Diversity and Inclusion in Research Underpinning Prevention and Therapy Trials (DISRUPT)

Mount Sinai Health System

Status: Enrolling

Conditions: Breast Cancer; Prostate Cancer; Liver Cancer

Treatments: Behavioral: Match-list intervention; Behavioral: Clinical trial match-list

Study type: Interventional

Funder types: Other

Identifiers

NCT05146297

GCO 21-0012

Details and patient eligibility

About

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.

Enrollment: 644 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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644 participants in 2 patient groups

Patient Participants

Active Comparator group

Description:

Patients with invasive breast, prostate or liver cancer, who face a treatment decision

Treatment:

Behavioral: Clinical trial match-list

Physician Participants

Active Comparator group

Description:

Oncologists, and advanced practitioners caring for patients with breast, prostate, liver cancer including medical, surgical, radiation oncologists, interventional radiologists, urologists \& hepatologists

Treatment:

Behavioral: Match-list intervention