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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05978583
Other study ID # LCCC2252
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date October 31, 2024

Study information

Verified date October 2023
Source UNC Lineberger Comprehensive Cancer Center
Contact Sasha Knowlton
Phone 984 974 0293
Email sknow@email.unc.ed
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single-site, non-randomized, interventional 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date October 31, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age = 18 years at the time of admission for bone marrow transplantation (BMT) 2. Received BMT Exclusion Criteria: 1. No history of inpatient admission for BMT

Study Design


Intervention

Other:
physical and occupational therapy consultation
Physical and occupational therapy consultation during the inpatient admission period. This information may be used in the future to provide targeted prehabilitation interventions.

Locations

Country Name City State
United States Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill Chapel Hill North Carolina

Sponsors (1)

Lead Sponsor Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The feasibility The proportion of individuals who received a physical and occupational therapy consultation in the prospective group. 1 day (the date of bone marrow transplantation)
Secondary Acute care length of stay 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
Secondary Mortality rates 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
Secondary Complication types and rates 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
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