A Randomized Study to Measure and Enhance the Health Related Quality Of Life in Cancer Patients Receiving Immune Checkpoint Modulators
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in Health Related Quality Of Life measured via Functional Assessment of Cancer Therapy - General (FACT-G) at 4 months from baseline, lower scores meaning worse outcome
研究概览
简要总结
The ME-Q study aims to validate a patient reported outcome tool called FACT-ICM, which measures health related quality of life (HRQOL) in patients receiving immune checkpoint modulator (ICM) therapy. In addition, this trial seeks to answer if HRQOL can be improved by monitoring and managing patient symptoms whilst they are treated with ICMs.
详细描述
Immunotherapy has revolutionized cancer care by extending survival, but with a unique set of toxicities known as immune-related adverse events (irAEs), less is known about impact of ICMs on HRQOL.
The ME-Q trial will produce two major innovations: 1) the first validated tool to measure HRQOL in patients on ICMs that can be used in clinical trials and routine clinical care; and 2) a system to monitor and manage patient symptoms on ICMs which can enhance health care delivery for these cancer patients.
ME-Q will randomize patients who are treated with standard of care ICMs to either a monitoring arm developed specifically for this trial or the usual care arm, which is currently how they are managed. All participants will respond to HRQOL questionnaires of which FACT-ICM is a core component. A study nurse will review and manage responses which indicate new or worsening symptoms for those in the monitoring arm. The nurse will contact the patient via telephone or video teleconferencing to conduct a clinical assessment and develop a management plan following irAEs management guidelines. We hypothesize that patients on the monitoring arm will have better HRQOL, longer overall survival, fewer presentations to the emergency department and less hospital admissions than the usual care arm.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with advanced, incurable solid tumors
- •Eligible for immunotherapy (monotherapy or combination ICM)
- •Life expectancy ≥ 6 months
- •ECOG PS 0-3
- •Fluent in English
- •Able to provide informed consent
- •Able to complete questionnaires using digital device or web based application
排除标准
- •Participation in a therapeutic clinical trial testing anticancer therapies
- •Receiving adjuvant immunotherapy
结局指标
主要结局
Change in Health Related Quality Of Life measured via Functional Assessment of Cancer Therapy - General (FACT-G) at 4 months from baseline, lower scores meaning worse outcome
时间窗: Baseline; 4 months
次要结局
- Validity testing of FACT-ICM using Pearson or Spearman correlations between toxicity subscale and FACT-G components of the FACT-ICM and FACT-G scores(Baseline; Up to 45 months)
- Overall survival at 1 year and 2 years(1 year; 2 years)
- Time to first Emergency Department visit and time to first hospitalization(Up to 45 months)
- Time on ICM therapy and time to subsequent therapy(Up to 45 months)
- Evaluate quality adjusted survival(Baseline; Up to 45 months)
- Adherence rate and completion rate of FACT-ICM(Up to 45 months)