NCT05978583

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

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

January 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2024

Completed
Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

1.9 years

First QC Date

July 28, 2023

Last Update Submit

December 5, 2025

Conditions

Keywords

exercisephysical therapy

Outcome Measures

Primary Outcomes (1)

  • 30-day readmission

    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 Outcomes (4)

  • The feasibility

    1 day (the date of bone marrow transplantation)

  • Acute care length of stay

    Up to 90 days after bone marrow transplantation

  • Mortality rates

    Up to 90 days after bone marrow transplantation

  • Complication types and rates

    Up to 90 days after bone marrow transplantation

Study Arms (1)

physical and occupational therapy

Physical and occupational therapy consultation might be used to provide targeted prehabilitation interventions.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects who are admitted for bone marrow transplantation (BMT) at the study site.

You may qualify if:

  • Age ≥ 18 years at the time of admission for bone marrow transplantation (BMT)
  • Received BMT

You may not qualify if:

  • \. No history of inpatient admission for BMT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

MeSH Terms

Conditions

Bone Marrow DiseasesMotor Activity

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesBehavior

Study Officials

  • Sasha Stephen, MD

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2023

First Posted

August 7, 2023

Study Start

January 1, 2023

Primary Completion

December 4, 2024

Study Completion

December 4, 2024

Last Updated

December 15, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations