Clinical Trials Directory

Trials / Completed

CompletedNCT00086762

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
474 (estimated)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMR TherapyArm 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.
BEHAVIORALRelaxing Music (RM) TherapyParticipants 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
BEHAVIORALStandard Symptom ManagementParticipants receive standard symptom management education. General information received about how to manage symptoms that develop due to the chemotherapy.
BEHAVIORALQuestionnairesQuestionnaire completion at baseline, during the middle of chemotherapy treatment, and at chemotherapy completion.

Timeline

Start date
2004-06-01
Primary completion
2022-08-11
Completion
2022-08-11
First posted
2004-07-12
Last updated
2022-09-01

Locations

9 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00086762. Inclusion in this directory is not an endorsement.