MDACC Study Summary 2005-0035

Study Summary
No. 2005-0035:.......Breast......Lorenzo Cohen......Behavioral Science

Study Summary Title



Study Summary Number:	2005-0035

Study Title:	Effects of Tibetan Yoga on Fatigue and Sleep in Cancer

Physician

New Patient Referral



Name:	Lorenzo Cohen	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Behavioral Science	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-4260 Contact us about clinical trials

General Information



Disease Group:	Breast	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	N/A

Treatment Agents:	None	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	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.

Study Objectives / Outcomes

The proposed study will assess the physical and psychological benefits of a Tibetan yoga (TY) program for women with breast cancer undergoing chemotherapy or after treatment has ended. Patients with breast cancer who are scheduled to undergo neoadjuvant or adjuvant chemotherapy or are within 24 months of having completed treatment (chemotherapy and/or radiotherapy) will be randomly assigned to a TY group, stretching group (SG) or a usual care (UC) group. The SG group will control for some of the indirect benefits of TY (e.g., attention and social support). Participants in the TY and SG groups will each participate in four weekly group sessions or 4 sessions every 3 weeks. Measures will be obtained prior to randomization and 1 week, 1 month, 6 months, and 12 months after the last intervention session.

Specific objectives of the proposed research are:

1. Evaluate the TY program in women with breast cancer undergoing chemotherapy or after treatment has ended. Our primary aim will be to determine the extent to which the TY program decreases fatigue and sleep disturbances during and after treatment.

2. Determine the effects of the TY program on other aspects of adjustment. This will consist of examining indices of QOL, mental health, physical health, work and/or home productivity, and distress.

3. Identify some of the processes underlying the efficacy of the intervention. A cognitive-social model drawn from existing research on trauma and the management of life-threatening illnesses will be evaluated to identify factors that mediate and/or moderate the effects of the intervention and predict adjustment. We will evaluate cognitive/emotional processing, social network/interactions, coping, ability to find meaning in the illness experience, spirituality, and optimism.

4. Collect blood samples, as an optional procedure, to cryopreserve plasma and peripheral blood mononuclear cells for examination of immune function.

Study Status Information



Study Activation / Registration Date:	11/07/2006

IRB Review and Approval Date:	05/05/2005

Study Type:	Behavioral

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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.

Links

Registration Number: NCT00507923
Study Information on Clinical Trials Registry (clinicaltrials.gov)