CLINICAL TRIAL SUMMARY

MDACC Study No:2004-0024 (clinicaltrials.gov NCT No: NCT00086762)
Title:Chemotherapy and Mindfulness Relaxation: A Randomized Trial at M.D. Anderson Cancer Center and M.D. Anderson Community Clinical Oncology Program
Principal Investigator:Lorenzo Cohen
Treatment Agent:None
Study Status:Closed
Study Description:The goal of this research study is to see if there are techniques available to
treat and/or prevent the feelings of nausea and vomiting that can occur when
you receive chemotherapy. Researchers will study if a technique called
Mindfulness Relaxation has any effect on your feelings of anxiety, depression
(sadness), distress, your cancer related symptoms of fatigue (tiredness),
sleep, pain, and your immune function (how well your body can fight infection).

Mindfulness relaxation is a technique to help you quiet the thoughts in your
mind, and relax your body before and during chemotherapy.

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Disease Group:Breast; Gastrointestinal; Gynecology; Prostate
Phase of Study:Phase II
Treatment Agents:None
Treatment Location:MDACC + Community Programs (CCOP/Network)
Estimated Length of Stay in Houston:No hospitalization is required for this study.
Supported By:N/A
Return Visit:Participants will have 4 study related visits during the course of this trial.
These will be at baseline, in the middle of their course of therapy, at the end
of treatment, and at approximately 3 months (90-120 days) post treatment.
Home Care:Patients will be asked to fill out a diary for a total of 7 days for each chemo
session. Patients will write in their diary 3 days before their chemo session,
on the day of their chemo session, and for 3 days after each chemo session.


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Physician Name:Lorenzo Cohen
Dept:Behavioral Science
For Clinical Trial Enrollment:713-792-0919
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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