Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
Conditions
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.
Interventions
OTHERClinical Evaluation
Undergo clinical evaluation
OTHERElectronic Health Record Review
Medical records reviewed
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed