Completed

Chemotherapy and Mindfulness Relaxation: A Randomized Trial at M.D. Anderson Cancer Center and M.D. Anderson Community Clinical Oncology Program

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What is being tested

MR Therapy

+ Questionnaires

+ Relaxing Music (RM) Therapy

Behavioral
Who is being recruted

Digestive System Diseases+8

+ Digestive System Neoplasms

+ Disease

Over 18 Years
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: June 2004
See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleChemotherapy and Mindfulness Relaxation: A Randomized Trial at M.D. Anderson Cancer Center and M.D. Anderson Community Clinical Oncology Program 
NCT00086762
Principal SponsorM.D. Anderson Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

474 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsDiseaseGastrointestinal DiseasesGastrointestinal NeoplasmsNauseaNeoplasmsNeoplasms by SitePathologic ProcessesSigns and Symptoms, DigestiveVomiting

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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.

Group III

Active Comparator
Arm III: Participants receive standard symptom management education.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

Suspended

CCOP - Wichita

Wichita, United StatesSee the location
Suspended

CCOP - Michigan Cancer Research Consortium

Ann Arbor, United States
Suspended

CCOP - Grand Rapids

Grand Rapids, United States
Suspended

CCOP - Kalamazoo

Kalamazoo, United States
Completed9 Study Centers