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

NCT05766332 | Completed

• 2 other identifiers: 21-000913NCI-2022-01589
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 100-day mortality

  At 100 days after transplant

• 1 year mortality

  At 1 year after transplant

• Relapse-free survival

  At 1 year after transplant

• Hospital or intensive care unit admission post-HCT

  Up to 1 year after transplant

• Need for noninvasive or invasive mechanical ventilation

  Up to 1 year after transplant

Study Arms (1)

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; Other: Electronic Health Record Review

Interventions

Clinical Evaluation OTHER

Undergo clinical evaluation

Also known as: Clinical Assessment

Observational (clinical evaluation, record review)

Electronic Health Record Review OTHER

Medical records reviewed

Observational (clinical evaluation, record review)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing evaluation for autologous or allogeneic bone marrow transplant.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Hemang Yadav, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 13, 2023
• Study Start: August 2, 2021
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: January 10, 2025

Record last verified: 2025-01

Locations

US (1)