Tibetan Yoga in Improving Fatigue and Sleep in Participants With Stage I-III Breast Cancer
Effects of Tibetan Yoga on Fatigue and Sleep in Cancer
3 other identifiers
interventional
452
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 7, 2006
CompletedFirst Submitted
Initial submission to the registry
July 25, 2007
CompletedFirst Posted
Study publicly available on registry
July 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 11, 2022
CompletedMarch 27, 2023
March 1, 2023
15.8 years
July 25, 2007
March 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
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.
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.
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.
Up to 12 months
Study Arms (3)
Group I (Tibetan yoga)
EXPERIMENTALParticipants 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 COMPARATORParticipants 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 COMPARATORParticipants 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.
Interventions
Wear actigraph
Receive usual care
Ancillary studies
Ancillary studies
Complete sleep diary
Eligibility Criteria
You may qualify if:
- 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).
- years of age or older.
- Able to read, write and speak English
- Able to come to UTMDACC for intervention and assessment sessions.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lorenzo Cohen
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2007
First Posted
July 27, 2007
Study Start
November 7, 2006
Primary Completion
August 11, 2022
Study Completion
August 11, 2022
Last Updated
March 27, 2023
Record last verified: 2023-03