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临床试验/NCT06553378
NCT06553378尚未招募不适用

The GOS-Frail (Geriatric Oncology Supportive Care for Frail Older Adults With Cancer) Study

Tan Tock Seng Hospital1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
154
试验地点
1
主要终点
EuroQoL-5 Dimension (EQ5D-5L)

研究概览

简要总结

Background Cancer is more prevalent in older adults, but most cancer treatment trials have mainly involved young and healthy subjects. Among geriatric syndromes, frailty is a significant risk factor for negative outcomes such as treatment delays, discontinuation, and treatment-related side effects, as well as functional decline and poor survival. Research has shown that geriatric assessment with appropriate intervention can improve these outcomes, although the impact may be influenced by the inclusion of patients receiving palliative-intent treatment. Supportive care focuses on symptom assessment and treatment to enhance treatment tolerance and quality of life. To date, there have been no studies examining the combined benefits of geriatric oncology and supportive care clinics. We conducted a pilot study called Geriatric Oncology Supportive Clinic for Elderly (GOSPEL), which demonstrated an improved quality of life for older adults with curable cancer. Based on these results, we developed an enhanced care model.

Aim The study GOS-Frail aims to assess the effect of an integrated Geriatric Oncology Supportive Clinic on the quality of life of older adults with cancer receiving curative-intent chemotherapy and/or radiotherapy at 1 month.

Methods The GOS-Frail study is a multi-centre, open-label, parallel-arm, randomized controlled trial conducted in the specialist outpatient clinics of two university-affiliated tertiary care hospitals. 154 adults aged 65 and above, diagnosed with solid organ cancer and planned for curative-intent chemotherapy and/or radiotherapy, and with a clinical frailty scale score of 4 and above, will be recruited. Subjects will be randomized to either attend a geriatric oncology supportive clinic or receive frailty education material. Quality of life questionnaires will be administered at baseline, 2 weeks, and 1, 3, 6, and 12 months from treatment initiation.

Hypothesis:

The GOS-Frail study investigates on the role of a synergistic geriatric oncology and supportive model of care in improving quality of life in older adults undergoing curative-intent cancer treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Diagnosis of solid organ cancer
  • Plan for curative-intent chemotherapy and/or radiotherapy
  • Clinical Frailty Scale (CFS) score ≥ 4,

排除标准

  • Evaluation by Geriatric or Palliative Medicine in the previous 6 months.

结局指标

主要结局

EuroQoL-5 Dimension (EQ5D-5L)

时间窗: 1 month

EuroQoL-5 Dimension (EQ5D-5L)

次要结局

未报告次要终点

研究者

发起方
Tan Tock Seng Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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