You will complete several
questionnaires asking about mood, quality of life, and other things like sleep, fatigue,
anxiety, and coping skills. You will also have an electrocardiogram (ECG - a test to measure
the electrical activity of your heart). Both the questionnaires and the ECG test should take
about 60 minutes, total, to complete.
You will also wear an actigraph (a watch-like instrument that records arm movements) for 7
days. The actigraph records information about your physical activity, rest, and sleep. You
will be asked to complete daily sleep diary forms that ask about some behaviors, your sleep,
and sleep quality for the 7 days. At the end of the 7 days, you will return the actigraph and
sleep diaries to the research staff, or a member of the research staff can go to your home to
pick them up.
If you are assigned to the yoga group, you will take part in 4 weekly sessions of Tibetan
yoga. If you are not able to attend 4 weekly sessions, you can attend 1 session every 3
weeks, for a total of 4 sessions over 12 weeks, of Tibetan yoga. You will be asked to
complete a brief form at the start of each session that will take 1-2 minutes to complete.
During the yoga sessions, you will be asked to do deep breathing exercises and perform
different stretching and movement exercises. You will be able to move through the exercises
at your own pace. Sessions occurring weekly will last 90 minutes. Sessions occurring once
every 3 weeks will last 90 minutes. All sessions will be provided free of charge. One or more
of these yoga sessions may be videotaped by the study staff for quality assurance purposes.
Only the study staff will be able to view this videotape.
If you are assigned to the stretching group, you will take part in 4 weekly sessions in which
you will be asked to do simple stretching exercises. If you are not able to attend 4 weekly
sessions, you can attend 1 session every 3 weeks, for a total of 4 sessions over 12 weeks.
Sessions occurring weekly will last 90 minutes. Sessions occurring once every 3 weeks will
last 90 minutes. All sessions will be provided free of charge. None of the movements are
difficult. You will be able to follow this program at your own pace.
If you are assigned to the yoga or stretching group, you will take part in 3 "booster"
sessions consisting of a review and practice of the entire program. If you are in the 4
weekly sessions, your booster sessions will take place 1 and 2 months after your last yoga or
stretch class and again around the time of your 6-month assessment. If you are in the classes
that meet every 3 weeks over a 12-week period, your booster sessions will take place 3 and 6
weeks after your last yoga or stretch class and again around the time of your 6-month
assessment.
If a need for counseling/therapy arises, your primary care physician will be notified and can
refer you to the Section of Psychiatry, Department of Neuro-Oncology.
One week, 3 months, 6 months, and 12 months after the end of the yoga or stretching sessions
(or similar time for the usual care group), you will be asked to return to the clinic. You
will fill out a packet of questionnaires and complete an ECG evaluation again. The
questionnaires and tests should take about 60 minutes to complete. You will also be asked to
wear the actigraph and complete daily sleep diary forms for another 7 days. At the end of the
7 days, you will return the actigraph and sleep diaries to the research staff, or a member of
the research staff can go to your home to pick them up. This will be your last participation
in the study.
After the study is over, if you took part in the stretching or were in the usual care group,
you will be given the option to take the yoga classes.
