A Phase IV Study of Apricity C.A.R.E. Program for Cancer Adverse Events Rapid Evaluation to Improve Treatment Outcomes of Ethnic/Racial Minority Non-small Cell Lung Cancer (NSCLC) Patients Receiving Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Percent of study patients who experienced treatment delay/discontinuation
研究概览
简要总结
The purpose of this trial is to study the effectiveness of the AprictyRxTM care service to improve treatment outcomes of ethnic/racial minority N.S.C.L.C. patients receiving standard of care immunotherapy, and reduce the frequency of healthcare system interactions.
详细描述
Immune checkpoint inhibitors (I.C.I.) targeting the PD-1/PD-L1 axis have changed the treatment landscape of non-small cell lung cancer (N.S.C.L.C.). After demonstrating improved efficacy and tolerability compared to standard chemotherapy in several large clinical trials, these novel drugs are now F.D.A. approved in multiple treatment settings. With the increase in I.C.I. use, the incidence of immune-related adverse effects (irAEs) has also risen, occurring in up to 16% of ICI-treated patients. Prompt recognition and timely management are necessary to avert potential poor outcomes from direct toxicity and/or early treatment discontinuation. However, rapid adoption of I.C.I.s may limit healthcare providers' experience and comfort with managing important irAEs. Additionally, existing barriers to access care that disproportionately impact racial and ethnic minority patients may amplify the inability to manage patients on I.C.I.s effectively.
Using technologically-enabled health interventions in a culturally competent manner can improve access to health care resources and reduce health disparities. These platforms need to be optimized at the literacy level of underserved minority communities and can be adapted to meet the community's needs. Recently, technology-enabled services focused on patient-reported outcomes have garnered growing interest in oncology.
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
- •Age≥ 18 years
- •Confirmed NSCLC diagnosis
- •Prescribed treatment with immune-checkpoint inhibitor, including in combination with chemotherapy
- •Ability to understand and the willingness to sign a written informed consent document
- •Self-identification as a member of an ethnic minority or underserved population.
排除标准
- •An individual with presence of any medical, psychological, or social condition that, in the opinion of the investigator would preclude participation in this study.
- •Patients enrolled in other interventional clinical trials at the time of screening will be excluded.
研究组 & 干预措施
Control Arm
Clinicians will monitor NSCLC patients on ICIs for irAEs as a standard of care using routine practices.
Intervention Arm
Participants are provided with ApricityRx digital solution with pulse oximeters and 24/7 C.A.R.E. (Cancer Adverse event Rapid Evaluation) to monitor and capture ePRO, identify onset or progression of symptoms verified by nurse triage, trigger intervention by the study team.
干预措施: Apricity C.A.R.E. Program for Cancer Adverse events Rapid Evaluation (Other)
结局指标
主要结局
Percent of study patients who experienced treatment delay/discontinuation
时间窗: 2 years
To determine the impact of the the Apricity CARE program on immunotherapy toxicity monitoring for N.S.C.L.C. patients receiving immunotherapy in a highly diverse New York City community. Immune Checkpoint Inhibitor (ICI) treatment delay or discontinuation is defined as a gap between doses of ICI beyond 60 days and/or the initiation of another cancer therapy without evidence of disease progression.
Mean Likert-type scale score
时间窗: 2 years
Two focus group discussions (FGDs), stratified on a Likert-type scale based on the frequency of utilization, to determine factors related to usage of ApricityCare app and utilization of the CARE monitoring service (Run-in phase). To assess factors related to suboptimal and optimal use of the ApricityCare app and the CARE monitoring service, collectively "the Apricity CARE program".
次要结局
- Time to irAE management(2.5 years)
- Percent of study patients who experience a severe irAE (grade 3 or higher).(2.5 years)
- Time to treatment discontinuation with ICI(2.5 years)
- Number of interactions with the care team and utilization(2.5 years)
- Number of interviews/surveys completed(2.5 years)
研究者
Brian Henick, MD
Assistant Professor of Medicine at the Columbia University Medical Center
Columbia University