Mindfulness Meditation in Bone Marrow Transplantation

November 26, 2013 updated by: Susan Bauer-Wu, PhD, RN, FAAN, Emory University
The main purpose of this study is to examine techniques to help patients cope better with the stem cell/bone marrow transplant procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

241

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States
        • Emory University
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Psychological functioning
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 1 year
1 year
Number of days to bone marrow engraftment
Time Frame: 1 year
1 year
Medication use
Time Frame: 1 year
1 year
Urinary stress hormones (cortisol and catecholamines)
Time Frame: 1 year
1 year
Transplant related complications
Time Frame: 1 year
1 year
Hospital length of stay and re-hospitalizations
Time Frame: 1 year
1 year
Physical symptoms
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

Dana-Farber Cancer Institute
University of Massachusetts, Worcester

Investigators

  • Principal Investigator: Susan Bauer-Wu, PhD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

November 28, 2013

Last Update Submitted That Met QC Criteria

November 26, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00005285

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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