Breast CancerDISRUPTNCT05146297
Diversity and Inclusion in Research Underpinning Prevention and Therapy Trials
A study testing Clinical trial match-list and Match-list intervention in people with Breast Cancer and Liver Cancer, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Breast Cancer, Liver Cancer, Prostate Cancer
- What is being tested?
- Clinical trial match-list and Match-list intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 585 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Apr 2023to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Herbert Irving Comprehensive Cancer Care Center
New York, New York, 10032
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: 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.
- Conditions
- Breast Cancer, Liver Cancer, Prostate Cancer
- Being tested
- Clinical trial match-list, Match-list intervention
- Medical subject headings
- Breast Neoplasms, Liver Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical trial match-listBehavioural
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 interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient Participants | Active comparator | Patients with invasive breast, prostate or liver cancer, who face a treatment decision Receives: 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 Receives: Behavioral: Match-list intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Trial Accrual
Change in rates of clinical trial accrual of the total population and BIPOC population.
Measured: 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
Number of physicians who find the match lists useful to inform decision-making and clinical trial participation.
Measured: at 6 months post intervention implementation
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.
Measured: 2 weeks post intervention implementation
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.
Measured: at 6 months post intervention implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start23 Apr 2023
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 585 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Bickell, Icahn School of Medicine at Mount Sinai
- Investigators
- Nina Bickell, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146297
- Sponsor's protocol ID
- GCO 21-0012
- Acronym
- DISRUPT
- Status last verified
- May 2026
- First submitted
- 22 Nov 2021
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: undecided
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 at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diversity and Inclusion in Research Underpinning Trials
- ClinicalTrials.gov ID
- NCT05146297
- Acronym / sponsor ID
- DISRUPT / GCO 21-0012
- Conditions
- Breast Cancer, Liver Cancer, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 585 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 23 Apr 2023 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Participants | Active comparator | Behavioral: Clinical trial match-listPatients with invasive breast, prostate or liver cancer, who face a treatment decision |
| Physician Participants | Active comparator | Behavioral: Match-list interventionOncologists, and advanced practitioners caring for patients with breast, prostate, liver cancer including medical, surgical, radiation oncologists, interventional radiologists, urologists \& hepatologists |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical trial match-listCreation 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. | Behavioural | Patient Participants |
| Match-list interventionProviders 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. | Behavioural | Physician Participants |
Primary outcome
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.
3 secondary outcomes
Number of physicians agree to usefulness of the match lists
Time frame: at 6 months post intervention implementation
Patient Post-intervention Survey
Time frame: 2 weeks post intervention implementation
Physician Post -intervention survey
Time frame: at 6 months post intervention implementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Derived from this study: PubMed 39559491Bickell 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.
- Individual participant dataSharing planned: No. undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Bickell principal investigator
Icahn School of Medicine at Mount Sinai
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical trial match-list and Match-list intervention in people with Breast Cancer and Liver Cancer, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Trial Accrual (time frame: from start to the conclusion of recruitment to the clinical trial, average of 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05146297, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.