Integrating Geriatric 8 (G8) Screening and Cancer and Age Research Group (CARG) Toxicity Assessment Score Into Routine Care for Older Adults With Cancer
Integrating Geriatric 8 (G8) Screening and Cancer and Age Research Group (CARG) Toxicity Assessment Score Into Routine Oncology Care for Older Adults With Cancer
This study evaluates whether using specialized geriatric screening and toxicity prediction tools can help oncologists personalize chemotherapy dosing and reduce severe side effects in older adults with solid cancers.
Older adults with cancer have diverse levels of physical resilience and functional reserve that standard oncologic performance scores often miss. Consequently, uniform standard chemotherapy dosing can lead to severe, life-threatening toxicities, unplanned hospitalizations, or early treatment discontinuation.
In this prospective-retrospective comparative study, patients aged 65 years and older who are starting chemotherapy are prospectively evaluated using the Geriatric 8 (G8) screening tool. Patients identified as vulnerable (G8 score ≤ 14) undergo a Comprehensive Geriatric Assessment (CGA) across functional, nutritional, cognitive, and psychological domains. In addition, all prospective participants are evaluated using the Cancer and Age Research Group (CARG) toxicity tool to calculate their risk of severe side effects. Chemotherapy doses are risk-adapted based on CARG scores:
- Low Risk: Standard chemotherapy dose
- Intermediate Risk: 20% dose reduction
- High Risk: 50% dose reduction
Participants are followed every 3 months for 1 year to evaluate treatment tolerance, adherence, tumor response, and survival. These outcomes will be compared against a historical retrospective cohort of older patients with solid tumors who received standard-dose chemotherapy without G8 screening or CARG toxicity risk stratification.
調査の概要
状態
研究の種類
入学 (推定)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Older adult patients (aged 65 years and older) with confirmed solid malignancies who are scheduled to initiate chemotherapy at the Clinical Oncology Department, Assiut University Hospitals, Faculty of Medicine. The population comprises prospectively presenting patients undergoing oncogeriatric screening and risk-adapted chemotherapy, alongside a historical control cohort of comparable older patients previously treated at the same center.
説明
Inclusion Criteria:
- Age 65 years or older
- Confirmed diagnosis of any solid malignancy
- Scheduled to initiate cytotoxic chemotherapy
Exclusion Criteria:
- Hematological malignancies (e.g., leukemia, lymphoma)
- Treatment plans consisting exclusively of non-chemotherapy modalities (e.g., endocrine therapy, immunotherapy monotherapy, or radiotherapy alone)
- Incomplete or missing medical records (applicable to the retrospective historical control cohort)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：OTHER
コホートと介入
グループ/コホート |
|---|
|
Prospective G8/CARG-Guided Cohort
Older adult patients (aged ≥ 65 years) with solid malignancies prospectively evaluated prior to chemotherapy using the Geriatric 8 (G8) screening tool (scores ≤ 14 trigger a Comprehensive Geriatric Assessment) and the Cancer and Age Research Group (CARG) toxicity calculator. Chemotherapy dosing is risk-adapted: standard dose for low risk (CARG 0-5), a 20% dose reduction for intermediate risk (CARG 6-9), and a 50% dose reduction for high risk (CARG ≥ 10). Patients undergo periodic clinical, geriatric, and radiological evaluations every 3 months for 1 year. |
|
Retrospective Historical Control Cohort
A historical control cohort of older adult cancer patients (aged ≥ 65 years) with comparable solid malignancies treated with standard-dose chemotherapy prior to the institutional implementation of routine G8 screening and CARG toxicity risk assessment. Treatment-related toxicities, treatment completion, tumor response, and survival outcomes are collected retrospectively from medical records. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Participants With Grade 3 to 5 Chemotherapy-Related Toxicities
時間枠：Up to 12 months
|
Percentage of participants who experience at least one severe, life-threatening, or fatal (Grade 3, 4, or 5) adverse event related to chemotherapy. Toxicities are evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) criteria. |
Up to 12 months
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- G8 and CARG Toxicity in Cancer
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