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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedBiomarker/Laboratory analysis, Educational/Counseling/Training, Supportive careClosed18 and overNCI, Other2004-0024
MDA-CCC-0106, CDR0000357213, NCI-2009-00860, NCT00086762

Trial Description

Summary

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: This randomized clinical trial is studying mindfulness relaxation to see how well it works compared to relaxing music or standard symptom management education in treating patients who are receiving chemotherapy for newly diagnosed solid tumors.

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

M. D. Anderson Cancer Center at University of Texas

  • National Cancer Institute
Jon Hunter, MD, FRCP, Principal Investigator
Lorenzo Cohen, Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00086762
ClinicalTrials.gov processed this data on May 04, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.