Meditation and Cognitive Function in Women With Breast Cancer - Full Text View

Purpose

Primary Objectives:

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

Condition	Intervention
Breast Cancer	Behavioral: Tibetan Meditation Program Behavioral: No meditation

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Uncontrolled, Parallel Assignment

Official Title:	Feasibility Study of Meditation, Cognitive Function, and Quality of Life in Women With Breast Cancer

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

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. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Whether the meditation program helps to improve brain function and sleep quality will also be studied. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Estimated Enrollment:	46
Study Start Date:	October 2007
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Tibetan Meditation	Behavioral: Tibetan Meditation Program 12 sessions of Tibetan meditation (2 times a week), over a 6-week period. Each class will last about 60 minutes.
2 No meditation	Behavioral: No meditation No meditation; usual care.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women with stage I - III breast cancer who have undergone chemotherapy (either neoadjuvant or adjuvant) 12 - 60 months prior to recruitment.
Women who report cognitive impairment since starting chemotherapy as assessed by four questions from the FACT-Cog.
Women must be 18 years or older.
Women must be able to read, write and speak English.
Women must be currently undergoing hormone therapy (e.g., Tamoxifen or AIs)
Willing to come to MDACC for the meditation sessions and assessment sessions.
Women must be within 2 hours driving distance of MDACC.

Exclusion Criteria:

Women who have a documented diagnosis of a formal thought disorder (e.g., schizophrenia) will be excluded from the study.
Women with metastatic disease to the brain or any past neurologic injury.
Women with a Mini-Mental State Examination score of 23 or below.
Women with recurrent cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556218

Contacts


Contact: Lorenzo Cohen, PhD	713-745-4260

Locations


United States, Texas
	U.T.M.D. Anderson Cancer Center	Recruiting
	Houston, Texas, United States, 77030
	Principal Investigator: Lorenzo Cohen, PhD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators


Principal Investigator:	Lorenzo Cohen, PhD	U.T.M.D. Anderson Cancer Center

More Information

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Lorenzo Cohen, PhD/Professor )
Study ID Numbers:	2007-0311
First Received:	November 7, 2007
Last Updated:	May 2, 2008
ClinicalTrials.gov Identifier:	NCT00556218
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Breast Cancer

Tibetan Meditation

Quality of Life

Cognitive Function

QOL

Study placed in the following topic categories:

Skin Diseases

Quality of Life

Breast Neoplasms

Breast Diseases

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on September 22, 2008

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00556218