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Diversity and Inclusion in Research Underpinning Prevention and Therapy Trials

Diversity and Inclusion in Research Underpinning Trials

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05146297
Acronym
DISRUPT
Enrollment
585
Registered
2021-12-06
Start date
2023-04-23
Completion date
2026-04-15
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Liver Cancer, Prostate Cancer

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.

Interventions

BEHAVIORALClinical 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.

BEHAVIORALMatch-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.

Sponsors

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Clinical Trial Accrualfrom start to the conclusion of recruitment to the clinical trial, average of 2 monthsChange in rates of clinical trial accrual of the total population and BIPOC population.

Secondary

MeasureTime frameDescription
Number of physicians agree to usefulness of the match listsat 6 months post intervention implementationNumber of physicians who find the match lists useful to inform decision-making and clinical trial participation.
Patient Post-intervention Survey2 weeks post intervention implementationSurvey 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.
Physician Post -intervention surveyat 6 months post intervention implementationSurvey 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORNina Bickell

Icahn School of Medicine at Mount Sinai

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026