NCT05146297

Diversity and Inclusion in Research Underpinning Prevention and Therapy Trials

Diversity and Inclusion in Research Underpinning Trials

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 644 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Cancer
• Liver Cancer
• Prostate Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Clinical trial match-list	Creation and dissemination educational materials designed to inform and empower patients' participation in their cancer treatment including the consideration of clinical trial participation and provide clinical trials' patient navigators (CTPN) to further aid with education about clinical trials.
BEHAVIORAL	Match-list intervention	Providers by intervening at the clinical and systems levels to provide them with tools and processes and informational and practical support to facilitate CT consideration, discussion, and offer to aid with education about clinical trials and facilitate CT consideration at a treatment decision node.

Timeline

• Start date: 2023-04-23
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2021-12-06
• Last updated: 2025-02-20

Locations

3 sites across 1 country: United States