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Mindfulness Meditation in Bone Marrow Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00165282
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : November 28, 2013
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Susan Bauer-Wu, PhD, RN, FAAN, University of Virginia

Study Description
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Brief Summary:
The main purpose of this study is to examine techniques to help patients cope better with the stem cell/bone marrow transplant procedure.

Condition or disease Intervention/treatment Phase
Hematologic Malignancy Bone Marrow Transplantation Stem Cell Transplantation Behavioral: Mindfulness training Behavioral: Nurse education Phase 2 Phase 3

Detailed Description:

Patients will be assigned to one of three study groups:

  1. receives the normal standard care;
  2. meets with an oncology nurse educator, in addition to the regular nurses on the transplant team. The nurse educator will provide information and answers to patient's questions about the stem cell/bone marrow transplant experience; or
  3. is taught mindfulness meditation by a nurse who is trained to be a mindfulness instructor and by an audio CD.

Mindfulness meditation is a technique that may help in coping with the stress and difficulties associated with cancer and undergoing a stem cell/bone marrow transplant. It involves learning to be in the present moment by paying attention to your breathing, sights, and sounds, and to sensations you may be experiencing, or thoughts and feelings you may be having.

Mindfulness meditation has been shown to be helpful to patients in the clinic who have cancer and other medical conditions.

Patients, regardless of random group assignment, will complete a questionnaire 8 different times, from before they are admitted to the hospital until 6 months after discharge.

Patients will also provide two urine samples while in the hospital to measure the levels of stress hormones present in the urine.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Mindfulness Meditation in Bone Marrow Transplantation
Study Start Date : April 2005
Actual Primary Completion Date : January 2010
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Usual Care
Normal standard of care
Active Comparator: Nurse education
Meets with oncology nurse
 Behavioral: Nurse education
Meets with oncology nurse to have questions answered about medical treatments and side effects
Experimental: Mindfulness training
Taught Mindfulness meditation
 Behavioral: Mindfulness training
Taught mindfulness meditation by mindfulness instructor (trained health care professional/RN) and audio c/d


Outcome Measures
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Primary Outcome Measures :
  1. Psychological functioning [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Number of days to bone marrow engraftment [ Time Frame: 1 year ]
  2. Medication use [ Time Frame: 1 year ]
  3. Urinary stress hormones (cortisol and catecholamines) [ Time Frame: 1 year ]
  4. Transplant related complications [ Time Frame: 1 year ]
  5. Hospital length of stay and re-hospitalizations [ Time Frame: 1 year ]
  6. Physical symptoms [ Time Frame: 1 year ]
  7. Quality of life [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Autologous stem cell transplantation for hematologic malignancy
  • First transplant
  • 21 years of age or older
  • Speaks and understands English

Exclusion Criteria:

  • Planned tandem (more than one) transplant
  • Taking corticosteroids on a regular basis for a chronic condition
  • Prior formal mindfulness meditation training
  • Significant cognitive impairment and/or confirmed psychosis or thought disorder
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165282


Locations
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United States, Georgia
Emory University
Atlanta, Georgia, United States
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
Emory University
Dana-Farber Cancer Institute
University of Massachusetts, Worcester
Investigators
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Principal Investigator: Susan Bauer-Wu, PhD Emory University
More Information
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Responsible Party: Susan Bauer-Wu, PhD, RN, FAAN, Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT00165282    
Other Study ID Numbers: IRB00005285
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: November 28, 2013
Last Verified: November 2013
Keywords provided by Susan Bauer-Wu, PhD, RN, FAAN, University of Virginia:
Meditation
Mindfulness meditation
Bone Marrow Transplant
Stem Cell Transplant
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases