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CompletedNCT05146297DISRUPTUpdated May 19, 2026

Diversity and Inclusion in Research Underpinning Prevention and Therapy Trials

An interventional study of Clinical trial match-list and Match-list intervention in Breast Cancer, Liver Cancer and Prostate Cancer, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 3 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.

Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
585
Allocation
Non-randomized
Ages
21 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Breast Cancer
  • Liver Cancer
  • Prostate Cancer
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 585 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.

Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
585 participants (actual)

Study arms

  • 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

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.

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What researchers measure

Primary outcomes

  1. Change in Clinical Trial Accrual

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

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

Secondary outcomes

  1. 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.

    Time frame: at 6 months post intervention implementation

  2. 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.

    Time frame: 2 weeks post intervention implementation

  3. 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.

    Time frame: at 6 months post intervention implementation

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Study locations

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

Publications

  • 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. PubMed 39559491 ↗

Study documents

  • Informed consent form · Oct 16, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05146297
Lead sponsor
Icahn School of Medicine at Mount Sinai
Responsible party
Nina Bickell (Professor, Icahn School of Medicine at Mount Sinai) — Principal investigator
First posted
Dec 6, 2021
Start date
Apr 23, 2023
Primary completion
Apr 15, 2026
Completion
Apr 15, 2026
Last update
May 19, 2026

Study contacts

Nina Bickell
principal investigator · Icahn School of Medicine at Mount Sinai

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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