NCT07646847招募中不适用
I CARE (Immunotherapy Cutaneous Adverse Events REsearch) - A Trial With Diverse Cancer Patients to Determine the Impact of SDoH and Side Effects Navigation Program on Treatment Continuation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Immune Checkpoint Inhibitors/ICI continuation
研究概览
简要总结
The purpose of this study is to find out if the navigation program helps participants manage immunotherapy treatment better than usual care. Investigators will also look at how the navigation program impacts participants' quality of life. Investigators will measure quality of life by having participants complete questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Documentation of Disease
- •o Patient must have pathologically confirmed kidney, bladder, breast, or lung cancer (per EMR)
- •Prior Treatment
- •o Within three weeks (+/- 3 weeks) of starting PD-1 or PD(L)-1 immune checkpoint inhibitors as monotherapy or in combination with other therapies (per EMR)
- •Age ≥ 18 (per EMR)
- •Not Pregnant and Not Nursing (per self-report)
- •At least one essential need (e.g., food, transportation, housing), as determined by the ICCAN Essential Needs Screener (per self-report)
- •Lives in New York metro area, including Long Island, New Jersey, Connecticut, and Pennsylvania (per self-report)
- •Can speak English or Spanish (per self-report)
- •Has no significant psychiatric disturbance sufficient to preclude completion of the assessment measures, interview, or informed consent (i.e., acute psychiatric symptoms which require individual treatment) (per EMR, patient's care team, or study team)
- •Has no presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection (per EMR, patient's care team, or study team)
排除标准
- 未提供
研究组 & 干预措施
I CARE Group
Experimental
Immunotherapy CARE Program
干预措施: Immunotherapy CARE Program (Other)
U&C Group
No Intervention
Enhanced Usual and Customary care and support (U&C)
结局指标
主要结局
Immune Checkpoint Inhibitors/ICI continuation
时间窗: 6 months
Participant ICI appointment and treatment adherence will be documented through chart abstraction (research staff EMR review) at 6 months
次要结局
未报告次要终点
研究者
研究点 (8)
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