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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00086762 |
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.
Condition | Intervention |
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Cancer-Related Problem/Condition Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific |
Procedure: mind-body intervention procedure Procedure: nausea and vomiting therapy Procedure: quality-of-life assessment |
Study Type: | Interventional |
Study Design: | Randomized, Active Control |
Official Title: | Chemotherapy and Mindfulness Relaxation: A Randomized Trial at M.D. Anderson Cancer Center and M.D. Anderson Community Clinical Oncology Program |
Estimated Enrollment: | 400 |
Study Start Date: | June 2004 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study comprising a pilot phase followed by a randomized phase.
Randomized phase: Patients are randomized to 1 of 3 treatment arms.
Patients are followed annually for up to 5 years for survival.
PROJECTED ACCRUAL: A total of 400 patients (25 for the pilot phase and 375 for the randomized phase [125 per treatment arm]) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Kansas | |
CCOP - Wichita | Recruiting |
Wichita, Kansas, United States, 67214-3882 | |
Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
United States, Michigan | |
CCOP - Grand Rapids | Recruiting |
Grand Rapids, Michigan, United States, 49503 | |
Contact: Marianne K. Lange, MD 616-391-1230 marianne.lange@grcop.org | |
CCOP - Kalamazoo | Recruiting |
Kalamazoo, Michigan, United States, 49007-3731 | |
Contact: Raymond S. Lord, MD 269-373-7458 rlord@wmcc.org | |
CCOP - Michigan Cancer Research Consortium | Recruiting |
Ann Arbor, Michigan, United States, 48106 | |
Contact: Philip J. Stella, MD 734-434-4930 | |
United States, Pennsylvania | |
CCOP - Main Line Health | Recruiting |
Wynnewood, Pennsylvania, United States, 19096 | |
Contact: Paul B. Gilman, MD 610-645-2057 | |
United States, South Carolina | |
CCOP - Greenville | Recruiting |
Greenville, South Carolina, United States, 29615 | |
Contact: Jeffrey K. Giguere, MD, FACP 864-241-6251 | |
United States, Texas | |
CCOP - Scott and White Hospital | Recruiting |
Temple, Texas, United States, 76508 | |
Contact: Lucas Wong, MD 254-724-1053 lwong@swmail.sw.org | |
University of Texas M.D. Anderson CCOP Research Base | Recruiting |
Houston, Texas, United States, 77030-4009 | |
Contact: Marlys Harden-Harrison, RN 713-563-0276 | |
United States, Wisconsin | |
CCOP - Marshfield Clinic Research Foundation | Recruiting |
Marshfield, Wisconsin, United States, 54449 | |
Contact: Clinical Trials Office - CCOP - Marshfield Clinic Research Fou 715-389-4457 |
Principal Investigator: | Jon Hunter, MD, FRCP | Mount Sinai Hospital - Toronto |
Study ID Numbers: | CDR0000357213, MDA-CCC-0106, MDA-2004-0024 |
Study First Received: | July 8, 2004 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00086762 |
Health Authority: | Unspecified |
nausea and vomiting quality of life unspecified adult solid tumor, protocol specific |
Signs and Symptoms Vomiting Signs and Symptoms, Digestive Quality of Life Nausea |