Diversity and Inclusion in Research Underpinning Prevention and Therapy Trials

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

644 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-23

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Accountability for Cancer Care Through Undoing Racism and Equity

NCT01954641

Breast Cancer Lung Cancer

COMPLETED NA

Intervention for Rural Cancer Patients

NCT05091593

Depression Quality of Life Social Support +2 more

WITHDRAWN NA

Improving Survivorship Among Minority Cancer Dyads

NCT04685551

Cancer Breast Cancer Colon Cancer +2 more

WITHDRAWN NA

Driving Inclusivity, Validity, and Equity in Research Through Strategic Engagement (DIVERSE)

NCT06469307

Blood Cancer Leukemia

RECRUITING NA

Evaluation of Cancer Care Coordination in the National Cancer Institutes Community Cancer Center Programs

NCT01346280

Non-Small Cell Lung Cancer (Stage III) Colon Cancer (Stage II &Amp; III) Rectal Cancer (Stage III)

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Liver Cancer Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient Participants

Patients with invasive breast, prostate or liver cancer, who face a treatment decision

Group Type ACTIVE_COMPARATOR

Clinical trial match-list

Intervention Type BEHAVIORAL

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.

Physician Participants

Oncologists, and advanced practitioners caring for patients with breast, prostate, liver cancer including medical, surgical, radiation oncologists, interventional radiologists, urologists \& hepatologists

Group Type ACTIVE_COMPARATOR

Match-list intervention

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No