Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Fatigue

Breast Diseases

Skin Diseases

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.

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.

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

Best Practice

Quality-of-Life Assessment

Questionnaire Administration

Sleep Diary

Stretching

Yoga

Lorenzo Cohen

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.

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.

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

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 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.

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.

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.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Behaviors and Mental Disorders

Quality of Life

3 sessions of yoga each week for 6 weeks. Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy.

3 sessions of stretching each week for 6 weeks. Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy.

Option of participating in the yoga or stretching program after the study has ended. Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy.

3 sessions of yoga each week for 6 weeks.

Yoga Group

3 sessions of stretching each week for 6 weeks

Stretching Control Group

Option of participating in the yoga or stretching program after the study has ended.

Waitlist Control Group

Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy.

Questionnaire

Lorenzo Cohen, PhD

In this study researchers will examine the initial efficacy of implementing a yoga program for patients with breast cancer as an adjuvant to their radiotherapy. Patients with breast cancer who are undergoing radiotherapy will be randomly assigned to either a yoga group (YG), or a stretching (ST) control group, or a waitlist control (WL) group. Participants in YG and ST groups will attend three sessions each week throughout their 6-week radiotherapy schedule. The sessions will be coordinated with the treatment schedule and conducted adjacent to the treatment facility. Measures will be obtained prior to randomization, a brief assessment during the middle of radiation therapy, during the last week of radiation therapy, and 1, 3 and 6 months after the last radiation session. With the inclusion of two control groups in this randomized trial researchers will attempt to validate the benefits of yoga as an adjuvant to radiotherapy in patients with breast cancer wherein researchers will control for specific components of the yoga program and also examine some of the mechanisms that are necessary for the program to be effective.

Our specific aims in the proposed study are to:

* Conduct an initial evaluation of whether participation in the yoga program improves patients' fatigue and sleep disturbances. Fatigue and sleep will be assessed with self-report measures and the use of actigraphy for a more objective measure of sleep quality.
* Secondary end points will include examining QOL, mental health and objective physiological outcomes (blood samples for immune measures, saliva samples for cortisol levels, and heart rate variability).
* Exploratory analyses will examine some plausible mediators of the yoga program including cognitive processing, spirituality, and finding meaning in the cancer experience.

If you choose to take part in this study, you will come to M. D. Anderson for your first visit. If this is not convenient, a researcher can visit you at your home. At this time, you will be asked to complete several questionnaires. The questions will ask about your sleeping habits, how you have been feeling, and your general QOL. This will take about 45-60 minutes to complete. Researchers, will then ask you to complete a daily sleep diary for the next 7 days. During this time, you will be given an actigraph watch to wear that will collect data about your day-time activity and sleeping habits. The watch should be worn 24 hours a day for 7 days a week. You will have an electrocardiogram (ECG - a test to measure the electrical activity of your heart) and your breathing rate will be measured.

After your first visit to M. D. Anderson or after a researcher has visited you at home, you will be randomly assigned (as in the toss of a coin) to one of 3 groups.

Participants in the first group will take part in a yoga program. If you are assigned to the yoga group, you will take part in 3 sessions of yoga each week for 6 weeks. You may take part in the yoga sessions any 3 days of the week. Each yoga session will last around 60 minutes. During the yoga sessions, you will also be asked to do breathing exercises and to perform different movements and meditation. None of the movements are difficult. You will be able to follow this program at your own pace.

Participants in the second group will take part in a stretching program. If you are assigned to the stretching group, you will take part in 3 sessions of stretching each week for 6 weeks. You may take part in the stretching sessions any 3 days of the week. Each stretching session will last around 60 minutes. During these stretching sessions you will be asked to do simple stretching exercises. None of the movements are difficult. You will be able to follow this program at your own pace.

Beginning with the second week, participants in the first and second groups will be asked to complete a brief questionnaire, about the yoga or stretching program, before the first class each week. The questionnaire will take about 1 to 2 minutes to complete. You will also have an ECG and your breathing rate will be measured before and after one of the classes during the third or fourth week and again during the last week. Each stretching and yoga session will be audio and video taped for the purpose of quality control.

Participants in the third group will not take part in the yoga or stretching program during this study. However, if you are assigned to this group, you will be given the option of participating in the yoga or stretching program after the study has ended. This will be after you have finished your last assessment.

All participants will complete a brief questionnaire during the middle of radiotherapy. The questionnaire will evaluate your treatment-related symptoms and will take about 15 minutes to complete.

During the last week of radiotherapy, and at 1, 3, and 6 months after the end of radiation treatment, all participants will be asked to fill out a packet of questionnaires (similar to those taken at the first visit). It should take about 45 minutes to complete all of the questionnaires. If it is not convenient for you to come to M. D. Anderson, a researcher can visit you at home to help with the questionnaires. You will then be asked to complete another daily sleep diary for another 7 days. During this time, you will wear an actigraph watch 24 hours a day for 7 days a week to collect the same data as before. During this time, you will have an ECG and your breathing rate will be measured.

All participants will be asked to refrain from participating in any other yoga classes for the duration of the study.

Your participation in this study will be over after your 6-month assessment.

This is an investigational study. Up to 180 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Tibetan Yoga in Improving Fatigue and Sleep in Participants With Stage I-III Breast Cancer	NCT00507923	Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Breast Cancer	Actigraph Best Practice Quality-of-Life... Questionnaire A... Sleep Diary Stretching Yoga	18 Years -	M.D. Anderson Cancer Center
Effects of Yoga in Breast Cancer Patients	NCT00508794	Breast Cancer	Yoga Group Stretching Cont... Waitlist Contro... Questionnaire	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for tibetan yoga

Every month we try and update this database with for tibetan yoga cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.