Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00507923
Status:
COMPLETED
Last Update Posted:
2023-03-27
First Post:
2007-07-25
Brief Title:
Tibetan Yoga in Improving Fatigue and Sleep in Participants With Stage I-III Breast Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Effects of Tibetan Yoga on Fatigue and Sleep in Cancer
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 counselingtherapy 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
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 counselingtherapy 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2018-01753 | REGISTRY | None | None |
| 2005-0035 | OTHER | None | None |
| R01CA105023 | NIH | M D Anderson Cancer Center | httpsreporternihgovquickSearchR01CA105023 |