Back to resultsImpact of Physical and Occupational Therapy Therapy in New BMT Patients
Primary Purpose
Bone Marrow Transplantation, Bone Marrow Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
physical and occupational therapy consultation
Sponsored by
About this trial
This is an interventional supportive care trial for Bone Marrow Transplantation focused on measuring exercise, physical therapy
Eligibility Criteria
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
Sites / Locations
- Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel HillRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
physical and occupational therapy
Arm Description
Physical and occupational therapy consultation might be used to provide targeted prehabilitation interventions.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
The feasibility
The proportion of individuals who received a physical and occupational therapy consultation in the prospective group.
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.
Mortality rates
Mortality rates will be calculated by comparing, how many subjects died pre-intervention and post-intervention, using medical record data.
Complication types and rates
Complication types and rates will be calculated and compared pre-intervention and post-intervention using medical record data.
Full Information
NCT ID
NCT05978583
First Posted
July 28, 2023
Last Updated
October 23, 2023
Sponsor
UNC Lineberger Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05978583
Brief Title
Impact of Physical and Occupational Therapy Therapy in New BMT Patients
Official Title
Assessing the Impact of Physical and Occupational Therapy for Patients Admitted for Bone Marrow Transplant on Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Marrow Transplantation, Bone Marrow Disease
Keywords
exercise, physical therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
physical and occupational therapy
Arm Type
Other
Arm Description
Physical and occupational therapy consultation might be used to provide targeted prehabilitation interventions.
Intervention Type
Other
Intervention Name(s)
physical and occupational therapy consultation
Intervention Description
Physical and occupational therapy consultation during the inpatient admission period. This information may be used in the future to provide targeted prehabilitation interventions.
Primary Outcome Measure Information:
Title
30-day readmission
Description
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).
Time Frame
Up to 30 days after bone marrow transplantation
Secondary Outcome Measure Information:
Title
The feasibility
Description
The proportion of individuals who received a physical and occupational therapy consultation in the prospective group.
Time Frame
1 day (the date of bone marrow transplantation)
Title
Acute care length of stay
Description
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.
Time Frame
Up to 90 days after bone marrow transplantation
Title
Mortality rates
Description
Mortality rates will be calculated by comparing, how many subjects died pre-intervention and post-intervention, using medical record data.
Time Frame
Up to 90 days after bone marrow transplantation
Title
Complication types and rates
Description
Complication types and rates will be calculated and compared pre-intervention and post-intervention using medical record data.
Time Frame
Up to 90 days after bone marrow transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sasha Knowlton
Phone
984 974 0293
Email
sknow@email.unc.ed
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Rego
Email
stephen_rego@med.unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sasha Stephen, MD
Organizational Affiliation
UNC Lineberger Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sasha Knowlton
First Name & Middle Initial & Last Name & Degree
Sasha E Knowlton, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
Description
University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials
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Impact of Physical and Occupational Therapy Therapy in New BMT Patients
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