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.
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Estimado)
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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.
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: OTHER
Coortes e Intervenções
Grupo / Coorte |
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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. |
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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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Participants With Grade 3 to 5 Chemotherapy-Related Toxicities
Prazo: Up to 12 months
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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
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
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Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
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Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
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Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- G8 and CARG Toxicity in Cancer
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