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NCT05146297 | Recruiting | Breast Cancer


Diversity and Inclusion in Research Underpinning Prevention and Therapy Trials
Sponsor:

Icahn School of Medicine at Mount Sinai

Information provided by (Responsible Party):

Nina Bickell

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.

Condition or disease

Breast Cancer

Liver Cancer

Prostate Cancer

Intervention/treatment

Clinical trial match-list

Match-list intervention

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 1200 participants
Masking : None (Open Label)
Primary Purpose : Health Services Research
Official Title : Diversity and Inclusion in Research Underpinning Trials
Actual Study Start Date : December 24, 2022
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : April 2025
Arm Intervention/treatment

Active Comparator: Patient Participants

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

Behavioral: Clinical trial match-list

Active Comparator: Physician Participants

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

Behavioral: Match-list intervention

Ages Eligible for Study: 21 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

Diversity and Inclusion in Research Underpinning Prevention and Therapy Trials

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Diversity and Inclusion in Research Underpinning Prevention and Therapy Trials

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Locations


Recruiting

United States, New York

Albert Einstein College of Medicine

Bronx, New York, United States, 10461

Recruiting

United States, New York

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Recruiting

United States, New York

Herbert Irving Comprehensive Cancer Care Center

New York, New York, United States, 10032

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