Clinical trial NCT00165282: Mindfulness Meditation in Bone Marrow Transplantation
Official title: Mindfulness Meditation in Bone Marrow Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hematologic Malignancy
Bone Marrow Transplantation
Stem Cell Transplantation
Keywords: Meditation
Mindfulness meditation
Bone Marrow Transplant
Stem Cell Transplant
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: University of Massachusetts, Worcester
First posted: 2005-09-14
Enrollment: 241
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Psychological functioning
timeFrame: 1 year
Secondary outcomes:
measure: Number of days to bone marrow engraftment
timeFrame: 1 year
measure: Medication use
timeFrame: 1 year
measure: Urinary stress hormones (cortisol and catecholamines)
timeFrame: 1 year
measure: Transplant related complications
timeFrame: 1 year
measure: Hospital length of stay and re-hospitalizations
timeFrame: 1 year
measure: Physical symptoms
timeFrame: 1 year
measure: Quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: Emory University
name: Susan Bauer-Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References: