Chemotherapy and Mindfulness Relaxation: A Randomized Trial at M.D. Anderson Cancer Center and M.D. Anderson Community Clinical Oncology Program
- Compare the effect of mindfulness relaxation vs relaxing music vs standard symptom
management education on conditioned and nonconditioned nausea and vomiting in patients
with newly diagnosed solid tumors undergoing chemotherapy.
- Compare mental health (anxiety, depression, and distress), quality of life
(cancer-related symptoms, fatigue, sleep, and pain), and immune function in patients
receiving these interventions.
OUTLINE: This is a multicenter study comprising a pilot phase followed by a randomized
phase. (Pilot phase completed as of 3/10/2012.)
- Pilot phase: Patients undergo mindfulness relaxation (MR) therapy comprising listening
to instructions on breathing techniques and other mind and body relaxation practices on
compact disc for 30 minutes before and during each chemotherapy session AND at least
once daily for the entire duration of chemotherapy treatment. (Pilot phase completed as
- Randomized phase: Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients undergo MR therapy as in the pilot phase.
- Arm II: Patients listen to relaxing music (with no instructions on relaxation
techniques) for 30 minutes before and during each chemotherapy session AND at
least once daily for the entire duration of chemotherapy treatment.
- Arm III: Patients receive standard symptom management education. In both phases,
nausea and vomiting, mental health (anxiety, depression, and distress), and
quality of life (cancer-related symptoms, fatigue, sleep, and pain) are assessed
at baseline, periodically during treatment, and then at 3 months.
Patients are followed annually for up to 5 years for survival.
PROJECTED ACCRUAL: A total of 474 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Conditioned nausea and vomiting as measured by Morrow assessment of nausea and emesis (MANE)
Number of incidents conditioned nausea and vomiting as measured by MANE at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment
Up to 12 months post treatment
Jon Hunter, MD, FRCP
Mount Sinai Hospital, Toronto
United States: Institutional Review Board
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - Kalamazoo||Kalamazoo, Michigan 49007-3731|
|CCOP - Michigan Cancer Research Consortium||Ann Arbor, Michigan 48106|
|CCOP - Greenville||Greenville, South Carolina 29615|
|CCOP - Grand Rapids||Grand Rapids, Michigan 49503|
|CCOP - Scott and White Hospital||Temple, Texas 76508|
|CCOP - Marshfield Clinic Research Foundation||Marshfield, Wisconsin 54449|
|CCOP - Main Line Health||Wynnewood, Pennsylvania 19096|
|University of Texas M.D. Anderson CCOP Research Base||Houston, Texas 77030-4009|