Mindfulness Meditation in Bone Marrow Transplantation

Sponsor

Emory University (Other)

Overall Status

Completed

CT.gov ID

NCT00165282

Collaborator

Dana-Farber Cancer Institute (Other), University of Massachusetts, Worcester (Other)

241

Enrollment

Locations

Arms

Duration (Months)

80.3

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematologic Malignancy Bone Marrow Transplantation Stem Cell Transplantation	Behavioral: Mindfulness training Behavioral: Nurse education	Phase 2/Phase 3

Detailed Description

Patients will be assigned to one of three study groups:

receives the normal standard care;
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
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 Design

Study Type:

Interventional

Actual Enrollment :

241 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

Mindfulness Meditation in Bone Marrow Transplantation

Study Start Date :

Apr 1, 2005

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Psychological functioning [1 year]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University	Atlanta	Georgia	United States
2	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
3	University of Massachusetts Medical School	Worcester	Massachusetts	United States	01655