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Meditation and Cognitive Function in Women With Breast Cancer

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tibetan Meditation Program
No Meditation
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer, Tibetan Meditation, Quality of Life, Cognitive Function, QOL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Tibetan Meditation

No Meditation

Arm Description

Outcomes

Primary Outcome Measures

Number of Eligible Women Approached Who Consented to be in Trial (Feasibility)
Women's Reported Satisfaction with Tibetan Meditation intervention

Secondary Outcome Measures

Full Information

First Posted
November 7, 2007
Last Updated
August 26, 2022
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00556218
Brief Title
Meditation and Cognitive Function in Women With Breast Cancer
Official Title
Feasibility Study of Meditation, Cognitive Function, and Quality of Life in Women With Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 24, 2007 (Actual)
Primary Completion Date
August 10, 2022 (Actual)
Study Completion Date
August 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Screening Tests: During the "screening" visit, you will be asked 4 questions about your memory and concentration abilities. Based on how you score on this screening questionnaire, you may not be eligible to participate in the study even if you have already signed the informed consent form. If you are found to be eligible for the study based on the screening questionnaire, you will complete some tests during the screening visit to check your memory and concentration. For example, you will be asked to remember a list of words and then be asked to recall them later. You will also complete questionnaires asking about your mood, quality of life, and other things like sleep, nervousness, and your experience with cancer. All together, the tests and questionnaires should take about 90 minutes to complete. Study Groups: You will be randomly assigned (as in the toss of a coin) to 1 of 2 groups. People in Group 1 will take part in a Tibetan meditation program. People in Group 2 will be placed on a waiting list. They may participate in the meditation program 3 months after being enrolled in the study (when Group 1 has finished the follow-up visit). Meditation Sessions: If you are Group 1, you have 12 sessions of Tibetan meditation (2 times a week), over a 6-week period. You will be asked to complete a form asking about your satisfaction with the program at the start of each week. The form will take 1-2 minutes to complete. The meditation sessions will take place at M. D. Anderson. During the meditation sessions, you will do deep breathing and visualization exercises and produce some sounds like "Ah." Each session will last about 60 minutes. One (1) or more of these meditation sessions may be videotaped by the study staff for check the quality of the sessions. Only the study staff will be able to view this videotape. All videos will be destroyed after the data is collected. Participants in both groups will be mailed a questionnaire packet to fill out and send back (return postage will be included in the packets) at 1 month and then at the end of the meditation sessions (2 months). The questionnaires will ask about your mood, quality of life, and other things like sleeping habits and nervousness. The packet will take about 45 minutes to fill out. If you are in Group 2, you will receive packets at about the same time. Your responses on these questionnaires will not be shared with your doctor. If you feel you need a doctor's opinion about anything that is asked in these questionnaires (for example, if you feel depressed or distressed), please contact your doctor. Follow-up Visit: One (1) month after the last meditation session (or at a similar time, for participants in Group 2), you will be asked to return to the clinic. You will take some tests to check your memory and concentration, similar to the tests you took at your screening visit. You will complete questionnaires asking about your mood, quality of life, and other things like sleep, nervousness, and your experience with cancer. All together, the questionnaires and tests should take about 90 minutes to complete. Once the follow-up visit is complete, the study is over. After Group 1 has completed the follow-up visit, Group 2 will be given the option to take the meditation classes. This is an investigational study. Up to 60 participants will be enrolled in this study. All will be enrolled at M. D. Anderson.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Tibetan Meditation, Quality of Life, Cognitive Function, QOL

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tibetan Meditation
Arm Type
Other
Arm Title
No Meditation
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Tibetan Meditation Program
Intervention Description
12 sessions of Tibetan meditation (2 times a week), over a 6-week period. Each class will last about 60 minutes.
Intervention Type
Behavioral
Intervention Name(s)
No Meditation
Intervention Description
No meditation; usual care.
Primary Outcome Measure Information:
Title
Number of Eligible Women Approached Who Consented to be in Trial (Feasibility)
Time Frame
2 Years
Title
Women's Reported Satisfaction with Tibetan Meditation intervention
Time Frame
2 Years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with stage I - III breast cancer who have undergone chemotherapy (either neoadjuvant or adjuvant) 6 - 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorenzo Cohen, PhD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

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Meditation and Cognitive Function in Women With Breast Cancer

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