MDACC Study Summary 2007-0311

Study Summary
No. 2007-0311:.......Breast......Lorenzo Cohen......Behavioral Science

Study Summary Title



Study Summary Number:	2007-0311

Study Title:	Feasibility Study of Meditation, Cognitive Function, and Quality of Life in Women with Breast 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:	3 times a week for 8 weeks

Treatment Agents:	Meditation	Home Care:	NA

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	NA


Description/ Intervention:	The goal of this behavioral research study is to learn if participating in a Tibetan meditation program helps to improve quality of life for women after chemotherapy and during recovery from breast cancer. Whether the meditation program helps to improve brain function and sleep quality will also be studied.

Study Objectives / Outcomes

1. Pilot-test a Tibetan Meditation program to determine the acceptability and feasibility of teaching meditation to women who have undergone chemotherapy treatment for breast cancer. This will be accomplished by evaluating interest during the recruitment period, study attrition, satisfaction, meditation session attendance, and frequency of practicing meditation outside the hospital; and completion of questionnaires.

2. Examine the effects of meditation after chemotherapy for breast cancer on cognitive function.

3. Examine the effects of meditation after chemotherapy for breast cancer on secondary end points including fatigue, QOL, mental health, and sleep disturbances.

Study Status Information



Study Activation / Registration Date:	10/24/2007

IRB Review and Approval Date:	09/11/2007

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 have undergone chemotherapy (either neoadjuvant or adjuvant) 6 - 60 months prior to recruitment.

2) Women who report cognitive impairment since starting chemotherapy as assessed by four questions from the FACT-Cog.

3) Women must be 18 years or older.

4) Women must be able to read, write and speak English.

5) Women must be currently undergoing hormone therapy (e.g., Tamoxifen or AIs)

6) Willing to come to MDACC for the meditation sessions and assessment sessions.

7) Women must be within 2 hours driving distance of MDACC.

Exclusion Criteria:

1) Women who have a documented diagnosis of a formal thought disorder (e.g., schizophrenia) will be excluded from the study.

2) Women with metastatic disease to the brain or any past neurologic injury.

3) Women with a Mini-Mental State Examination score of 23 or below.

4) Women with recurrent cancer

Links

Registration Number: NCT00556218
Study Information on Clinical Trials Registry (clinicaltrials.gov)