Mindfulness Relaxation Compared With Relaxing Music and Standard Symptom Management Education in Treating Patients Who Are Undergoing Chemotherapy For Newly Diagnosed Solid Tumors

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.

Inclusion Criteria:

1. are >/= 18 years of age

2. are anticipated to undergo at least four cycles of chemotherapy treatment

3. have had no previous treatment with chemotherapy

4. have no evidence of distant metastatic disease

5. can read/speak in English or Spanish

6. have no known psychotic diagnosis

7. have an expected survival of at least 6 months

Exclusion Criteria:

1. have a known psychotic diagnosis

2. will undergo an undefined number of chemotherapy regimens