Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers: A Prospective G8 Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,401
- 试验地点
- 1
- 主要终点
- Global health status / Quality of Life
研究概览
简要总结
Older patients with cancer constitute a heterogeneous group with varying comorbidity; therefore, geriatric assessment with initial screening is recommended. The Geriatric 8 (G8) has been established as a promising screening tool. Currently, there are no guidelines for oncogeriatric screening in older cancer patients in Denmark. We hypothesize that by screening persons age 70 years or more with newly diagnosed cancer, with the G8, we can assess the prognostic value and identify a subgroup of patients who will benefit from a CGA.
Aims:
- Determine whether Danish cancer patients, with a G8 score of ≤14, experience poorer quality of life (QoL), receive less recommended standard cancer treatment, experience more treatment-related toxicity, stop treatment earlier, and experience shorter survival than patients with a G8 score >14.
- Ascertain whether the standard G8 cut-off score of ≤14 is the most relevant cut-off score, with respect to treatment adherence, treatment-related toxicity, QoL, and survival, when focusing on the older Danish cancer patient population.
- Establish whether the performance and prognostic value of the G8 can be strengthened through the addition of a functional measure, the 30-second chair stand test (30-CST), and/ or the handgrip strength test (HGST).
- Evaluate the prognostic value of the modified Geriatric 8 (mG8)
Methods:
A prospective, descriptive study of all outpatients with newly diagnosed solid tumors at the Department of Oncology, Odense University Hospital, age 70 years or more. Patients will be screened with the G8, mG8, 30-CST, HGST, and QoL questionnaires at baseline with subsequent one-year follow-up, to determine the prognostic value of the G8 and the mG8. An initial two-month pilot study will help determine inclusion rates and highlight necessary practical adjustments to ensure optimal study participation. Baseline characteristics will be compared with descriptive statistics. Our primary endpoint; Global Health status/ QoL (EORTC QLQ-C30 & QLQ-ELD14), and secondary endpoints; treatment adherence, and treatment-related toxicity, will be assessed using logistical regression; while secondary endpoints; overall survival, cancer-specific survival, will be assessed using the Kaplan Meier analysis and Cox proportional hazard models. Post hoc diagnostic performance analysis will be conducted to determine the optimal G8 cut-off and whether functional measures (30-CST and HGST) can enhance screening accuracy.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age ≥70 with solid tumors (not hematological malignancies nor non-melanoma skin cancer) referred to the outpatient clinic at Odense University Hospital for information and/or antineoplastic treatment
- •Patients must be able to give informed consent
- •Patients must be able to speak English or Danish
排除标准
- •Patients who have received antineoplastic treatment for another cancer diagnosis within the past year
- •Patients who have begun chemotherapy or immunotherapy for the referred cancer diagnosis, more than 48 hours prior to the time of consent
- •Patients who have begun other antineoplastic treatment (not endocrine) for the referred cancer diagnosis, more than 7 days prior to the time of consent
结局指标
主要结局
Global health status / Quality of Life
时间窗: 12 months
Global health status will be described using EORTC QLQ-C30
次要结局
- Overall Survival(12 months)
- Performance analysis of the Geriatric 8(12 months)
- Health-related Quality of Life (HRQoL)(12 months)
- Adherence to initial oncologic treatment plan(12 months)
- Cancer-specific Survival(12 months)
研究者
Helena Ditzel
Principal Investigator
Odense University Hospital