Trial Information

Chemotherapy and Mindfulness Relaxation: A Randomized Trial at M.D. Anderson Cancer Center and M.D. Anderson Community Clinical Oncology Program

OBJECTIVES:

Primary

- 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.

Secondary

- 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
of 3/10/2012.)

- 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.