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Diversity and Inclusion in Research Underpinning Prevention and Therapy Trials (DISRUPT)

Primary Purpose

Breast Cancer, Liver Cancer, Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical trial match-list
Match-list intervention
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Albert Einstein College of Medicine
  • Icahn School of Medicine at Mount SinaiRecruiting
  • Herbert Irving Comprehensive Cancer Care Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Patient Participants

Physician Participants

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
November 22, 2021
Last Updated
February 24, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT05146297
Brief Title
Diversity and Inclusion in Research Underpinning Prevention and Therapy Trials
Acronym
DISRUPT
Official Title
Diversity and Inclusion in Research Underpinning Prevention and Therapy Trials
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 24, 2022 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Liver Cancer, Prostate Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1705 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient Participants
Arm Type
Active Comparator
Arm Description
Patients with invasive breast, prostate or liver cancer, who face a treatment decision
Arm Title
Physician Participants
Arm Type
Active Comparator
Arm Description
Oncologists, and advanced practitioners caring for patients with breast, prostate, liver cancer including medical, surgical, radiation oncologists, interventional radiologists, urologists & hepatologists
Intervention Type
Behavioral
Intervention Name(s)
Clinical trial match-list
Intervention Description
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
Intervention Name(s)
Match-list intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Clinical Trial Accrual
Description
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 Outcome Measure Information:
Title
Number of physicians agree to usefulness of the match lists
Description
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
Title
Patient Post-intervention Survey
Description
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
Title
Physician Post -intervention survey
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Radhi Yagnik
Phone
212-659-5933
Email
radhi.yagnik@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina Bickell
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ariana Tao
First Name & Middle Initial & Last Name & Degree
Bruce Rapkin
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radhi Yagnik
Email
radhi.yagnik@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Nina Bickell
Facility Name
Herbert Irving Comprehensive Cancer Care Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Burke
First Name & Middle Initial & Last Name & Degree
Mary Beth Terry

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
undecided

Learn more about this trial

Diversity and Inclusion in Research Underpinning Prevention and Therapy Trials

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