Impact of Physical and Occupational Therapy Therapy in New BMT Patients

• Sponsor: UNC Lineberger Comprehensive Cancer Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05978583
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 13
• Patients Per Site Per Month: 5.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Marrow Transplantation; Bone Marrow Disease	Other: physical and occupational therapy consultation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 75 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Assessing the Impact of Physical and Occupational Therapy for Patients Admitted for Bone Marrow Transplant on Outcomes
• Anticipated Study Start Date: Sep 30, 2023
• Anticipated Primary Completion Date: Oct 31, 2024
• Anticipated Study Completion Date: Oct 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: physical and occupational therapy Physical and occupational therapy consultation might be used to provide targeted prehabilitation interventions.	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.

Outcome Measures

Primary Outcome Measures

1. 30-day readmission [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).

Secondary Outcome Measures

1. The feasibility [1 day (the date of bone marrow transplantation)]

   The proportion of individuals who received a physical and occupational therapy consultation in the prospective group.

2. Acute care length of stay [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.

3. Mortality rates [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.

4. Complication types and rates [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599

Sponsors and Collaborators

• UNC Lineberger Comprehensive Cancer Center

Investigators

• Principal Investigator: Sasha Stephen, MD, UNC Lineberger Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Publications

None provided.

• Responsible Party: UNC Lineberger Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT05978583
• Other Study ID Numbers: LCCC2252
• First Posted: Aug 7, 2023
• Last Update Posted: Aug 7, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by UNC Lineberger Comprehensive Cancer Center: exercise; physical therapy
• Additional relevant MeSH terms: Bone Marrow Diseases

Study Results

No Results Posted as of Aug 7, 2023