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Mindfulness Meditation in Bone Marrow Transplantation

This study is currently recruiting participants.
Verified by Dana-Farber Cancer Institute, December 2007

Sponsors and Collaborators: Dana-Farber Cancer Institute
University of Massachusetts
Information provided by: Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00165282
  Purpose

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


Condition Intervention Phase
Hematologic Malignancy
Bone Marrow Transplantation
Stem Cell Transplantation
Behavioral: Mindfulness Meditation
Behavioral: Standard of Care
Behavioral: Nurse Education
Phase II

MedlinePlus related topics:   Bone Marrow Transplantation    Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Mindfulness Meditation in Bone Marrow Transplantation

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To evaluate the effects in a mindfulness meditation group, as compared to an attention group and a usual care group, on perceived stress, distress, and overall quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:   280
Study Start Date:   April 2005
Estimated Study Completion Date:   April 2009
Estimated Primary Completion Date:   April 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Group 1: Active Comparator
Normal standard of care
Behavioral: Standard of Care
Standard care given during BMT
Group 2: Active Comparator
Meets with oncology nurse
Behavioral: Nurse Education
Meets with oncology nurse to have questions answered about stem cell/BMT experience
Group 3: Active Comparator
Taught Mindfulness meditation
Behavioral: Mindfulness Meditation
Taught mindfulness meditation by mindfulness instructor and audio c/d

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.

  Eligibility
Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165282

Contacts
Contact: Susan Bauer-Wu, D.N.Sc.     617-632-1925     susan_bauer_wu@dfci.harvard.edu    

Locations
United States, Georgia
Emory University     Recruiting
      Atlanta, Georgia, United States
United States, Massachusetts
Dana-Farber Cancer Institute     Recruiting
      Boston, Massachusetts, United States, 02115
      Contact: Martha W. Healey, RN, FNP         mhealey1@partners.org    
University of Massachusetts Medical School     Recruiting
      Worcester, Massachusetts, United States, 01655
      Contact: James Carmody     508-856-1205        

Sponsors and Collaborators
Dana-Farber Cancer Institute
University of Massachusetts

Investigators
Principal Investigator:     Susan Bauer-Wu, D.N.Sc.     Dana-Farber Cancer Institute    
  More Information


Responsible Party:   Dana-Farber Cancer Institute ( Mary Cooley, PhD, RN )
Study ID Numbers:   05-070
First Received:   September 9, 2005
Last Updated:   December 19, 2007
ClinicalTrials.gov Identifier:   NCT00165282
Health Authority:   United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Meditation  
Mindfulness meditation  
Bone Marrow Transplant  
Stem Cell Transplant  

Study placed in the following topic categories:
Hematologic Neoplasms
Hematologic Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 24, 2008




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