Diversity and Inclusion in Research Underpinning Prevention and Therapy Trials

Study Overview
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Brief Summary
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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.

Official Title
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Diversity and Inclusion in Research Underpinning Prevention and Therapy Trials

Conditions
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Breast Cancer, Liver Cancer, Prostate Cancer

Intervention / Treatment
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* Behavioral: Clinical trial match-list
* Behavioral: Match-list intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients >21 years of age with invasive breast, prostate 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 will be eligible to participate. For provider recruitment, oncologists, and advanced practitioners caring for patients with breast, prostate, liver cancer including medical, surgical, radiation oncologists, interventional radiologists, urologists & hepatologists. Exclusion Criteria: Patients who are unable to give consent unable to understand English or Spanish lack of invasive breast/prostate/liver cancer those who do not face an imminent treatment decision

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patient Participants<br>Patients with invasive breast, prostate or liver cancer, who face a treatment decision | Behavioral: Clinical trial match-list<br>* 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.<br>|
| Active Comparator: Physician Participants<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical Trial Accrual | 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 | 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 | 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 | 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 |