Aging and Frailty Study

Aging Biomarkers, Geriatric Assessment and Electronic Frailty Index (AGE)

The purpose of this research study is to compare methods to help personalize the prediction of chemotherapy side effects for older adults and to evaluate whether chemotherapy causes changes in the body that are associated with aging.

Study Overview

• Status: Completed
• Conditions: Frailty; Aging; Effects of Chemotherapy
• Intervention / Treatment: Other: Geriatric Assessments and Frailty Indices

Detailed Description

Primary Objective: Describe mean and variation of the electronic frailty index-cancer, geriatric measures, patient reported outcomes, and biomarkers of aging of chemotherapy, and their change.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Eligible participants will be identified by oncology providers, EPIC reports, or through screening of clinic schedules by the Cancer Control Survivorship Disease Oriented Team Clinical Trial Coordinator or research nurse

Description

Inclusion Criteria:

• Age 65 years and older
• Planned to initiate a new chemotherapy regimen
• Solid tumor malignancy of any stage or lymphoma
• Any performance status
• Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
• Life expectancy of ≥3 months

Exclusion Criteria:

• Initiating biologic, endocrine or immunotherapy only.
• Hematologic malignancy other than lymphoma.
• Concurrent radiation therapy.
• Planned inpatient chemotherapy.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

AGE Participants; Participants aged 65 and older with diagnosis of solid tumor malignancy or lymphoma and planned to start a new chemotherapy regimen in the outpatient setting

Other: Geriatric Assessments and Frailty Indices; Eligible and consented subjects will undergo a baseline assessment prior to chemotherapy initiation inclusive of geriatric/frailty assessments, patient reported outcomes and blood samples for biomarkers of aging. Assessment measures and blood samples will be repeated post cycle 1 and 2 of chemotherapy. Toxicity will be recorded from the medical record

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resiliency Administered Assessments - Change of Short Physical Performance Battery (SPPB)	The SPPB will be used to assess lower extremity physical function (a short walk of 4 meters, timed repeated chair stands and balances tests). Each task is scored ranging from 0-4 (0 = unable to complete; 4 = highest performance level) with the total sum score range from 0-12. Lower scores indicate increased risk of disability, hospitalization and worse survival among older adults with and without cancer.	At baseline, 3 months and 6 months after chemotherapy
Resiliency Administered Assessments - Change of Grip Strength	Grip strength in both hands will be measured using an adjustable, hydraulic grip strength dynamometer. Two trials will be conducted for each hand. Frailty by this criterion is defined by grip strength cutoffs which are dependent upon both gender and body mass index.	At baseline, 3 months and 6 months after chemotherapy
Resiliency Administered Assessments - Change of Blessed Orientation Memory and Concentration Test (BOMC)	A 6 item test that provides a measure of cognition. For items to 1 to 3 the response is either correct (score = 0) or incorrect (score = 1). For items 4 to 6, one point is added for each error (items 4 and 5 maximum error = 2; item 6 maximum error = 5). Maximum score = 28. Participants with scores ≥ 11 will receive further evaluation or intervention as deemed medically appropriate by the treating physician.	At baseline, 3 months and 6 months after chemotherapy
Change of Electronic Frailty Index and Cancer Score/Category	Measures collected from the resiliency assessments (Short Physical Performance Battery, Grip Strength, Blessed Orientation Memory and Concentration Test) will be used to calculate the Fried Frailty Index (FFI) to assess frailty. Scores will be anchored to the date of each assessment time point (i.e., baseline visit, follow-up visits). Each data element will be scored from 0 to 1 and the mean will be computed to calculate the overall score. Some data elements (e.g., comorbidities) will be coded as absent or present (0 or 1) and some (e.g., body mass index) will be assigned a score that ranges from 0 to 1. The higher score indicates a higher frailty of the participant.	At baseline, 3 months and 6 months after chemotherapy
Change in Patient Reported Outcomes Measurement - PROMIS 29	Measures collected from this is a 29-item self-reported measure including 4 items each for the following domains: physical function, anxiety, depression, fatigue, sleep disturbance, social function, and pain interference; plus 1 item measuring average pain intensity and cognition. Scoring is based on a 1-5 point Likert scale (1 = very often; 5 = never). Items are summed to create a total score that ranges from 6-30 and lower scores indicate greater self-reported difficulty.	At baseline, 3 months and 6 months after chemotherapy
Change of Biomarkers of Aging Observed During Study Intervention	Investigators will measure targeted panels of blood-based biomarkers including but not limited to serum Interleukin-6, tumor necrosis factor receptors, growth differentiating factor 15, and cystatin C.	At baseline, 3 months and 6 months after chemotherapy
Number of Incidences of Toxicity - Grades 2 to 5 Related to Standard of Care Chemotherapy	Grade 2 to 5 incidences of toxicities will be recorded and measured using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.	Up to 6 months after chemotherapy
Number of Documented Dose Reductions During Chemotherapy	Participants that have the chemotherapy doses reduced during treatment will be documented.	Up to 6 months after chemotherapy
Number of Dose Delays During Chemotherapy	Dose delays greater than three days from planned treatment will be documented.	Up to 6 months after chemotherapy
Number of Early Discontinuations of Chemotherapy	Participants that have chemotherapy discontinued prior to anticipated completion of treatment will be documented.	Up to 6 months after chemotherapy
Number of Unplanned Hospitalizations	Participants that required unplanned hospitalizations will be documented.	Up to 6 months after chemotherapy
Overall Survival	Participants will be followed after completion of chemotherapy for survival status.	Up to 6 months after chemotherapy

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Heidi Klepin, MD, MS, Wake Forest Baptist Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Actual): June 13, 2025
• Study Completion (Actual): June 13, 2025

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): March 7, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: IRB00080711; WFBCCC 04721 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No