Tibetan Yoga in Improving Fatigue and Sleep in Participants With Stage I-III Breast Cancer
NCT ID: NCT00507923
Last Updated: 2023-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
452 participants
INTERVENTIONAL
2006-11-07
2022-08-11
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group I (Tibetan yoga)
Participants participate in Tibetan yoga sessions consisting of deep breathing or stretching exercises over 90 minutes for 4 sessions either once weekly or every 3 weeks. Participants also wear actigraph activity monitor and complete a sleep diary for 7 days. Participants receive instructional yoga audiotape and printed instructions to use at home upon completion of sessions.
Actigraph
Wear actigraph
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Sleep Diary
Complete sleep diary
Yoga
Participate in Tibetan yoga
Group II (stretching)
Participants participate in stretching exercise sessions over 90 minutes for 4 sessions either once weekly or every 3 weeks. Participants also wear actigraph activity monitor and complete a sleep diary for 7 days. Participants receive instructional yoga audiotape and printed instructions to use at home upon completion of sessions. Participants have the option to attend Tibetan yoga sessions upon completion of 12-month follow-up.
Actigraph
Wear actigraph
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Sleep Diary
Complete sleep diary
Stretching
Participate in stretching sessions
Group III (usual care)
Participants receive usual care and wear actigraph activity monitor and complete a sleep diary for 7 days. Participants have the option to attend Tibetan yoga sessions upon completion of 12-month follow-up.
Actigraph
Wear actigraph
Best Practice
Receive usual care
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Sleep Diary
Complete sleep diary
Interventions
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Actigraph
Wear actigraph
Best Practice
Receive usual care
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Sleep Diary
Complete sleep diary
Stretching
Participate in stretching sessions
Yoga
Participate in Tibetan yoga
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Lorenzo Cohen
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2018-01753
Identifier Type: REGISTRY
Identifier Source: secondary_id
2005-0035
Identifier Type: OTHER
Identifier Source: secondary_id
2005-0035
Identifier Type: -
Identifier Source: org_study_id
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