Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT03870750
Eligibility Criteria:
Inclusion Criteria:
* Vulnerable patients as defined by one or more of the following criteria
* Age 65 years or older
* Having Hematopoietic Cell Transplantation - Comorbidity Index (HCT-CI) scores of \>= 3 (for patients that could be 20 years old and older)
* Having frailty as determined by walk speed of \< 0.8 m/s using 4-meter walk test (for patients 50 years old and older)
* Patients considered or referred for allogeneic HCT to treat a hematological malignant or non-malignant disease
* Able to speak and read English - interaction with the interventionist trainer and endpoint measurement must occur in English
* Willing and able to provide informed consent
* Planned allogeneic HCT within 3 weeks - all types of donors and all sorts of conditioning regimens are allowed. Patients with suspected active disease (relatively old disease staging or relatively old intervention) or significant comorbidity (e.g. suspicious untreated pulmonary nodules) based on prior evaluations, that could delay the transplant would be considered for enrollment within a tighter window (10-14 days before allogeneic HCT) to allow for completed pre-HCT work-up evaluations that would confirm readiness to proceed with transplant
* Able to exercise at low to moderate intensity, specifically taking into consideration the rare circumstances where subjects are not able to exercise due to either birth deformity or prior traumatic injury that affects their gait
* Adequate cardiopulmonary reserve, as judged by data from the patient's electronic medical record as to whether a patient could walk up one flight of stairs, no need for supplemental oxygen, and/or physician judgment
Exclusion Criteria:
* Orthopedic, neurologic or other problems which prevent safe ambulation and protocol adherence. Information on prior falls and other recent orthopedic or neurologic problems will be used to make judgment about protocol eligibility
* Participation in another intervention clinical trial with HRQOL as a primary endpoint
* Planned donor lymphocyte infusion (DLI) within 90 days post-transplant
* Planned anti-cytotoxic therapies, other than tyrosine kinase inhibitors or single-agent monoclonal antibody, or FLT-3 inhibitors within 90 days of post-transplant unless pre-approved by the protocol principal investigator (PI)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT03870750
Study Brief:
Protocol Section:
NCT03870750