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


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Number of Eligible Women Approached Who Consented to be in Trial (Feasibility)

Outcome Time Frame:

2 Years

Safety Issue:

No

Principal Investigator

Lorenzo Cohen, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2007-0311

NCT ID:

NCT00556218

Start Date:

October 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Tibetan Meditation
  • Quality of Life
  • Cognitive Function
  • QOL
  • Breast Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030