Development and Validation of a Health-related Quality of Life Instrument: Functional Assessment of Cancer Therapy - Immune Checkpoint Modulators, an Investigator Initiated Study (FACT-ICM).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Confirmatory factor analysis of FACT-ICM PRO tool variables compared to content analysis and qualitative descriptives of patient focus groups and interviews in target group
研究概览
简要总结
This study aims to develop a health related quality of life (HRQOL) patient reported outcome (PRO) for patients receiving immune checkpoint modulator (ICM) therapy. This instrument could be used to in clinical trials to evaluate HRQOL for patients treated with novel ICMs and ICM combinations that might ultimately influence decisions about regulatory approval, as well as improved understanding of chronic treatment effects on patient well-being, understanding reasons for treatment non-adherence, and developing strategies to improve adherence and evaluating clinical outcomes.
详细描述
Immune Checkpoint Modulators (ICMs) are associated with significant adverse events. Currently there are no validated patient reported outcome (PRO) tools to assess health related quality of life (HRQOL) specifically in patients receiving ICMs. HRQOL is a multidimensional concept of a patient's perceived well-being that can be affected by disease and treatment. There is an urgent need to assess the impact of ICMs on HRQOL, to better understand the balance between efficacy and toxicity with these agents.
This study aims to develop a health related quality of life (HRQOL) patient reported outcome (PRO) for patients receiving immune checkpoint inhibitor (ICM) therapy (FACT-ICM). The core domains of the FACT-ICM will include physical, emotional, family and social, and functional well being. In addition, the proposed study will develop a toxicity sub-scale related to resultant toxicities from ICM therapy.
The HRQOL will be developed through focus groups and interviews with patients treated with ICMs, and clinicians treating patients with ICMs, to understand how treatment with ICMs impacts HRQOL, as well as explore general experiences, insights and concerns of those receiving ICM therapies.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient Criteria
- •Cancer diagnosis (any type, advanced or metastatic stage);
- •Treatment with an agent or agents that modulate an immune checkpoint (any line of therapy);
- •Age ≥ 18;
- •English-speaking;
- •ECOG PS 0-3
- •Able to complete questionnaires independently
- •Able to provide informed consent.
- •Completed treatment within a year of enrolment
- •Clinician Criteria
- •Must either treat patients with ICMs or manage side effects of patients treated with ICMs
- •Be able to attend interviews and participate in discussions as part of the study
排除标准
- 未提供
结局指标
主要结局
Confirmatory factor analysis of FACT-ICM PRO tool variables compared to content analysis and qualitative descriptives of patient focus groups and interviews in target group
时间窗: 6 months
次要结局
- Comparison of FACT-ICM scores between pre-defined groups of patients where differences are expected(6 months)
- FACT-ICM change scores from baseline to within 30 days after end of treatment(Baseline, an average of 3 months, and within 30 days after end of treatment)
- Change in MCID values from baseline to within 30 days after end of treatment(Baseline, an average of 3 months, and within 30 days after treatment)
- Change of score for each domain and also the total FACT-ICM score at baseline to 5-14 days for patients with minimal change in status(5-14 days)