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Meditation and Cognitive Function in Women With Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00556218
First received: November 7, 2007
Last updated: September 26, 2012
Last verified: September 2012
History of Changes
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Feasibility Study of Meditation, Cognitive Function, and Quality of Life in Women With Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

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 2014 (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

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Lorenzo Cohen, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
UT MD Anderson Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00556218     History of Changes
Other Study ID Numbers: 2007-0311
Study First Received: November 7, 2007
Last Updated: September 26, 2012
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:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013