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Mindfulness Relaxation Compared With Relaxing Music and Standard Symptom Management Education in Treating Patients Who Are Undergoing Chemotherapy For Newly Diagnosed Solid Tumors

NCT00086762 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 474

Last updated 2022-09-01

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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

BEHAVIORAL

Standard Symptom Management

Participants receive standard symptom management education. General information received about how to manage symptoms that develop due to the chemotherapy.

BEHAVIORAL

Questionnaires

Questionnaire completion at baseline, during the middle of chemotherapy treatment, and at chemotherapy completion.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Jon Hunter, MD, FRCP · Mount Sinai Hospital, Canada

  • Lorenzo Cohen, PHD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2022-08-11
Completion
2022-08-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00086762 on ClinicalTrials.gov