RATIONALE: Mindfulness relaxation, a technique to help patients quiet their thoughts and relax their bodies before and during chemotherapy, may reduce or prevent nausea and vomiting. It may also help improve mental health, quality of life, and immune function in patients receiving chemotherapy.

PURPOSE: Randomized clinical trial to compare the effectiveness of mindfulness relaxation with that of relaxing music and standard symptom management education in treating patients who are receiving chemotherapy for newly diagnosed solid tumors.

Condition	Treatment or Intervention
nausea and vomiting Quality of Life unspecified adult solid tumor, protocol specific	Procedure: cancer prevention intervention  Procedure: complementary and alternative therapy  Procedure: mind-body interventions  Procedure: nausea and vomiting therapy  Procedure: quality-of-life assessment  Procedure: supportive care/therapy

Further Study Details: 

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 treatments.

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 tape or compact disc for 30 minutes before and during each chemotherapy session AND at least once daily for the entire duration of chemotherapy treatment.
• 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, in the middle of chemotherapy (course 2 of a 4-course chemotherapy protocol OR course 3 of a 6-course chemotherapy protocol), at the end of treatment, and then at 3 months.

Patients are followed 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Newly diagnosed malignant solid tumor
• Undergoing at least 4 courses of chemotherapy
• No evidence of metastatic disease

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• Not specified

Life expectancy

• At least 6 months

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Able to read and speak English
• No known psychotic diagnosis

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Texas
      University of Texas M.D. Anderson CCOP Research Base, Houston,  Texas,  77030-4009,  United States; Recruiting

Study chairs or principal investigators

Jon Hunter, MD, FRCP,  Principal Investigator,  Mount Sinai Hospital - Toronto   

Study ID Numbers:  CDR0000357213; MDA-CCC-0106; MDA-2004-0024; NCT00086762
Record last reviewed:  June 2004
Last Updated:  December 6, 2004
Record first received:  July 8, 2004
ClinicalTrials.gov Identifier:  NCT00086762
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08