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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding physical and occupational therapy sessions for patients undergoing a bone marrow transplant can reduce complications and shorten hospital stays. Researchers seek to discover whether these therapy sessions lead to fewer problems, fewer hospital readmissions within 30 days, and lower death rates within 90 days after treatment. The trial involves both retrospective analysis of past patient data and observation of new patients receiving these therapies. It is suitable for adults who have undergone a bone marrow transplant. As a Phase 2 trial, it focuses on assessing the effectiveness of these therapies in an initial, smaller group, offering participants a chance to contribute to important research.

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 prior data suggests that physical and occupational therapy is safe for bone marrow transplant patients?

Research has shown that physical and occupational therapy is generally safe for patients undergoing bone marrow transplants. Exercise therapy helps keep patients physically active and improves their quality of life post-transplant. For example, one study on patients who had hematopoietic stem cell transplants (HSCT) found that therapy alleviates common muscle and joint problems after transplants.

Another study examined the safety of rehabilitation exercises and found they can be performed safely even when patients have low platelet counts. This means the exercises can be tailored to each patient's needs without causing harm.

Overall, physical and occupational therapy is well-tolerated by bone marrow transplant patients, with no major reports of negative effects. This makes them a promising part of patient care during and after transplants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using physical and occupational therapy for bone marrow transplant patients because these therapies focus on boosting patients' strength and independence right from the start. Unlike traditional treatments that mostly focus on medical interventions, these therapies offer a proactive approach called "prehabilitation." Prehabilitation aims to prepare the body for the stresses of transplant procedures, potentially leading to faster recovery times and improved quality of life. This shift from merely treating symptoms to actively preparing patients sets it apart from standard care.

What evidence suggests that physical and occupational therapy is effective for bone marrow transplant patients?

Research shows that physical and occupational therapy can benefit individuals undergoing bone marrow transplants. In this trial, participants will receive these therapies as part of their treatment. Studies have found that such therapies prevent loss of physical ability, reduce fatigue, and improve overall well-being. Patients who receive therapy before and after their transplant often experience fewer muscle and joint problems, which can lead to long-term issues. Additionally, therapy is linked to fewer complications and shorter hospital stays. Overall, these therapies contribute to a smoother recovery process for transplant patients. ^{2 3 4 6 7}

Who Is on the Research Team?

Sasha Stephen, MD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11931774/

Rehabilitation after bone marrow transplant compared with ... The primary aim of this study is to investigate the effectiveness of an eight-week multidisciplinary rehabilitation intervention compared with usual care on the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05978583

Impact of Physical and Occupational Therapy in New BMT ... This is a single-site, non-randomized, observational study designed to evaluate the impact of adding physical and occupational therapy consultation upon ...

3. astctjournal.org astctjournal.org/article/S1083-8791(19)30067-9/fulltext

Role of Physical Therapy before and after Hematopoietic ... Hematopoietic stem cell transplantation (HSCT) patients can suffer from various musculoskeletal problems resulting in long-term functional incapacity.

4. journals.lww.com journals.lww.com/hosct/fulltext/2024/17030/rehabilitation_practices_during_hematopoietic_stem.3.aspx

Rehabilitation practices during hematopoietic stem cell tran... This study aimed to analyze the rehabilitation practices for hospitalized patients receiving HSCT across a cohort of international cancer centers.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10480509/

Effect of rehabilitation in patients undergoing hematopoietic ... Rehabilitation for HSCT patients is effective in preventing decline in physical function, reducing fatigue, and improving QOL.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11192508/

Assessment of rehabilitation practices during ... We obtained data on patient characteristics, rehabilitation therapy details (timing, indication, administering providers), physical function objective and ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999317305373

Safety and Feasibility of Rehabilitation Interventions in ... Objective. To analyze the relation between platelet counts, intensities of physical therapy (PT) and occupational therapy (OT) services received, ...