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临床试验/NCT05268991
NCT05268991已完成不适用

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

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Resiliency Administered Assessments - Change of Short Physical Performance Battery (SPPB)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Resiliency Administered Assessments - Change of Short Physical Performance Battery (SPPB)

时间窗: At baseline, 3 months and 6 months after chemotherapy

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.

Change of Electronic Frailty Index and Cancer Score/Category

时间窗: At baseline, 3 months and 6 months after chemotherapy

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.

Resiliency Administered Assessments - Change of Grip Strength

时间窗: At baseline, 3 months and 6 months after chemotherapy

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.

Change in Patient Reported Outcomes Measurement - PROMIS 29

时间窗: At baseline, 3 months and 6 months after chemotherapy

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.

Resiliency Administered Assessments - Change of Blessed Orientation Memory and Concentration Test (BOMC)

时间窗: At baseline, 3 months and 6 months after chemotherapy

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.

Change of Biomarkers of Aging Observed During Study Intervention

时间窗: At baseline, 3 months and 6 months after chemotherapy

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.

Number of Incidences of Toxicity - Grades 2 to 5 Related to Standard of Care Chemotherapy

时间窗: Up to 6 months after chemotherapy

Grade 2 to 5 incidences of toxicities will be recorded and measured using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.

Number of Documented Dose Reductions During Chemotherapy

时间窗: Up to 6 months after chemotherapy

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

Number of Dose Delays During Chemotherapy

时间窗: Up to 6 months after chemotherapy

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

Number of Early Discontinuations of Chemotherapy

时间窗: Up to 6 months after chemotherapy

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

Number of Unplanned Hospitalizations

时间窗: Up to 6 months after chemotherapy

Participants that required unplanned hospitalizations will be documented.

Overall Survival

时间窗: Up to 6 months after chemotherapy

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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