Clinical trial NCT00507923: Tibetan Yoga in Improving Fatigue and Sleep in Participants With Stage I-III Breast Cancer
Official title: Effects of Tibetan Yoga on Fatigue and Sleep in Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Anatomic Stage IIIB Breast Cancer AJCC v8
Anatomic Stage IIIC Breast Cancer AJCC v8
Prognostic Stage I Breast Cancer AJCC v8
Prognostic Stage IA Breast Cancer AJCC v8
Prognostic Stage IB Breast Cancer AJCC v8
Prognostic Stage II Breast Cancer AJCC v8
Prognostic Stage IIA Breast Cancer AJCC v8
Prognostic Stage IIB Breast Cancer AJCC v8
Prognostic Stage III Breast Cancer AJCC v8
Prognostic Stage IIIA Breast Cancer AJCC v8
Prognostic Stage IIIB Breast Cancer AJCC v8
Prognostic Stage IIIC Breast Cancer AJCC v8
Breast Cancer
Keywords: Breast Cancer
Tibetan Yoga
Stretching
Yoga
Fatigue
Sleep
Questionnaire
Survey
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-07-27
Enrollment: 452
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The correlation on the effects of Tibetan yoga on fatigue
timeFrame: Up to 12 months
measure: The correlation on the effects of Tibetan yoga on sleep disturbances
timeFrame: Up to 12 months
measure: Identifying the process of the underlying efficacy of Tibetan yoga intervention.
timeFrame: Up to 12 months
measure: The Effects of Tibetan Yoga Program with the aspects of adjustment.
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lorenzo Cohen
role: PRINCIPAL_INVESTIGATOR
References: