Mindfulness Relaxation Compared With Relaxing Music and Standard Symptom Management Education in Treating Patients Who Are Undergoing Chemotherapy For Newly Diagnosed Solid Tumors
NCT ID: NCT00086762
Last Updated: 2022-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
474 participants
INTERVENTIONAL
2004-06-30
2022-08-11
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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MR Therapy
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
Questionnaire completion at baseline, during the middle of chemotherapy treatment, and at chemotherapy completion.
Relaxing Music (RM) Therapy
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
Questionnaire completion at baseline, during the middle of chemotherapy treatment, and at chemotherapy completion.
Standard Symptom Management
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
Questionnaire completion at baseline, during the middle of chemotherapy treatment, and at chemotherapy completion.
Interventions
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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.
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
Standard Symptom Management
Participants receive standard symptom management education. General information received about how to manage symptoms that develop due to the chemotherapy.
Questionnaires
Questionnaire completion at baseline, during the middle of chemotherapy treatment, and at chemotherapy completion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. will undergo an undefined number of chemotherapy regimens
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jon Hunter, MD, FRCP
Role: PRINCIPAL_INVESTIGATOR
Mount Sinai Hospital, Canada
Lorenzo Cohen, PHD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
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CCOP - Wichita
Wichita, Kansas, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
CCOP - Main Line Health
Wynnewood, Pennsylvania, United States
CCOP - Greenville
Greenville, South Carolina, United States
University of Texas M.D. Anderson CCOP Research Base
Houston, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
Countries
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Other Identifiers
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MDA-CCC-0106
Identifier Type: -
Identifier Source: secondary_id
CDR0000357213
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-00860
Identifier Type: REGISTRY
Identifier Source: secondary_id
2004-0024
Identifier Type: -
Identifier Source: org_study_id
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