Hematologic MalignancyPhase 2/3NCT00165282
Mindfulness Meditation in Bone Marrow Transplantation
A Phase 2/3 study testing Mindfulness training and Nurse education in people with Hematologic Malignancy and Bone Marrow Transplantation, run by Emory University at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hematologic Malignancy, Bone Marrow Transplantation, Stem Cell Transplantation
- What is being tested?
- Mindfulness training and Nurse education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2005to Jun 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Autologous stem cell transplantation for hematologic malignancy
- First transplant
- 21 years of age or older
- Speaks and understands English
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University
Atlanta, Georgia
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
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:
- 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.
- Being tested
- Mindfulness training, Nurse education
- Keywords
- Meditation, Mindfulness meditation, Bone Marrow Transplant, Stem Cell Transplant
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness trainingBehavioural
Taught mindfulness meditation by mindfulness instructor (trained health care professional/RN) and audio c/d
Nurse educationBehavioural
Meets with oncology nurse to have questions answered about medical treatments and side effects
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Normal standard of care |
| Nurse education | Active comparator | Meets with oncology nurse Receives: Behavioral: Nurse education |
| Mindfulness training | Experimental | Taught Mindfulness meditation Receives: Behavioral: Mindfulness training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological functioning
Measured: 1 year
Secondary outcomes (7)
Number of days to bone marrow engraftment
Measured: 1 year
Medication use
Measured: 1 year
Urinary stress hormones (cortisol and catecholamines)
Measured: 1 year
Transplant related complications
Measured: 1 year
Hospital length of stay and re-hospitalizations
Measured: 1 year
Physical symptoms
Measured: 1 year
Quality of life
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionJan 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Bauer-Wu, PhD, RN, FAAN, University of Virginia
- Investigators
- Susan Bauer-Wu, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165282
- Sponsor's protocol ID
- IRB00005285
- Status last verified
- Nov 2013
- First submitted
- 9 Sep 2005
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Meditation in Bone Marrow Transplantation
- ClinicalTrials.gov ID
- NCT00165282
- Acronym / sponsor ID
- IRB00005285
- Keywords
- Meditation, Mindfulness meditation, Bone Marrow Transplant, Stem Cell Transplant
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, University of Massachusetts, Worcester
- Study start
- Apr 2005
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Normal standard of care |
| Nurse education | Active comparator | Behavioral: Nurse educationMeets with oncology nurse |
| Mindfulness training | Experimental | Behavioral: Mindfulness trainingTaught Mindfulness meditation |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Autologous stem cell transplantation for hematologic malignancy
- First transplant
- 21 years of age or older
- Speaks and understands English
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness trainingTaught mindfulness meditation by mindfulness instructor (trained health care professional/RN) and audio c/d | Behavioural | Mindfulness training |
| Nurse educationMeets with oncology nurse to have questions answered about medical treatments and side effects | Behavioural | Nurse education |
Primary outcome
Psychological functioning
Time frame: 1 year
7 secondary outcomes
Number of days to bone marrow engraftment
Time frame: 1 year
Medication use
Time frame: 1 year
Urinary stress hormones (cortisol and catecholamines)
Time frame: 1 year
Transplant related complications
Time frame: 1 year
Hospital length of stay and re-hospitalizations
Time frame: 1 year
Physical symptoms
Time frame: 1 year
Quality of life
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Bauer-Wu, PhD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mindfulness training and Nurse education in people with Hematologic Malignancy and Bone Marrow Transplantation, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological functioning (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2013.