Evaluating Clinical Evaluation Tools for Predicting Risk of Complications After Hematopoietic Stem Cell Transplant

Study Overview
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Brief Summary
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This study evaluates whether clinical evaluation tools such as the six-minute walk test, hand grip strength test, and gait speed test, are useful in predicting risk of complications in patients undergoing hematopoietic stem cell transplants (HCT). Being able to predict who is at increased risk of post-HCT complications can help better inform patients and providers on the risks and benefits of undergoing HCT and determine whether certain patients should have closer post-HCT monitoring due to an increased risk of complications.

Detailed Description
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PRIMARY OBJECTIVE: I. To develop novel pre-transplant tools for determining risk of post-HCT pulmonary complications. OUTLINE: This is an observational study. Patients undergo a clinical evaluation consisting of a six-minute walk test, hand grip strength test, and gait speed test on study. Patients' medical records are also reviewed for a year on study.

Official Title
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Developing Novel Tools for Determining Risk of Respiratory Complications Following Hematopoietic Stem Cell Transplant

Conditions
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Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm

Intervention / Treatment
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* Other: Clinical Evaluation
* Other: Electronic Health Record Review


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (age >= 18 years old) Undergoing evaluation for autologous or allogeneic bone marrow transplant (HCT) at Mayo Clinic Rochester Scheduled for pre-HCT pulmonary function test by the primary team Exclusion Criteria: Limited mobility requiring use of gait aid or wheelchair Fall risk

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (clinical evaluation, record review)<br>Patients undergo a clinical evaluation consisting of a six-minute walk test, hand grip strength test, and gait speed test on study. Patients' medical records are also reviewed for a year on study. | Other: Clinical Evaluation<br>* Undergo clinical evaluation<br>* Other names: Clinical Assessment;Other: Electronic Health Record Review<br>* Medical records reviewed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary complication following hematopoietic stem cell transplant (HCT) | Pulmonary complications may include but are not limited to: infection, HCT-specific lung injury syndromes, acute respiratory distress syndrome, pulmonary graft versus host disease. Univariable analysis will be first used to identify potential factors that predict post-HCT pulmonary complications. All possible factors will then be included in multivariable analysis. Will also specifically test whether the six-minute walk test, grip strength and gait speed add additional significance to pulmonary complications and the statistic model after including pulmonary function test results. | Up to 1 year after transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 100-day mortality | Analyses similar to those for the primary outcome will be conducted. | At 100 days after transplant | 
| 1 year mortality | Analyses similar to those for the primary outcome will be conducted. | At 1 year after transplant | 
| Relapse-free survival | Analyses similar to those for the primary outcome will be conducted. | At 1 year after transplant | 
| Hospital or intensive care unit admission post-HCT | Will specifically test whether the six-minute walk test, grip strength and gait speed add additional significance to pulmonary complications and the statistic model after including pulmonary function test results. | Up to 1 year after transplant | 
| Need for noninvasive or invasive mechanical ventilation | Will specifically test whether the six-minute walk test, grip strength and gait speed add additional significance to pulmonary complications and the statistic model after including pulmonary function test results. | Up to 1 year after transplant |