• Conditioned nausea and vomiting as measured by Morrow assessment of nausea and emesis (MANE) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment [ Designated as safety issue: No ]
  
• Distress as measured by Impact of Event Scale (IES) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment [ Designated as safety issue: No ]
  
• Fatigue as measured by brief fatigue inventory (BFI) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment [ Designated as safety issue: No ]
  
• Anxiety as measured by Spielberger State/Trait Anxiety Scale (STAI) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment [ Designated as safety issue: No ]
  
• Depression as measured by Center for Epidemiology-Depression (CES-D) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment [ Designated as safety issue: No ]
  
• Sleep as measured by Pittsburgh Sleep Quality Index (PSQI) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment [ Designated as safety issue: No ]
  
• Pain as measured by brief pain inventory (BPI) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment [ Designated as safety issue: No ]
  
• Quality of life as measured by Functional Assessment of Cancer Therapy at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment [ Designated as safety issue: No ]
  

• Immune suppression as measured by cytotoxicity, stimulated release of IL-12, -4, -10, intracellular cytokines and lymphocyte phenotype at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment [ Designated as safety issue: Yes ]
  

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: 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.

• 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 400 patients (25 for the pilot phase and 375 for the randomized phase [125 per treatment arm]) will be accrued for this study.