Cancer and Aging Resilience Evaluation in Older Adults With Hematologic Malignancies: The CARE-Heme Registry

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Recruiting
CT.gov ID
NCT05556928
Collaborator
(none)
5,000
1
53.4
93.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cancer and Aging Resilience Evaluation in Older Adults With Hematologic Malignancies: The CARE-Heme Registry
    Actual Study Start Date :
    Jul 21, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Create the CARE-Heme Registry [5 years]

      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.

    Secondary Outcome Measures

    1. To administer a patient reported geriatric assessment and a brief objective physical assessment. [5 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kirklin Clinic of UAB Hospital Birmingham Alabama United States 35294

    Sponsors and Collaborators

    • University of Alabama at Birmingham

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Smith Giri, Principal Investigator, University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT05556928
    Other Study ID Numbers:
    • IRB-300005372
    First Posted:
    Sep 27, 2022
    Last Update Posted:
    Sep 27, 2022
    Last Verified:
    Sep 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 27, 2022