Aging and Frailty Study

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• Frailty 1,199

Frailty

1,199 studies on the registry are indexed under Frailty; 430 are open to participants now.

This study's enrollment of 25 is below the median of 223 across 496 observational studies indexed under Frailty.

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Study population

Groups and cohorts

• 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

Interventions

• OtherGeriatric 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

Primary outcomes

1. 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.

   Time frame: At baseline, 3 months and 6 months after chemotherapy

2. 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.

   Time frame: At baseline, 3 months and 6 months after chemotherapy

3. 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.

   Time frame: At baseline, 3 months and 6 months after chemotherapy

4. 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.

   Time frame: At baseline, 3 months and 6 months after chemotherapy

5. 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.

   Time frame: At baseline, 3 months and 6 months after chemotherapy

6. 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.

   Time frame: At baseline, 3 months and 6 months after chemotherapy

7. 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.

   Time frame: Up to 6 months after chemotherapy

8. Number of Documented Dose Reductions During Chemotherapy

   Participants that have the chemotherapy doses reduced during treatment will be documented.

   Time frame: Up to 6 months after chemotherapy

9. Number of Dose Delays During Chemotherapy

   Dose delays greater than three days from planned treatment will be documented.

   Time frame: Up to 6 months after chemotherapy

10. Number of Early Discontinuations of Chemotherapy

    Participants that have chemotherapy discontinued prior to anticipated completion of treatment will be documented.

    Time frame: Up to 6 months after chemotherapy

11. Number of Unplanned Hospitalizations

    Participants that required unplanned hospitalizations will be documented.

    Time frame: Up to 6 months after chemotherapy

12. Overall Survival

    Participants will be followed after completion of chemotherapy for survival status.

    Time frame: Up to 6 months after chemotherapy

Individual participant data

Plan to share: No