Diversity and Inclusion in Research Underpinning Prevention and Therapy Trials

NCT05146297 | Recruiting

• 1 other identifier: GCO 21-0012
• Study Type: interventional
• Target: 644
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer; Liver Cancer; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Clinical Trial Accrual

  Change in rates of clinical trial accrual of the total population and BIPOC population.

  from start to the conclusion of recruitment to the clinical trial, average of 2 months

Secondary Outcomes (3)

• 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

Study Arms (2)

Patient Participants

ACTIVE COMPARATOR

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

Behavioral: Clinical trial match-list

Physician Participants

ACTIVE COMPARATOR

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

Interventions

Clinical trial match-list BEHAVIORAL

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.

Patient Participants

Match-list intervention BEHAVIORAL

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.

Physician Participants

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (3)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Herbert Irving Comprehensive Cancer Care Center

New York, New York, 10032, United States

RECRUITING

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

RECRUITING

Related Publications (1)

• Bickell NA, May B, Havrylchuk I, John J, Lin S, Tao A, Yagnik R, Tatonetti NP. Implementation of a rule-based algorithm to find patients eligible for cancer clinical trials. JAMIA Open. 2024 Nov 18;7(4):ooae131. doi: 10.1093/jamiaopen/ooae131. eCollection 2024 Dec.

  PMID: 39559491 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Liver Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Nina Bickell

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radhi Yagnik

CONTACT

212-659-5933; radhi.yagnik@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 6, 2021
• Study Start: April 23, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)