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

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05766332

Collaborator

National Cancer Institute (NCI) (NIH)

200

Enrollment

Locations

Anticipated Duration (Months)

100

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm	Other: Clinical Evaluation Other: Electronic Health Record Review

Detailed Description

PRIMARY OBJECTIVE:

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Observational (clinical evaluation, 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.	Other: Clinical Evaluation Undergo clinical evaluation Other Names: Clinical Assessment Other: Electronic Health Record Review Medical records reviewed

Arm

Intervention/Treatment

Observational (clinical evaluation, 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.

Other: Clinical Evaluation

Undergo clinical evaluation

Other Names:

Clinical Assessment

Other: Electronic Health Record Review

Medical records reviewed

Outcome Measures

Primary Outcome Measures

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

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.
Relapse-free survival [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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Florida	Jacksonville	Florida	United States	32224-9980
2	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic
National Cancer Institute (NCI)

Investigators

Principal Investigator: Hemang Yadav, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05766332

Other Study ID Numbers:

21-000913
NCI-2022-01589
21-000913

First Posted:

Mar 13, 2023

Last Update Posted:

Mar 13, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Mar 13, 2023