Diversity and Inclusion in Research Underpinning Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 585
- 试验地点
- 3
- 主要终点
- Change in Clinical Trial Accrual
研究概览
简要总结
This proposal brings together multidisciplinary teams from four New York City institutions charged with reducing cancer disparities that affect approximately two million people residing in some of the most diverse and underserved communities in the United States. The intent of this collaborative research is captured by its acronym, DISRUPT: Diversity & IncluSion in Research Underpinning Prevention & Therapy Trials. To disrupt the norms that maintain heightened risk and poorer outcomes experienced by BIPOC, the research team propose three integrated and synergistic aims to improve diversity and inclusion in CTs through disruptive approaches at the community (Aim 1), provider, system and patient (Aim 2), and basic and translational scientist levels (Aim 3). All three aims focus on metrics for changing norms reified in institutional policies and established practice that will provide essential evidence to translate and scale these changes to institutions and networks involved in cancer treatment research. In Aim 1, the research team will partner with local organizations to formulate and disseminate new norms regarding cancer care and research and diffuse these new norms throughout the community via community organizations and Health Ambassadors bringing a different vantage point on CTs, raising awareness and increasing demand for access to cancer research. In Aim 2, the research team will create an electronic approach to identify key clinical characteristics of patients and trials and match patients and trials and bring these data to patients and their physicians at the time of key decisions. In Aim 3, the research team will provide and integrate essential experiential training in diversity, social determinants of health and the importance of conducting community-relevant work into basic and translational science training. This DISRUPT proposal provides the foundation to disrupt norms about cancer clinical trials in our communities, delivery systems and scientific research enterprises.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients >21 years of age with invasive breast, lung or liver cancer, who face a treatment decision
- •patients of doctors who have consented to participate
- •able to give consent and speak either English or Spanish
- •For provider recruitment, oncologists, and advanced practitioners caring for patients with breast, lung, liver cancer including medical and surgical oncologists, interventional radiologists & hepatologists will be eligible
排除标准
- •Patients who are unable to give consent
- •unable to understand English or Spanish
- •lack of invasive breast/liver cancer
- •those who do not face an imminent treatment decision
研究组 & 干预措施
Patient Participants
Patients with invasive breast, prostate or liver cancer, who face a treatment decision
干预措施: Clinical trial match-list (Behavioral)
Physician Participants
Oncologists, and advanced practitioners caring for patients with breast, prostate, liver cancer including medical, surgical, radiation oncologists, interventional radiologists, urologists & hepatologists
干预措施: Match-list intervention (Behavioral)
结局指标
主要结局
Change in Clinical Trial Accrual
时间窗: from start to the conclusion of recruitment to the clinical trial, average of 2 months
Change in rates of clinical trial accrual of the total population and BIPOC population.
次要结局
- Number of physicians agree to usefulness of the match lists(at 6 months post intervention implementation)
- Patient Post-intervention Survey(2 weeks post intervention implementation)
- Physician Post -intervention survey(at 6 months post intervention implementation)
研究者
Nina Bickell
Professor
Icahn School of Medicine at Mount Sinai