SURGE: Supporting Utility and Representation in Genomics-based Cancer Trial Enrollment (Intervention)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 6
- 主要终点
- Genomic testing uptake
研究概览
简要总结
SURGE aims to increase representation in clinical trial enrollment by addressing barriers to genomic testing, which is increasingly needed to assess precision clinical trial eligibility and access standard precision therapies. The study is an interventional pilot meant primarily to assess the feasibility of the intervention. The intervention is comprised of a patient navigator, text message questionnaire, and informational video.
详细描述
Supporting Utility and Representation in Genomics-based cancer trial Enrollment (SURGE) is a multimodal intervention to address medical literacy and unmet social determinants of health (SDoH) needs as barriers to tumor somatic genomic testing consent among historically underrepresented patients (HUP) diagnosed with advanced solid or hematologic malignancies as a prerequisite to precision therapies and/or clinical trial eligibility. Our key hypothesis is that video-based education with or without 1:1 patient navigation will address medical literacy and unmet SDoH barriers, supporting HUP decision-making about genomic tumor consent. We will conduct a type 1 hybrid implementation effectiveness study among a cohort of HUP seeking medical oncology care at two academic and two community practice sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Adult (age 18 years or older)
- •Scheduled for a new patient consultation
- •Suspected or confirmed advanced malignancy (requiring active treatment)
- •DFCI patient at Longwood/Chestnut Hill, DFCI satellite at BMC-Brighton (formerly St. Elizabeth's Medical Center), DFCI satellite at Foxborough, or DFCI satellite at Merrimack Valley
排除标准
- •Malignancy or former malignancy that requires only surveillance
- •Not continuing care at a participating DFCI site
- •Speaks a language other than English, Spanish, Haitian Creole, Russian, Portuguese, Arabic, or Traditional Chinese
- •Unable to provide consent
研究组 & 干预措施
Arm B (informational video)
Participants will complete screening questionnaire via text or by phone to establish baseline awareness and interest in clinical trials and then randomized to the SURGE intervention where they will receive:
- Informational Video
干预措施: SURGE (Behavioral)
Arm A (standard of care)
Participants will complete screening questionnaire via text or by phone to establish baseline awareness and interest in clinical trials and then randomized to Standard of Care (SOC) and receive:
- Standard of Care
Arm C (informational video and patient navigation)
Participants will complete screening questionnaire via text or by phone to establish baseline awareness and interest in clinical trials and then randomized to the SURGE intervention where they will receive:
- Informational Video and Patient Navigation
干预措施: SURGE (Behavioral)
结局指标
主要结局
Genomic testing uptake
时间窗: Up to 90 days of enrollment
Intervention impact on rate of uptake of genomic testing
次要结局
- Patient interaction with the intervention(Up to 30 days of enrollment)
- Acceptability of questionnaire modality(Up to 30 days of enrollment)
研究者
Nadine Jackson, MD, MPH
Sponsor-Investigator
Dana-Farber Cancer Institute