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Trial Title:
Cancer and Aging Resilience Evaluation in Older Adults With Hematologic Malignancies: The CARE-Heme Registry
NCT ID:
NCT05556928
Condition:
Multiple Myeloma
Amyloidosis
Plasma Cell Leukemia
Conditions: Official terms:
Multiple Myeloma
Hematologic Neoplasms
Leukemia, Plasma Cell
Amyloidosis
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Detailed 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.
Criteria for eligibility:
Study pop:
Patients ≥50 years of age with a diagnosis of any Hematologic Malignancy having an
appointment at any participating UAB entity.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
50 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Kirklin Clinic of UAB Hospital
Address:
City:
Birmingham
Zip:
35294
Country:
United States
Status:
Recruiting
Contact:
Last name:
Smith Giri, Dr.
Phone:
205-638-2120
Email:
CAREheme@peds.uab.edu
Start date:
July 21, 2020
Completion date:
December 31, 2024
Lead sponsor:
Agency:
University of Alabama at Birmingham
Agency class:
Other
Source:
University of Alabama at Birmingham
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05556928