Physical and Occupational Therapy for Bone Marrow Transplant Patients

Overseen By Stephen Rego

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: No BMT admission history

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

75 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Physical and Occupational Therapy for Bone Marrow Transplant Patients?

Research shows that occupational therapy can help manage psychosocial and environmental problems in cancer patients, and physical therapy is linked to improved mobility in patients with orthopedic issues. These findings suggest that similar therapies could be beneficial for bone marrow transplant patients by addressing both physical and emotional needs. ^{1 2 3 4 5}

Is physical and occupational therapy safe for bone marrow transplant patients?

Research shows that physical and occupational therapy is generally safe for bone marrow transplant patients, though some studies have looked at specific risks like bleeding in children with low platelet counts. ^{6 7 8 9 10}

How does physical and occupational therapy differ from other treatments for bone marrow transplant patients?

Physical and occupational therapy for bone marrow transplant patients is unique because it focuses on improving quality of life and functional capacity through personalized rehabilitation, addressing complex musculoskeletal issues that arise post-transplant. Unlike standard drug treatments, this therapy involves a tailored approach to help patients regain strength and mobility, which is not universally standardized but is crucial for their recovery. ^{10 11 12 13 14}

Research Team

Sasha Stephen, MD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults aged 18 or older who are admitted for a bone marrow transplant (BMT) and have not had an inpatient BMT before. It's designed to see if adding physical and occupational therapy right from the start can help reduce complications and improve recovery.

Inclusion Criteria

I have undergone a bone marrow transplant.

I am 18 years or older and planning to undergo bone marrow transplantation.

Exclusion Criteria

I have never been hospitalized for a bone marrow transplant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Data Collection

Baseline data collection will be used to determine eligibility for the study

1 day

Intervention

Physical and occupational therapy consultation upon inpatient admission for bone marrow transplantation

During inpatient stay

Follow-up

Participants are monitored for complications, morbidity, length of inpatient stay, 30-day readmission, and 90-day mortality

Up to 90 days

Treatment Details

Interventions

• Physical and Occupational Therapy

Trial Overview The study tests whether early consultation with physical and occupational therapists can decrease problems, shorten hospital stays, lower chances of coming back to the hospital within 30 days, and reduce deaths within 90 days after a BMT.

Participant Groups

Group I: physical and occupational therapy Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Findings from Research

An occupational therapist identified and addressed various environmental and psychosocial issues faced by 49 pediatric oncology patients and their families, achieving a 63% solution rate for these problems.

Early intervention from the time of diagnosis was significantly more effective in resolving issues compared to interventions initiated at later stages of the illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification and management of psychosocial and environmental problems of children with cancer. Whitley, SB., Branscomb, BV., Moreno, H.[2012]

The case report details the rehabilitation process of a man with non-Hodgkin's lymphoma who received an allogenic stem cell transplant, highlighting the role of occupational therapy in his outpatient recovery.

The article emphasizes the importance of evidence-based practice in occupational therapy, as it connects clinical applications to systematic reviews, ensuring that treatment approaches are grounded in research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational Therapy Interventions for Adults With Cancer. Braveman, B., Hunter, EG., Nicholson, J., et al.[2017]

A study of 383 cancer patients revealed that 92% were 'promoters' of outpatient rehabilitation services, with a high Net Promoter Score (NPS) of 91.4, indicating strong satisfaction with the care received.

Key factors influencing patients' likelihood to recommend rehabilitation included feeling comfortable during the process and experiencing noticeable improvements in health and functioning, which were linked to achieving important clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding Patient Experience with Outpatient Cancer Rehabilitation Care. Wood, KC., Bertram, JJ., Kendig, TD., et al.[2023]

In a study involving 63 older adults with cancer, occupational therapy (OT) and physical therapy (PT) showed a significant improvement in activity expectations and self-efficacy compared to usual care, although both groups experienced a decline in overall functional status.

Despite the positive effects of OT/PT on certain outcomes, challenges such as recruitment difficulties and logistical barriers hindered the implementation of the intervention, highlighting the need for improved access to these services for older cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older Adults with Cancer: A Randomized Controlled Trial of Occupational and Physical Therapy. Pergolotti, M., Deal, AM., Williams, GR., et al.[2021]

In a study of 116 orthopedic patients, the duration of physical and occupational therapy was positively correlated with improved mobility scores at discharge, suggesting that more therapy hours can lead to better functional outcomes.

Patients received an average of 40.8 hours of therapy, resulting in a significant average change in mobility scores, indicating that increasing therapy duration may enhance recovery in inpatient rehabilitation settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between duration of therapy services in a comprehensive rehabilitation program and mobility at discharge in patients with orthopedic problems. Kirk-Sanchez, NJ., Roach, KE.[2022]

In a study of 99 cancer patients undergoing rehabilitation after hemopoietic stem cell or bone marrow transplants, adverse events (AEs) occurred in only 3.3% of therapy sessions, indicating a low immediate risk during rehabilitation.

However, patients with hemoglobin levels below 8.0 g/dL and platelet counts below 25 k/μL were found to have a significantly increased risk of AEs and critical events (CEs), highlighting the importance of monitoring these laboratory values during rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Laboratory Values and Adverse Events in Adults Post-Hematopoietic Stem Cell Transplant During and After Rehabilitation. Nielsen, KA., George, CLS., Gilchrist, LS.[2023]

In a study of 63 children undergoing hematopoietic stem cell transplant (HSCT) with severe thrombocytopenia, there were no major bleeding events during physical therapy (PT) and occupational therapy (OT), indicating a high safety profile for these interventions.

Only 5 minor bleeding events occurred during 346 therapy sessions (1.5%), showing that PT and OT can be safely administered without increasing the risk of bleeding complications in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of Rehabilitation Interventions in Children Undergoing Hematopoietic Stem Cell Transplant With Thrombocytopenia. Ibanez, K., Espiritu, N., Souverain, RL., et al.[2020]

Occupational therapy provided 4-5 times a week during inpatient hospitalization for pediatric hematopoietic cell transplantation (HCT) significantly helps improve strength, coordination, and independence in daily living activities, as shown in a study of 32 patients.

Patients receiving high-frequency occupational therapy experienced less decline in grip strength and daily living skills during their treatment and were able to return to baseline levels more quickly upon discharge compared to those receiving lower frequency therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Occupational Performance in Pediatric Hematopoietic Cell Transplant Recipients. Colman, J., Casto, SC., Wisner, E., et al.[2022]

In a study of 131 patients who underwent bone marrow transplants and were admitted to rehabilitation 147 times, 41% were transferred back to primary care, highlighting a significant risk of return to acute care after rehabilitation.

The study identified key factors, such as low platelet counts and specific cancer diagnoses, that can help predict the likelihood of patients returning to primary care, leading to the development of the RTP-BMT index as a predictive tool for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Return to primary service among bone marrow transplant rehabilitation inpatients: an index for predicting outcomes. Fu, JB., Lee, J., Smith, DW., et al.[2021]

A comprehensive literature review led to the development of a clear physical therapy (PT) pathway and protocol specifically designed for patients undergoing hematopoietic stem cell transplantation (HSCT), addressing their unique rehabilitation needs.

The paper emphasizes the importance of individualized exercise interventions and provides safe practice guidelines for physical therapists, ensuring that HSCT patients receive tailored and effective rehabilitation support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapy pathway and protocol for patients undergoing hematopoietic stem cell transplantation: Recommendations from The Eastern Mediterranean Blood and Marrow Transplantation (EMBMT) Group. Mohammed, J., Aljurf, M., Althumayri, A., et al.[2020]

Hematopoietic stem cell transplantation (HSCT) patients often experience musculoskeletal issues that can lead to long-term functional incapacity, highlighting the need for tailored physical therapy (PT) interventions to improve their quality of life post-transplant.

Currently, there is no standardized PT protocol for HSCT patients, which may result in inadequate care; therefore, the Physical Therapy Association for Graft Versus Host Disease has provided evidence-based recommendations to integrate PT into routine HSCT care to address these complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Physical Therapy before and after Hematopoietic Stem Cell Transplantation: White Paper Report. Mohammed, J., Smith, SR., Burns, L., et al.[2020]

The CaRE-4-alloBMT program, a 6-month rehabilitation initiative for patients undergoing allogeneic blood and marrow transplantation, includes personalized exercise plans and remote monitoring, aiming to improve patient outcomes and support during recovery.

This phase II randomized controlled trial will assess the feasibility and acceptability of the program in 80 patients, providing valuable insights for future larger-scale studies on rehabilitation after alloBMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A longitudinal multidimensional rehabilitation program for patients undergoing allogeneic blood and marrow transplantation (CaRE-4-alloBMT): Protocol for a phase II feasibility pilot randomized controlled trial. Tam, S., Kumar, R., Lopez, P., et al.[2023]

Bone marrow transplant survivors face more challenges in areas like vocational functioning and sexual difficulties compared to patients undergoing maintenance chemotherapy, indicating that the transplant process can lead to significant life disruptions.

Despite these objective difficulties, bone marrow transplant patients perceive their health similarly to chemotherapy patients and report low levels of psychological distress, suggesting resilience in their self-assessment of quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year adjustment of bone marrow transplant survivors. Altmaier, EM., Gingrich, RD., Fyfe, MA.[2022]

Bone marrow transplantation (BMT) is used to treat various diseases, and understanding the treatment regimens and complications is crucial for effective physical therapy interventions during patient recovery.

The article provides guidelines for physical therapists to evaluate and treat patients post-BMT, emphasizing the importance of tailored therapeutic approaches to address the unique challenges faced by these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapy for patients after bone marrow transplantation. James, MC.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Identification and management of psychosocial and environmental problems of children with cancer. [2012]

2. United States pubmed.ncbi.nlm.nih.gov

Occupational Therapy Interventions for Adults With Cancer. [2017]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Understanding Patient Experience with Outpatient Cancer Rehabilitation Care. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Older Adults with Cancer: A Randomized Controlled Trial of Occupational and Physical Therapy. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Relationship between duration of therapy services in a comprehensive rehabilitation program and mobility at discharge in patients with orthopedic problems. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Association Between Laboratory Values and Adverse Events in Adults Post-Hematopoietic Stem Cell Transplant During and After Rehabilitation. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of Rehabilitation Interventions in Children Undergoing Hematopoietic Stem Cell Transplant With Thrombocytopenia. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Improving Occupational Performance in Pediatric Hematopoietic Cell Transplant Recipients. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Return to primary service among bone marrow transplant rehabilitation inpatients: an index for predicting outcomes. [2021]

10. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Physical therapy pathway and protocol for patients undergoing hematopoietic stem cell transplantation: Recommendations from The Eastern Mediterranean Blood and Marrow Transplantation (EMBMT) Group. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Role of Physical Therapy before and after Hematopoietic Stem Cell Transplantation: White Paper Report. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

A longitudinal multidimensional rehabilitation program for patients undergoing allogeneic blood and marrow transplantation (CaRE-4-alloBMT): Protocol for a phase II feasibility pilot randomized controlled trial. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Two-year adjustment of bone marrow transplant survivors. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Physical therapy for patients after bone marrow transplantation. [2019]