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Mindfulness Meditation in Bone Marrow Transplantation

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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

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 14, 2005
Last Update Posted Date November 28, 2013
Study Start Date  ICMJE April 2005
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2010)
Psychological functioning [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
To evaluate the effects in a mindfulness meditation group as compared to an attention group and a usual care group, on perceived stress and distress and overall quality of life.
Change History Complete list of historical versions of study NCT00165282 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2010)
  • Number of days to bone marrow engraftment [ Time Frame: 1 year ]
  • Medication use [ Time Frame: 1 year ]
  • Urinary stress hormones (cortisol and catecholamines) [ Time Frame: 1 year ]
  • Transplant related complications [ Time Frame: 1 year ]
  • Hospital length of stay and re-hospitalizations [ Time Frame: 1 year ]
  • Physical symptoms [ Time Frame: 1 year ]
  • Quality of life [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mindfulness Meditation in Bone Marrow Transplantation
Official Title  ICMJE Mindfulness Meditation in Bone Marrow Transplantation
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Hematologic Malignancy
  • Bone Marrow Transplantation
  • Stem Cell Transplantation
Intervention  ICMJE
  • Behavioral: Mindfulness training
    Taught mindfulness meditation by mindfulness instructor (trained health care professional/RN) and audio c/d
  • Behavioral: Nurse education
    Meets with oncology nurse to have questions answered about medical treatments and side effects
Study Arms  ICMJE
  • No Intervention: Usual Care
    Normal standard of care
  • Active Comparator: Nurse education
    Meets with oncology nurse
    Intervention: Behavioral: Nurse education
  • Experimental: Mindfulness training
    Taught Mindfulness meditation
    Intervention: Behavioral: Mindfulness training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 5, 2010)
241
Original Enrollment  ICMJE
 (submitted: September 9, 2005)
280
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00165282
Other Study ID Numbers  ICMJE IRB00005285
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Susan Bauer-Wu, PhD, RN, FAAN, University of Virginia
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE
  • Dana-Farber Cancer Institute
  • University of Massachusetts, Worcester
Investigators  ICMJE
Principal Investigator: Susan Bauer-Wu, PhD Emory University
PRS Account Emory University
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP