Diversity and Inclusion in Research Underpinning Prevention and Therapy Trials

Breast Cancer Clinical Trial

— DISRUPT  

Official title:

Diversity and Inclusion in Research Underpinning Trials

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05146297
• Other study ID #: GCO 21-0012
• Status: Recruiting
• Phase: N/A
• Start date: December 24, 2022
• Est. completion date: April 2025

Study information

• Verified date: January 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Radhi Yagnik
• Phone: 212-659-5933
• Email: radhi.yagnik[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Liver Cancer
• Liver Neoplasms
• Prostate Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York
United States	Herbert Irving Comprehensive Cancer Care Center	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of physicians agree to usefulness of the match lists	Number of physicians who find the match lists useful to inform decision-making and clinical trial participation.	at 6 months post intervention implementation
Secondary	Patient Post-intervention Survey	Survey is not summed: there is no scoring or a scale for survey. Questions will be looked at individually for statements related to patient level barriers that influenced CT discussions and offers. Some answers are yes/no while others may multiple choices.	2 weeks post intervention implementation
Secondary	Physician Post -intervention survey	Survey is not summed: there is no scoring or a scale for survey. Questions will be looked at individually for statements related to patient, physician, and system level barriers that influenced CT discussions and offers. Some answers are yes/no while others may multiple choices.	at 6 months post intervention implementation