Transplant Wellness Clinic for Stem Cell Transplant Complications

Overseen By Linda Baer, APRN

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Not transplant candidate

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

Compensation: Varies

Number of Visits: 1

20 Participants Needed

Trial Summary

What is the purpose of this trial?

As the average age of individuals undergoing stem cell transplant continues to increase, challenges associated with balancing the side effects of cancer treatments while also managing other medical conditions develop. Studies have shown these individuals develop more treatment related side effects and take longer to leave the hospital due to complications. The purpose of this study is to develop a multiple provider clinic that will help identify any additional needs in the more complicated and generally older transplant patient population. If needed, this clinic will recommend interventions or referrals to the appropriate specialties to the participant and the transplant physician for the participant before your transplant procedure. Examples of potential areas of improvement include a course of physical therapy, nutritional supplements, or modifications of medications, among others with the goal to make your transplant safer and to decrease length of time in the hospital.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It mentions that medication modifications might be recommended, but it's best to discuss your specific situation with the trial team.

What data supports the effectiveness of the Transplant Wellness Clinic treatment for stem cell transplant complications?

Research suggests that guided exercise and mindfulness programs can improve quality of life and physical fitness for stem cell transplant survivors. Additionally, exercise programs have been shown to help maintain strength and mobility during and after hospitalization for stem cell transplants. ^{1 2 3 4 5}

Is the Transplant Wellness Clinic for Stem Cell Transplant Complications generally safe for humans?

The donation of hematopoietic stem cells, which is part of the transplant process, is considered safe, with the main risks being related to anesthesia and some pain at the donation site. Serious complications from the transplant itself can occur, such as infections and liver issues, but these are related to the transplant procedure rather than the clinic specifically. ^{6 7 8 9 10}

How is the Transplant Wellness Clinic treatment different from other treatments for stem cell transplant complications?

The Transplant Wellness Clinic is unique because it uses a nurse-allied health multidisciplinary approach, rather than relying solely on specialist physicians, to manage the complex health issues that arise after stem cell transplantation. This collaborative model may offer more comprehensive and personalized care for patients dealing with post-transplant complications. ^{11 12 13 14 15}

Research Team

Linda M Baer, APRN

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Brenda H Cooper, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Eligibility Criteria

This trial is for stem cell transplant candidates aged over 60 or younger patients with significant health complexities. Participants must be outpatients, able to attend appointments, read and understand English for questionnaires, and have a window of 4-12 weeks before their transplant starts. It's not open to those deemed unsuitable for transplantation.

Inclusion Criteria

I have a way to get to my outpatient appointments.

Must be able to read and understand English to complete the required questionnaires

I am young and have a high health complexity score.

Exclusion Criteria

I am not considered a candidate for stem cell transplant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplant Wellness Clinic

Participants undergo a comprehensive multidisciplinary geriatric assessment, including physical therapy consult, medication review, and nutrition survey

1 day

1 visit (in-person)

Pre-Transplant Preparation

Recommendations made and given to the participant and sent to the referring MD. Participant receives post clinic phone call before transplant.

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after transplant, including length of stay and readmission rates

Up to 6 months

Treatment Details

Interventions

• Transplant Wellness Clinic

Trial Overview The study aims to create a clinic that assesses the needs of older or high-risk patients undergoing bone marrow transplants (BMT). It includes comprehensive evaluations like physical therapy consults, nutrition assessments, cognitive tests, medication reviews and follow-ups to potentially improve outcomes and reduce hospital stays.

Participant Groups

Group I: Transplant Wellness Clinic Experimental Treatment 9 Interventions

* Physical therapy consult * Intake vitals * CARG online survey, mental status exam * Medication review * Nutrition survey * Social work: available on prn basis (as-needed) * Exit survey Recommendations made and given to the participant and sent to the referring MD. Participant receives post clinic phone call before transplant. Referring MD receives questionnaires. Data collected depending on if participant moved forward with transplant

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Findings from Research

The 'Exercise is Medicine' initiative significantly improved patient outcomes during stem-cell transplants, with the completion rate of physical therapy sessions increasing from 71% to 87%.

After the intervention, 79% of patients showed improvement in their functional strength as measured by the 1-minute sit-to-stand test, and 92% participated in the Miles in Motion program, indicating enhanced independent activity during hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise is Medicine: Implementing a New Initiative to Increase Patients' Activity and Functional Mobility in Pediatric Stem-Cell Transplant Unit. Robey, L., Schreck, H., Eames, G., et al.[2022]

An exercise program before hematopoietic stem cell transplantation (HSCT) is safe and feasible, with no reported adverse events among the 29 participants in the study.

Preliminary results indicate that the exercise program may improve self-perceived physical functioning, quality of life, and fatigue, suggesting potential benefits for patients awaiting HSCT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise prior to hematopoietic stem cell transplantation: A feasibility study. van Haren, IEPM., Staal, JB., Potting, CM., et al.[2018]

Physical exercise interventions during hospitalization for hematopoietic stem cell transplantation (HSCT) significantly improve quality of life and reduce fatigue in patients, as shown in a meta-analysis of 11 studies involving 734 participants.

While exercise showed positive effects on quality of life and fatigue, it did not have a marked impact on psychological well-being and distress, indicating that while beneficial, exercise may not address all aspects of recovery for HSCT patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise for patients undergoing hematopoietic stem cell transplantation: systematic review and meta-analyses of randomized controlled trials. van Haren, IE., Timmerman, H., Potting, CM., et al.[2019]

A 6-week virtual, home-based exercise and mindfulness-based stress management program was successfully completed by 21 out of 24 participants, showing significant improvements in physical fitness and quality of life for survivors of hemopoietic cell transplantation (HCT).

Participants demonstrated enhanced physical capacity, as evidenced by improved scores in the six-minute walk test and sit-to-stand test at 3 and 12 months post-program, with no reported adverse events, indicating the program's safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential benefits of a virtual, home-based combined exercise and mindfulness training program for HSC transplant survivors: a single-arm pilot study. Ma, DDF., Fennessy, K., Kliman, D.[2022]

In a study of 76 patients undergoing hematopoietic stem cell transplantation, daily electronic symptom reporting significantly reduced peak symptom burden during the first two weeks post-transplant, with an average symptom score of 10.4 compared to 14.5 in the control group (p=0.03).

The use of patient-reported outcomes (PROs) allowed for better monitoring and management of symptoms, suggesting that this intervention could improve patient care in bone marrow transplant settings and warrants further multi-site trials to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomized trial of an electronic symptom monitoring and reporting intervention for hospitalized adults undergoing hematopoietic stem cell transplantation. Bryant, AL., Coffman, E., Phillips, B., et al.[2021]

The review of 18 studies on hematopoietic stem cell transplantation found that mild and moderate adverse reactions were most common, with nausea and vomiting being the most frequently reported issues.

The cardiovascular, respiratory, and gastrointestinal systems were the most affected by these adverse reactions, highlighting the need for monitoring these organ systems during and after the infusion of stem cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse reactions on day zero of hematopoietic stem cell transplantation: integrative review. Figueiredo, TWB., Mercês, NNAD., Nunes, MBM., et al.[2022]

Over half (54.1%) of allogeneic hematopoietic stem cell transplant (HSCT) survivors reported using at least one form of complementary and alternative medicine (CAM), indicating a significant interest in these therapies among this population.

The study highlights a critical need for further research to evaluate the safety and efficacy of various CAM therapies, as some may offer benefits while others could pose risks or have no effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidemiology of complementary and alternative medicine therapy use in allogeneic hematopoietic stem cell transplant survivorship patients in Australia. Lindsay, J., Kabir, M., Gilroy, N., et al.[2021]

Allogeneic hematopoietic stem cell transplantation (HSCT) is a critical treatment option for various diseases, but it carries risks of morbidity and mortality, highlighting the importance of donor safety during the stem cell donation process.

Bone marrow donation is a well-established and generally safe procedure, with a low incidence of serious adverse events (only 1 fatal event reported among 27,770 donations), and the most common side effects being pain and fatigue, indicating that careful donor selection is essential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of bone marrow stem cell donation: a review. Bosi, A., Bartolozzi, B.[2010]

Bone marrow transplant (BMT) is a preferred treatment for certain blood diseases, but it carries significant risks, including complications from the conditioning regimen like neutropenia and thrombocytopenia, which can lead to infections and bleeding.

Graft-versus-host disease (GVHD) is a common complication after allogeneic BMT, occurring when donor T cells attack the recipient's tissues, and patients require ongoing medical care for about a year post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-bone marrow transplant patient management. Poliquin, CM.[2018]

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 91 patients who underwent allogeneic stem cell transplant, a significant number experienced long-term complications, including ocular issues (50.6%), metabolic syndrome (37.4%), and skeletal complications (66.7%), highlighting the need for comprehensive follow-up care.

The study emphasizes that early detection of these complications through systematic evaluations can reduce mortality and morbidity, suggesting that the long-term follow-up guidelines implemented in this clinic could be beneficial for other transplant centers as well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Guideline-Driven Approach in Follow-Up of Long-Term Complications After Allogeneic Hematopoietic Cell Transplant: Single Center Experience. Kaya, AH., Namdaroğlu, S., Kayıkcı, Ö., et al.[2021]

Hematopoietic stem cell transplantation (HSCT) is crucial for treating many blood cancers and genetic disorders, but using alternative donors can lead to complications like graft rejection and graft-versus-host disease (GvHD).

Current strategies, such as reconstituting patients with antigen-specific T cells, can effectively prevent viral infections post-transplant while minimizing harmful immune reactions, offering a promising approach to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges of T cell therapies for virus-associated diseases after hematopoietic stem cell transplantation. Leen, AM., Tripic, T., Rooney, CM.[2021]

A nurse-allied health multidisciplinary clinic was implemented for patients after hematopoietic stem cell transplantation (HSCT), involving six disciplines and reviewing 57 patients with an average of 8.3 reviews each, focusing on comprehensive care.

While the clinic did not reduce readmission rates, it received positive feedback from patients and physicians, highlighting unmet needs in areas like fatigue management and quality of life, indicating room for improvement in post-transplant care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and evaluation of a nurse-allied health clinic for patients after haematopoietic stem cell transplantation. Nakagaki, M., Gavin, NC., Hayes, T., et al.[2021]

Stem cell transplantation (SCT) is becoming a common medical practice, leading to improved outcomes for patients, which means more people are living after transplantation.

Understanding the various non-infective complications that can arise post-transplant, as detected through imaging, is crucial for healthcare providers in managing patient care effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-infectious manifestations of stem cell transplantation. Beckett, D., Olliff, J.[2005]

Survivors of allogeneic stem cell transplants (allo-SCT) face a range of long-term endocrine and metabolic complications, including diabetes, hypertension, and cardiovascular disease, which need careful monitoring and management.

The review highlights the importance of evaluating and treating these complications to improve the quality of life for transplant survivors, as survival rates continue to rise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endocrine complications in long-term survivors after allogeneic stem cell transplant. Gunasekaran, U., Agarwal, N., Jagasia, MH., et al.[2012]

References

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

Exercise is Medicine: Implementing a New Initiative to Increase Patients' Activity and Functional Mobility in Pediatric Stem-Cell Transplant Unit. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Physical exercise prior to hematopoietic stem cell transplantation: A feasibility study. [2018]

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

Physical exercise for patients undergoing hematopoietic stem cell transplantation: systematic review and meta-analyses of randomized controlled trials. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Potential benefits of a virtual, home-based combined exercise and mindfulness training program for HSC transplant survivors: a single-arm pilot study. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Pilot randomized trial of an electronic symptom monitoring and reporting intervention for hospitalized adults undergoing hematopoietic stem cell transplantation. [2021]

6. Brazil pubmed.ncbi.nlm.nih.gov

Adverse reactions on day zero of hematopoietic stem cell transplantation: integrative review. [2022]

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

Epidemiology of complementary and alternative medicine therapy use in allogeneic hematopoietic stem cell transplant survivorship patients in Australia. [2021]

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

Safety of bone marrow stem cell donation: a review. [2010]

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

Post-bone marrow transplant patient management. [2018]

10. 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]

11. Turkey pubmed.ncbi.nlm.nih.gov

Impact of Guideline-Driven Approach in Follow-Up of Long-Term Complications After Allogeneic Hematopoietic Cell Transplant: Single Center Experience. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Challenges of T cell therapies for virus-associated diseases after hematopoietic stem cell transplantation. [2021]

13. Germany pubmed.ncbi.nlm.nih.gov

Implementation and evaluation of a nurse-allied health clinic for patients after haematopoietic stem cell transplantation. [2021]

14. England pubmed.ncbi.nlm.nih.gov

Non-infectious manifestations of stem cell transplantation. [2005]

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

Endocrine complications in long-term survivors after allogeneic stem cell transplant. [2012]