Impact of Geriatric assessment- based intervention on Health-Related Quality of life of older patients with cancer
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- AIIMS
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Change in HRQoL by Global health status scale of EORTC QLQ C-30
研究概览
简要总结
Indian population is aging with increased percentage of older age population. This further increases the prevalence of chronic, non-communicable diseases, of which malignancies are one. Two important aims of treatment in older patients with cancer are increasing survival and improving their health-related quality of life (HRQoL). The management of older cancer population is challenging in view of increased number of comorbidities and increased age-related issues, which can be assessed by comprehensive geriatric assessment. Previous studies have shown that with time HRQoL changes in these patients and baseline quality of life (QoL) parameters are better prognostic markers than other clinical variables. It has been seen in multiple studies that multidisciplinary interventions improve HRQoL scores, but other studies have shown conflicting results with conflicting effect on survival. While patient’s communication and satisfactions seemed to improve, with these interventions. But these interventions and their results were not uniform in the studies.
With the hypothesis that geriatric assessment (GA) based personalized interventions will improve the HRQoL of the older patients with cancer, this study has been planned. Other objectives would be to observe the impact of these interventions on survival, toxicity of the treatment, patient satisfaction, muscle mass and strength, and molecular levels. This study would be done in treatment naïve patients with solid malignancies to maintain homogeneity. In this prospective randomized two group comparative study, patient would be divided in two groups, of which one would be given GA based personalized interventions by the multidisciplinary team (planned by the investigator) and then would be send to the medical oncology team for standard of care treatment. While the other group would undergo geriatric assessment and with the results would be send to medical oncology team for standard of care, and further referrals to super-specialty would be decided by treating oncologist. These patients would be followed for one year to observe their survival, patient satisfaction, treatment toxicity, muscle mass and strength and change in biomarker levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 65.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients age more than 65 years with a diagnosis of solid malignant neoplasm of any stage, ECOG 0-2, able to give written informed consent, treatment naïve older patients with cancer.
排除标准
- •Patient denying participation, ECOG 3 and 4, hematological malignancies.
结局指标
主要结局
Change in HRQoL by Global health status scale of EORTC QLQ C-30
时间窗: At baseline and 6 months
次要结局
- change in other HRQoL parameters on EORTC QLQ C-30 & FACT-G at 3 & 6 months(Overall survival at 1 year)
