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CompletedNCT00165282Updated Nov 28, 2013

Mindfulness Meditation in Bone Marrow Transplantation

A Phase 2/3 interventional study of Mindfulness training and Nurse education in Hematologic Malignancy, Bone Marrow Transplantation and Stem Cell Transplantation, sponsored by Emory University. Completed at 3 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2013-11-28.

Sponsored by Emory University · Phase 2/3 and Interventional

Phase
Phase 2/3
Study type
Interventional
Enrollment
241
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Hematologic Malignancy
  • Bone Marrow Transplantation
  • Stem Cell Transplantation

Keywords

  • Meditation
  • Mindfulness meditation
  • Bone Marrow Transplant
  • Stem Cell Transplant
03

In context

Hematologic Neoplasms

1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.

This study's enrollment of 241 is above the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.

Browse Hematologic Neoplasms studies →

Lead sponsor

Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.

Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 2 / Phase 3
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
241 participants (actual)

Study arms

  • No intervention
    Usual Care

    Normal standard of care

  • Active comparator
    Nurse education

    Meets with oncology nurse

    Behavioral: Nurse education

  • Experimental
    Mindfulness training

    Taught Mindfulness meditation

    Behavioral: Mindfulness training

Interventions

  • BehavioralMindfulness training

    Taught mindfulness meditation by mindfulness instructor (trained health care professional/RN) and audio c/d

  • BehavioralNurse education

    Meets with oncology nurse to have questions answered about medical treatments and side effects

06

What researchers measure

Primary outcomes

  1. Psychological functioning

    Time frame: 1 year

Secondary outcomes

  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

07

Study locations

3 sites
  • Emory University
    Atlanta, Georgia, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
  • University of Massachusetts Medical School
    Worcester, Massachusetts 01655, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00165282
Lead sponsor
Emory University
Collaborators
Dana-Farber Cancer Institute, University of Massachusetts, Worcester
Responsible party
Susan Bauer-Wu, PhD, RN, FAAN (Professor, University of Virginia) — Principal investigator
First posted
Sep 14, 2005
Start date
Apr 2005
Primary completion
Jan 2010
Completion
Jun 2011
Last update
Nov 28, 2013

Study contacts

Susan Bauer-Wu, PhD
principal investigator · Emory University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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