NCT00165282

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2005

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

November 28, 2013

Status Verified

November 1, 2013

Enrollment Period

4.8 years

First QC Date

September 9, 2005

Last Update Submit

November 26, 2013

Conditions

Hematologic MalignancyBone Marrow TransplantationStem Cell Transplantation

Keywords

MeditationMindfulness meditationBone Marrow TransplantStem Cell Transplant

Outcome Measures

Primary Outcomes (1)

  • Psychological functioning

    1 year

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (3)

Usual Care

NO INTERVENTION

Normal standard of care

Nurse education

ACTIVE COMPARATOR

Meets with oncology nurse

Behavioral: Nurse education

Mindfulness training

EXPERIMENTAL

Taught Mindfulness meditation

Behavioral: Mindfulness training

Interventions

Mindfulness trainingBEHAVIORAL

Taught mindfulness meditation by mindfulness instructor (trained health care professional/RN) and audio c/d

Mindfulness training
Nurse educationBEHAVIORAL

Meets with oncology nurse to have questions answered about medical treatments and side effects

Nurse education

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Autologous stem cell transplantation for hematologic malignancy
  • First transplant
  • years of age or older
  • Speaks and understands English

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Emory University

Atlanta, Georgia, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Susan Bauer-Wu, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

April 1, 2005

Primary Completion

January 1, 2010

Study Completion

June 1, 2011

Last Updated

November 28, 2013

Record last verified: 2013-11

Locations

US(3)