Mindfulness Meditation in Bone Marrow Transplantation

Phase 2

Completed

• Conditions: Hematologic Malignancy; Bone Marrow Transplantation; Stem Cell Transplantation
• Interventions: Behavioral: Nurse education; Behavioral: Mindfulness training

• Registration Number: NCT00165282
• Lead Sponsor: Emory University

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 Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-14
• Primary Completion: 2010-01
• Study Completion: 2011-06
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-26
• Last Update Posted: 2013-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nurse education	Nurse education	Meets with oncology nurse
Mindfulness training	Mindfulness training	Taught Mindfulness meditation

Primary Outcome Measures

Name	Time	Method
Psychological functioning	1 year

Secondary Outcome Measures

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

Trial Locations

Locations (3)

University of Massachusetts Medical School; 🇺🇸 Worcester, Massachusetts, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States