Overview

This trial is active, not recruiting.

Conditions chemotherapy-induced nausea and vomiting, unspecified adult solid tumor, protocol specific, breast cancer, gastrointestinal cancer, disease (or disorder); gynecological, prostate cancer
Treatments mr therapy, relaxing music (rm) therapy, standard symptom management, questionnaires
Sponsor M.D. Anderson Cancer Center
Collaborator National Cancer Institute (NCI)
Start date June 2004
End date June 2016
Trial size 474 participants
Trial identifier NCT00086762, 2004-0024, CDR0000357213, MDA-CCC-0106, NCI-2009-00860

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Arm
(Experimental)
Participants receive Mindfulness Relaxation (MR) therapy as in the pilot phase. A CD with the mindfulness relaxation technique recorded on it will be given to participant. Participant to listen to the recording for about 30 minutes before receiving chemotherapy and during the time they are receiving chemotherapy. In addition to the mindfulness relaxation technique, they will also receive general information about how to manage symptoms that develop due to the chemotherapy they are receiving.
mr therapy
Arm I: Participants receive Mindfulness Relaxation (MR) therapy as in the pilot phase. Instructions given on breathing techniques and other practices to help relax mind and body.
questionnaires surveys
Questionnaire completion at baseline, during the middle of chemotherapy treatment, and at chemotherapy completion.
(Experimental)
Arm II: Participants 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.
relaxing music (rm) therapy
Participants 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
questionnaires surveys
Questionnaire completion at baseline, during the middle of chemotherapy treatment, and at chemotherapy completion.
(Active Comparator)
Arm III: Participants receive standard symptom management education.
standard symptom management
Participants receive standard symptom management education. General information received about how to manage symptoms that develop due to the chemotherapy.
questionnaires surveys
Questionnaire completion at baseline, during the middle of chemotherapy treatment, and at chemotherapy completion.

Primary Outcomes

Measure
Conditioned nausea and vomiting as measured by Morrow assessment of nausea and emesis (MANE)
time frame: Up to 12 months post treatment
Distress as measured by Impact of Event Scale (IES)
time frame: Up to 12 months post treatment
Fatigue as measured by brief fatigue inventory (BFI)
time frame: Up to 12 months post treatment
Anxiety as measured by Spielberger State/Trait Anxiety Scale (STAI)
time frame: Up to 12 months post treatment
Depression as measured by Center for Epidemiology-Depression (CES-D)
time frame: Up to 12 months post treatment
Sleep as measured by Pittsburgh Sleep Quality Index (PSQI)
time frame: Up to 12 months post treatment
Pain as measured by brief pain inventory (BPI)
time frame: Up to 12 months post treatment
Quality of life as measured by Functional Assessment of Cancer Therapy
time frame: Up to 12 months post treatment

Secondary Outcomes

Measure
Immune suppression as measured by cytotoxicity, stimulated release of IL-12, -4, -10, intracellular cytokines and lymphocyte phenotype
time frame: Up to 12 months post treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Chemotherapy and Mindfulness Relaxation: A Randomized Trial at M.D. Anderson Cancer Center and M.D. Anderson Community Clinical Oncology Program
Principal investigator Jon Hunter, MD, FRCP
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.