Clinical Trial
Study Details
Status
RECRUITING
Study ID #
NCT05556928
Study Start
Primary Completion
Study Completion
Enrollment
5000
Study Type
Observational
Primary Outcomes
Measure
Create the CARE-Heme Registry
Description

To establish and maintain a well-annotated registry (to be called the 'CARE-Heme' Registry) of adults ≥50 years of age with a hematologic malignancy to improve our understanding of this vulnerable population.

Timeframe
5 years
Secondary Outcomes
Measure
To administer a patient reported geriatric assessment and a brief objective physical assessment.
Description

To measure the proportion of patients with overall and domain-specific geriatric impairments, the proportion of patients with Myopenia, and the proportion of patients with frailty.

Timeframe
5 years
Summary

The primary purpose of this protocol is to create a registry of older (≥50 years old) patients with Hematologic Malignancies. Our main objectives include: To understand the prevalence of frailty and geriatric impairments among patients aged ≥50y and above diagnosed with a hematologic malignancy at UAB and to gather information that would lend support for future research in this vulnerable population.

Description

All participants will be invited to participate in a patient reported geriatric assessment questionnaire as well as an objective physical function testing. This includes the Short Physical Performance Battery (SPPB) that evaluates lower extremity performance and muscle strength assessment via hand grip dynamometer. Participants will also complete a 12 item modified version of PRO-CTCAE. This will be administered by trained research staff at the time of study enrollment. Repeat CARE instruments (Follow-up GA questionnaire and Physical Function test) will be administered after the baseline visit to measure changes in patient reported outcomes at 3 months, 6 months, and one year. A one-time blood or saliva sample will be requested and obtained at baseline or a follow-up visit.

Conditions
Multiple Myeloma
Amyloidosis
Plasma Cell Leukemia
Study Contact
Name
Smith Giri, Dr.
Role
Contact
Phone
(205) 638-2120
Email
CAREheme@peds.uab.edu
Locations
Facility

Kirklin Clinic of UAB Hospital
Birmingham, AL 35294
United States

Contacts
Study Contact
Name
Smith Giri, Dr.
Phone
205-638-2120
Email
CAREheme@peds.uab.edu
Role
Contact
Eligibility Criteria

Inclusion Criteria:

* Patients are ≥50 years of age.
* Patients have a biopsy proven diagnosis of Hematologic Malignancy (Multiple Myeloma, AL Amyloidosis, Waldenstrom's Macrogloblunemia, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Myelodysplastic syndromes, Myeloproliferative Neoplasm, Acute/Chronic Myeloid Leukemia, Acute/Chronic Lymphoid Leukemia).
* Patients have appointments at UAB including if they are an inpatient or other clinic locations.

Exclusion Criteria:

* Individuals who are \<50 years old.
* Patients who do not read and/or speak English will not be eligible for this study as many of the questionnaires are not validated in other languages. No exclusions will be made based on gender, ethnicity or race.

Eligibility Minimum Age
50 Years
Sexes Eligible for Study
ALL
Eligibility Std Ages
Adult
Older Adult
Study Population

Patients ≥50 years of age with a diagnosis of any Hematologic Malignancy having an appointment at any participating UAB entity.