Mindfulness Meditation in Bone Marrow Transplantation

Hematologic Malignancy Clinical Trial

Official title:

Mindfulness Meditation in Bone Marrow Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165282
• Other study ID #: IRB00005285
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 9, 2005
• Last updated: November 26, 2013
• Start date: April 2005
• Est. completion date: June 2011

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: June 2011
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bone Marrow Transplantation
• Hematologic Malignancy
• Stem Cell Transplantation

Intervention

Behavioral:
• Mindfulness training
Taught mindfulness meditation by mindfulness instructor (trained health care professional/RN) and audio c/d
• Nurse education
Meets with oncology nurse to have questions answered about medical treatments and side effects

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	Dana-Farber Cancer Institute, University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological functioning		1 year	No
Secondary	Number of days to bone marrow engraftment		1 year	No
Secondary	Medication use		1 year	No
Secondary	Urinary stress hormones (cortisol and catecholamines)		1 year	No
Secondary	Transplant related complications		1 year	No
Secondary	Hospital length of stay and re-hospitalizations		1 year	No
Secondary	Physical symptoms		1 year	No
Secondary	Quality of life		1 year	No