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Meditation and Cognitive Function in Women With Breast Cancer
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, September 2009
First Received: November 7, 2007   Last Updated: September 28, 2009   History of Changes
Sponsor: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00556218
  Purpose

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.


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

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Eligible Women Approached Who Consented to be in Trial (Feasibility) [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  • Women's Reported Satisfaction with Tibetan Meditation intervention [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2007
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
No Meditation Behavioral: No Meditation
No meditation; usual care.

  Show Detailed Description

  Eligibility

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

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
  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

Additional Information:
No publications provided

Responsible Party: U.T.M.D. Anderson Cancer Center ( Lorenzo Cohen, PhD/Professor )
Study ID Numbers: 2007-0311
Study First Received: November 7, 2007
Last Updated: September 28, 2009
ClinicalTrials.gov Identifier: NCT00556218     History of Changes
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

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010