Clinical trial NCT05146297: Diversity and Inclusion in Research Underpinning Prevention and Therapy Trials
Official title: Diversity and Inclusion in Research Underpinning Trials
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Liver Cancer
Prostate Cancer
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 644
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Clinical Trial Accrual
timeFrame: from start to the conclusion of recruitment to the clinical trial, average of 2 months
Secondary outcomes:
measure: Number of physicians agree to usefulness of the match lists
timeFrame: at 6 months post intervention implementation
measure: Patient Post-intervention Survey
timeFrame: 2 weeks post intervention implementation
measure: Physician Post -intervention survey
timeFrame: at 6 months post intervention implementation
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: NYC
country: United States
facility: Herbert Irving Comprehensive Cancer Care Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Nina Bickell
role: PRINCIPAL_INVESTIGATOR
References: