Anatomic Stage I Breast Cancer AJCC v8NCT00507923
Tibetan Yoga in Improving Fatigue and Sleep in Participants With Stage I-III Breast Cancer
A study testing Actigraph, Best Practice and Quality-of-Life Assessment in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
- What is being tested?
- Actigraph, Best Practice and Quality-of-Life Assessment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2006to 11 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- 18 years of age or older.
- Able to read, write and speak English
- Able to come to UTMDACC for intervention and assessment sessions.
Who cannot join
- Metastatic disease of the bone.
- Documented diagnosis of a formal thought disorder (e.g., schizophrenia).
- Engaged in psychiatric or psychological counseling or support groups.
- Reports the need for psychological services.
- Score of 23 or below on the Mini-Mental State Examination.
- Presence of lymphedema at the start of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Tibetan Yoga on Fatigue and Sleep in Cancer
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.
Read the 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 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
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Being tested
- Actigraph, Best Practice, Quality-of-Life Assessment, Questionnaire Administration, Sleep Diary
- Keywords
- Breast Cancer, Tibetan Yoga, Stretching, Yoga, Fatigue, Sleep, Questionnaire, Survey
- Medical subject headings
- Breast Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActigraphDevice
Also called Actigram
Wear actigraph
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Sleep DiaryOther
Also called Sleep Journal, Sleep Log
Complete sleep diary
StretchingOther
Participate in stretching sessions
YogaProcedure or surgery
Also called Yoga Therapy
Participate in Tibetan yoga
| Study group | Role | What they receive |
|---|---|---|
| Group I (Tibetan yoga) | Experimental | 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. Receives: Device: Actigraph; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Sleep Diary; Procedure: Yoga |
| Group II (stretching) | Active comparator | 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. Receives: Device: Actigraph; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Sleep Diary; Other: Stretching |
| Group III (usual care) | Active comparator | 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. Receives: Device: Actigraph; Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Sleep Diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation on the effects of Tibetan yoga on fatigue
Participants will be monitored on the extent to which the Tibetan Yoga program decreases fatigue and sleep disturbances. Fatigue will be assessed using the Brief Fatigue Inventory (BFI). The BFI is a 9-item questionnaire designed to be used in the clinical setting to rapidly assess fatigue severity. The items are ranked from 0 to 10, and patients rate their fatigue at its "worst" and "usual" and as it is "now," with 0 = "no fatigue" and 10 = "fatigue as bad as you can imagine." Patients also rate how much their fatigue has interfered with their life. This single-dimension instrument was tested in a sample of patients with cancer, and provided an internally stable measure of fatigue severity.
Measured: Up to 12 months
The correlation on the effects of Tibetan yoga on sleep disturbances
The Fatigue will be assessed using the Brief Fatigue Inventory (BFI), items are ranked from 1-10 and patients will rate their fatigue at its "worst" and "usual" and as it is "now" with 0= no fatigue and 10= "fatigue as bad as you can imagine". The Sleep disturbance will be assessed using the Pittsburgh Sleep Quality Index (PSQI), this 18 item questionnaire and it rates the sleep quality from 0=good and 3=very poor. The less the total score the less of a sleep disturbance problem.
Measured: Up to 12 months
Identifying the process of the underlying efficacy of Tibetan yoga intervention.
Writing will be conducted at the 3 month post intervention assessment. Participants will only conduct the writing one time as an outcome measure, which should not have an appreciable affect on the outcomes. Samples will be analyzed using Linguistic Inquiry Word Count (LIWC) software was developed to examine the linguistic content of writing samples. We used this program in our previous pilot study examining the emotional-expression writing intervention. The software counts the number of times specific words are used in the writing samples. The software recognizes more than 2,290 words and classifies them into 74 different grammatical, cognitive, and emotional categories. It can calculate the average percentage of words used in the different categories and determine changes in the percentages over writing samples. Writings will also be assessed in an exploratory fashion using qualitative analyses, including the use of ethnographic methods.
Measured: Up to 12 months
The Effects of Tibetan Yoga Program with the aspects of adjustment.
We will assess cytotoxicity to K562 target cells; stimulated and circulating release of IL-12, IFN, IL-4, IL-6, IL-8, and IL-10 (using polyclonal stimulators); flow cytometric analysis of intracellular cytokines (to identify the subset of cells producing the particular cytokine); and lymphocyte phenotype (CD3, CD56, CD16, CD4, and CD8) [279, 280]. PBMCs will be cryopreserved for future analyses if the initial assays are encouraging. Other assays may be conducted in the future.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2007 (estimated)
- Study start7 Nov 2006
- Primary completion11 Aug 2022
- Study completion11 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lorenzo Cohen, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507923
- Sponsor's protocol ID
- 2005-0035
- Other IDs
- NCI-2018-01753, 2005-0035, R01CA105023
- Status last verified
- Mar 2023
- First submitted
- 25 Jul 2007
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tibetan Yoga on Fatigue and Sleep in Cancer
- ClinicalTrials.gov ID
- NCT00507923
- Acronym / sponsor ID
- 2005-0035
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Keywords
- Breast Cancer, Tibetan Yoga, Stretching, Yoga, Fatigue, Sleep, Questionnaire, Survey
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Nov 2006 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 27 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (Tibetan yoga) | Experimental | Device: Actigraph, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Sleep Diary, Procedure: YogaParticipants 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. |
| Group II (stretching) | Active comparator | Device: Actigraph, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Sleep Diary, Other: StretchingParticipants 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. |
| Group III (usual care) | Active comparator | Device: Actigraph, Other: Best Practice, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Sleep DiaryParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
- 18 years of age or older.
- Able to read, write and speak English
- Able to come to UTMDACC for intervention and assessment sessions.
Key exclusion criteria (6 listed)
- Metastatic disease of the bone.
- Documented diagnosis of a formal thought disorder (e.g., schizophrenia).
- Engaged in psychiatric or psychological counseling or support groups.
- Reports the need for psychological services.
- Score of 23 or below on the Mini-Mental State Examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActigraphAlso: ActigramWear actigraph | Device | Group I (Tibetan yoga), Group II (stretching), Group III (usual care) |
| Best PracticeAlso: standard of care, standard therapyReceive usual care | Other | Group III (usual care) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Group I (Tibetan yoga), Group II (stretching), Group III (usual care) |
| Questionnaire AdministrationAncillary studies | Other | Group I (Tibetan yoga), Group II (stretching), Group III (usual care) |
| Sleep DiaryAlso: Sleep Journal, Sleep LogComplete sleep diary | Other | Group I (Tibetan yoga), Group II (stretching), Group III (usual care) |
| StretchingParticipate in stretching sessions | Other | Group II (stretching) |
| YogaAlso: Yoga TherapyParticipate in Tibetan yoga | Procedure or surgery | Group I (Tibetan yoga) |
Primary outcome
The correlation on the effects of Tibetan yoga on fatigue
Time frame: Up to 12 months
Participants will be monitored on the extent to which the Tibetan Yoga program decreases fatigue and sleep disturbances. Fatigue will be assessed using the Brief Fatigue Inventory (BFI). The BFI is a 9-item questionnaire designed to be used in the clinical setting to rapidly assess fatigue severity. The items are ranked from 0 to 10, and patients rate their fatigue at its "worst" and "usual" and as it is "now," with 0 = "no fatigue" and 10 = "fatigue as bad as you can imagine." Patients also rate how much their fatigue has interfered with their life. This single-dimension instrument was tested in a sample of patients with cancer, and provided an internally stable measure of fatigue severity.
The correlation on the effects of Tibetan yoga on sleep disturbances
Time frame: Up to 12 months
The Fatigue will be assessed using the Brief Fatigue Inventory (BFI), items are ranked from 1-10 and patients will rate their fatigue at its "worst" and "usual" and as it is "now" with 0= no fatigue and 10= "fatigue as bad as you can imagine". The Sleep disturbance will be assessed using the Pittsburgh Sleep Quality Index (PSQI), this 18 item questionnaire and it rates the sleep quality from 0=good and 3=very poor. The less the total score the less of a sleep disturbance problem.
Identifying the process of the underlying efficacy of Tibetan yoga intervention.
Time frame: Up to 12 months
Writing will be conducted at the 3 month post intervention assessment. Participants will only conduct the writing one time as an outcome measure, which should not have an appreciable affect on the outcomes. Samples will be analyzed using Linguistic Inquiry Word Count (LIWC) software was developed to examine the linguistic content of writing samples. We used this program in our previous pilot study examining the emotional-expression writing intervention. The software counts the number of times specific words are used in the writing samples. The software recognizes more than 2,290 words and classifies them into 74 different grammatical, cognitive, and emotional categories. It can calculate the average percentage of words used in the different categories and determine changes in the percentages over writing samples. Writings will also be assessed in an exploratory fashion using qualitative analyses, including the use of ethnographic methods.
The Effects of Tibetan Yoga Program with the aspects of adjustment.
Time frame: Up to 12 months
We will assess cytotoxicity to K562 target cells; stimulated and circulating release of IL-12, IFN, IL-4, IL-6, IL-8, and IL-10 (using polyclonal stimulators); flow cytometric analysis of intracellular cytokines (to identify the subset of cells producing the particular cytokine); and lymphocyte phenotype (CD3, CD56, CD16, CD4, and CD8) [279, 280]. PBMCs will be cryopreserved for future analyses if the initial assays are encouraging. Other assays may be conducted in the future.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenzo Cohen principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actigraph, Best Practice and Quality-of-Life Assessment in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation on the effects of Tibetan yoga on fatigue (time frame: Up to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.