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Effects of Tibetan Yoga on Fatigue and Sleep in Cancer


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

Effects of Tibetan Yoga on Fatigue and Sleep in Cancer


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.

You will then be randomly assigned (as in the toss of a coin) to one of three groups.
People in the first group will take part in a Tibetan yoga program. People in another group
will take part in stretching program. People in the third group will get usual care.
People in the stretching and usual care groups will be given the opportunity to take part in
the Tibetan yoga program, after the end of the study.

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.

This is an investigational study. As many as 480 patients could take part in this study.
All will be enrolled at M. D. Anderson.


Inclusion Criteria:



1. Women with stage I-III breast cancer who are undergoing neoadjuvant or adjuvant
chemotherapy weekly for 12 weeks followed by four cycles of an anthracycline-based
treatment every 21 days or six to eight cycles of chemotherapy every 21 days or are
within 24 months post-treatment (surgery and/or chemotherapy and/or radiotherapy -
patients can still be taking hormonal treatment).

2. 18 years of age or older.

3. Able to read, write and speak English

4. Able to come to UTMDACC for intervention and assessment sessions.

Exclusion Criteria:

1. Metastatic disease of the bone.

2. Documented diagnosis of a formal thought disorder (e.g., schizophrenia).

3. Engaged in psychiatric or psychological counseling or support groups.

4. Reports the need for psychological services.

5. Score of 23 or below on the Mini-Mental State Examination.

6. Presence of lymphedema at the start of the study.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Assessments of Fatigue

Outcome Time Frame:

1 month assessment

Safety Issue:

No

Principal Investigator

Lorenzo Cohen, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2005-0035

NCT ID:

NCT00507923

Start Date:

November 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Tibetan Yoga
  • Stretching
  • Yoga
  • Fatigue
  • Sleep
  • Questionnaire
  • Survey
  • Breast Neoplasms
  • Fatigue

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030