Mindfulness Relaxation Compared With Relaxing Music and Standard Symptom Management Education in Treating Patients Who Are Undergoing Chemotherapy For Newly Diagnosed Solid Tumors
Chemotherapy and Mindfulness Relaxation: A Randomized Trial at M.D. Anderson Cancer Center and M.D. Anderson Community Clinical Oncology Program
4 other identifiers
interventional
474
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2004
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 8, 2004
CompletedFirst Posted
Study publicly available on registry
July 12, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 11, 2022
CompletedSeptember 1, 2022
August 1, 2022
18.2 years
July 8, 2004
August 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Conditioned nausea and vomiting as measured by Morrow assessment of nausea and emesis (MANE)
Number of incidents conditioned nausea and vomiting as measured by MANE at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment
Up to 12 months post treatment
Distress as measured by Impact of Event Scale (IES)
Distress as measured by Impact of Event Scale (IES) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment
Up to 12 months post treatment
Fatigue as measured by brief fatigue inventory (BFI)
Fatigue as measured by brief fatigue inventory (BFI) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment
Up to 12 months post treatment
Anxiety as measured by Spielberger State/Trait Anxiety Scale (STAI)
Anxiety as measured by Spielberger State/Trait Anxiety Scale (STAI) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment
Up to 12 months post treatment
Depression as measured by Center for Epidemiology-Depression (CES-D)
Depression as measured by Center for Epidemiology-Depression (CES-D) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment.
Up to 12 months post treatment
Sleep as measured by Pittsburgh Sleep Quality Index (PSQI)
Sleep as measured by Pittsburgh Sleep Quality Index (PSQI) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment
Up to 12 months post treatment
Pain as measured by brief pain inventory (BPI)
Pain as measured by brief pain inventory (BPI) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment
Up to 12 months post treatment
Quality of life as measured by Functional Assessment of Cancer Therapy
Quality of life as measured by Functional Assessment of Cancer Therapy at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment
Up to 12 months post treatment
Secondary Outcomes (1)
Immune suppression as measured by cytotoxicity, stimulated release of IL-12, -4, -10, intracellular cytokines and lymphocyte phenotype
Up to 12 months post treatment
Study Arms (3)
MR Therapy
EXPERIMENTALParticipants 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.
Relaxing Music (RM) Therapy
EXPERIMENTALArm 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.
Standard Symptom Management
ACTIVE COMPARATORArm III: Participants receive standard symptom management education.
Interventions
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.
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
Participants receive standard symptom management education. General information received about how to manage symptoms that develop due to the chemotherapy.
Questionnaire completion at baseline, during the middle of chemotherapy treatment, and at chemotherapy completion.
Eligibility Criteria
You may qualify if:
- are \>/= 18 years of age
- are anticipated to undergo at least four cycles of chemotherapy treatment
- have had no previous treatment with chemotherapy
- have no evidence of distant metastatic disease
- can read/speak in English or Spanish
- have no known psychotic diagnosis
- have an expected survival of at least 6 months
You may not qualify if:
- have a known psychotic diagnosis
- will undergo an undefined number of chemotherapy regimens
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (9)
CCOP - Wichita
Wichita, Kansas, 67214-3882, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731, United States
CCOP - Main Line Health
Wynnewood, Pennsylvania, 19096, United States
CCOP - Greenville
Greenville, South Carolina, 29615, United States
University of Texas M.D. Anderson CCOP Research Base
Houston, Texas, 77030-4009, United States
CCOP - Scott and White Hospital
Temple, Texas, 76508, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jon Hunter, MD, FRCP
Mount Sinai Hospital, Canada
- STUDY CHAIR
Lorenzo Cohen, PHD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2004
First Posted
July 12, 2004
Study Start
June 1, 2004
Primary Completion
August 11, 2022
Study Completion
August 11, 2022
Last Updated
September 1, 2022
Record last verified: 2022-08