- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05978583
Impact of Physical and Occupational Therapy in New BMT Patients
December 5, 2025 updated by: UNC Lineberger Comprehensive Cancer Center
Assessing the Impact of Physical and Occupational Therapy for Patients Admitted for Bone Marrow Transplant on Outcomes
This is a single-site, non-randomized, observational study designed to evaluate the impact of adding physical and occupational therapy consultation upon inpatient admission for a bone marrow transplantation (BMT).
The purpose of this study is to investigate whether consultation with physical and occupational therapists as part of the general admission order set for patients scheduled for bone marrow transplant will result in reduced complications, morbidity, length of inpatient stay, 30-day readmission, and 90-day mortality.
Baseline data collection will be used to determine eligibility.
This study will be partially retrospective (pre-implementation of physical and occupational therapy consultation order) and partially prospective.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Subjects who are admitted for bone marrow transplantation (BMT) at the study site.
Description
Inclusion Criteria:
- Age ≥ 18 years at the time of admission for bone marrow transplantation (BMT)
- Received BMT
Exclusion Criteria:
1. No history of inpatient admission for BMT
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
physical and occupational therapy
Physical and occupational therapy consultation might be used to provide targeted prehabilitation interventions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
30-day readmission
Time Frame: Up to 30 days after bone marrow transplantation
|
30-day readmission rates will be calculated using historical data (pre-intervention) and compared to rates once physical and occupational therapy consultation has been included in the inpatient admission order set for bone marrow transplantation (BMT).
|
Up to 30 days after bone marrow transplantation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The feasibility
Time Frame: 1 day (the date of bone marrow transplantation)
|
The proportion of individuals who received a physical and occupational therapy consultation in the prospective group.
|
1 day (the date of bone marrow transplantation)
|
|
Acute care length of stay
Time Frame: Up to 90 days after bone marrow transplantation
|
Acute care length of stay will be calculated using historical data (pre-intervention) and compared to rates once physical and occupational therapy consultation has been included in the inpatient admission order set for BMT.
|
Up to 90 days after bone marrow transplantation
|
|
Mortality rates
Time Frame: Up to 90 days after bone marrow transplantation
|
Mortality rates will be calculated by comparing, how many subjects died pre-intervention and post-intervention, using medical record data.
|
Up to 90 days after bone marrow transplantation
|
|
Complication types and rates
Time Frame: Up to 90 days after bone marrow transplantation
|
Complication types and rates will be calculated and compared pre-intervention and post-intervention using medical record data.
|
Up to 90 days after bone marrow transplantation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sasha Stephen, MD, UNC Lineberger Comprehensive Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Actual)
December 4, 2024
Study Completion (Actual)
December 4, 2024
Study Registration Dates
First Submitted
July 28, 2023
First Submitted That Met QC Criteria
August 4, 2023
First Posted (Actual)
August 7, 2023
Study Record Updates
Last Update Posted (Estimated)
December 15, 2025
Last Update Submitted That Met QC Criteria
December 5, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCCC2252
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bone Marrow Transplantation
-
National Center for Complementary and Integrative...National Cancer Institute (NCI)CompletedStem Cell Transplantation | Bone Marrow TransplantationUnited States
-
GlaxoSmithKlineCompletedBone Marrow TransplantationUnited States
-
Massachusetts General HospitalCompleted
-
Wake Forest University Health SciencesOhio State University; University of Mississippi Medical CenterCompletedBone Marrow TransplantationUnited States
-
Hospital Israelita Albert EinsteinCompletedImpact of Yoga and Gentle Massage Practices on Symptom Management in Patients Undergoing HSCT (Yoga)Bone Marrow Transplantation | Hematopoietic Stem Cell TransplantationBrazil
-
National Institute of Allergy and Infectious Diseases...CompletedBone Marrow TransplantationUnited States
-
Ming-Yuan ChihCompleted
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedBone Marrow Transplantation
-
University of California, San FranciscoCompleted
-
Shaymaa Mohammed El-AwadyRecruitingAllogenic Bone Marrow TransplantationEgypt
Clinical Trials on physical and occupational therapy consultation
-
University of ArizonaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedCerebral PalsyUnited States
-
UNC Lineberger Comprehensive Cancer CenterCompletedCancerUnited States
-
University Hospital Inselspital, BerneCompleted
-
Zuyd University of Applied SciencesMaastricht UniversityUnknown
-
Ruhr University of BochumDeutsche Gesetzliche Unfallversicherung (DGUV)UnknownPhantom Limb PainGermany
-
Washington University School of MedicineEnrolling by invitationMotor Neuron Disease | Amyotrophic Lateral Sclerosis | Lou Gehrig Disease | Familial Amyotrophic Lateral Sclerosis | Motor Neuron Disease, FamilialUnited States
-
Associação de Assistência a Criança DeficienteCompletedAcquired Brain Injury | Poliomyelitis | Spinal Cord Injury
-
University of Colorado, DenverNational Institutes of Health (NIH)RecruitingEmergency Department | Fall Prevention | Telehealth | Older Adults (65 Years and Older)United States
-
Samsung Medical CenterRecruitingCritical Illness | Pediatric Intensive Care UnitSouth Korea
-
Cairo UniversityCompletedSports Physical TherapyEgypt