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

May 15, 2026 updated by: Nina Bickell, Icahn School of Medicine at Mount Sinai

Diversity and Inclusion in Research Underpinning Trials

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

585

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Care Center
      • The Bronx, New York, United States, 10461
        • Albert Einstein College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinical Trial Accrual
Time Frame: from start to the conclusion of recruitment to the clinical trial, average of 2 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of physicians agree to usefulness of the match lists
Time Frame: at 6 months post intervention implementation
Number of physicians who find the match lists useful to inform decision-making and clinical trial participation.
at 6 months post intervention implementation
Patient Post-intervention Survey
Time Frame: 2 weeks post intervention implementation
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
Physician Post -intervention survey
Time Frame: at 6 months post intervention implementation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Nina Bickell, Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2023

Primary Completion (Actual)

April 15, 2026

Study Completion (Actual)

April 15, 2026

Study Registration Dates

First Submitted

November 22, 2021

First Submitted That Met QC Criteria

December 3, 2021

First Posted (Actual)

December 6, 2021

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 21-0012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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