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

Recruiting

• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm
• Interventions: Other: Clinical Evaluation; Other: Electronic Health Record Review

• Registration Number: NCT05766332
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-07-19
• Study First Submitted: 2023-02-22
• Study First Submitted QC: 2023-03-02
• Study First Posted: 2023-03-13
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-12
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

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Exclusion Criteria

• Limited mobility requiring use of gait aid or wheelchair
• Fall risk

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (clinical evaluation, record review)	Clinical Evaluation	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.
Observational (clinical evaluation, record review)	Electronic Health Record Review	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.

Primary Outcome Measures

Name	Time	Method
Pulmonary complication following hematopoietic stem cell transplant (HCT)	Up to 1 year after transplant	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.

Secondary Outcome Measures

Name	Time	Method
100-day mortality	At 100 days after transplant	Analyses similar to those for the primary outcome will be conducted.
1 year mortality	At 1 year after transplant	Analyses similar to those for the primary outcome will be conducted.
Hospital or intensive care unit admission post-HCT	Up to 1 year after transplant	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.
Relapse-free survival	At 1 year after transplant	Analyses similar to those for the primary outcome will be conducted.
Need for noninvasive or invasive mechanical ventilation	Up to 1 year after transplant	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States