Trial Title:
Working Through Outreach, Navigation and Digital Enabled Referral and Recruitment Strategies (ACT WONDER²S)
NCT ID:
NCT06560398
Condition:
Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Continuing Medical Education Events (CME)
Description:
An engaging 1-hour informational session focusing on topic areas such as implicit bias
and emerging evidence from recent cancer clinical trials with CME credit or American
Board of Internal Medicine (ABIM) Maintenance of Certification (MOC) points available.
Arm group label:
Catchment Area Priority Zone (CAPZ) Intervention - Community Physicians
Intervention type:
Behavioral
Intervention name:
Trial Connect Portal
Description:
A digital tool to help facilitate rapid referral of patients to clinical trial
opportunities at Moffitt.
Arm group label:
Cancer Center Clinical Research Coordinators (CRCs)
Arm group label:
Cancer Center Physicians
Arm group label:
Catchment Area Priority Zone (CAPZ) Intervention - Community Physicians
Intervention type:
Behavioral
Intervention name:
Clinical Trial Newsletters
Description:
Electronic/paper newsletters to highlight open trials at Moffitt that will be distributed
by email/mail.
Arm group label:
Catchment Area Priority Zone (CAPZ) Intervention - Community Physicians
Intervention type:
Behavioral
Intervention name:
Implicit Bias Training
Description:
A one-hour educational module will cover information on implicit bias to support the
recruitment of diverse patients.
Arm group label:
Cancer Center Clinical Research Coordinators (CRCs)
Arm group label:
Cancer Center Physicians
Intervention type:
Behavioral
Intervention name:
Recruitment Dashboard
Description:
A dynamic dashboard depicting the number of patients recruited to clinical trials by
gender, race, ethnicity, age, cancer type, residence in the catchment area, and other key
clinical characteristics.
Arm group label:
Cancer Center Clinical Research Coordinators (CRCs)
Arm group label:
Cancer Center Physicians
Intervention type:
Behavioral
Intervention name:
Portfolio Profiler
Description:
An interactive dashboard to allow cancer center physicians easily identify gaps in the
current clinical trial portfolio that may be contributing to racial/ethnic disparities in
trial enrollment.
Arm group label:
Cancer Center Physicians
Intervention type:
Behavioral
Intervention name:
Eligibility Calculator
Description:
A digital calculator that will allow for assessment of the potential impact of clinical
trial eligibility criteria (e.g., comorbidities, age, lab values) that may
disproportionately exclude patients who are Black and Hispanic prior to submission of
clinical trial protocols to the Scientific Review Committee.
Arm group label:
Cancer Center Physicians
Intervention type:
Behavioral
Intervention name:
Clinical Trial Education Sessions (Community Residents Only)
Description:
An engaging 1-hour educational session delivered by a community health educator that
includes basic information about clinical trials, their importance, myths, need for
diversity in the trials process, and resources for finding more information about
clinical trials.
Arm group label:
Catchment Area Priority Zone (CAPZ) Intervention - Community Residents and Moffitt Patients
Intervention type:
Behavioral
Intervention name:
ACT WONDER²S Phone-line/Email (Community Residents and Moffitt Patients)
Description:
A study team member will be available for questions via a dedicated phone-line and email
for community residents and Moffitt patients with a return contact within 24-hours.
Arm group label:
Catchment Area Priority Zone (CAPZ) Intervention - Community Residents and Moffitt Patients
Intervention type:
Behavioral
Intervention name:
New Patient Information (Moffitt Patients Only)
Description:
Including CHOICES DA, a web-based tool to improve multiple aspects of decision-making
related to participation in cancer clinical trials.
Arm group label:
Catchment Area Priority Zone (CAPZ) Intervention - Community Residents and Moffitt Patients
Intervention type:
Other
Intervention name:
No Intervention
Description:
Control group with no intervention.
Arm group label:
Catchment Area Priority Zone (CAPZ) Control - Community Residents and Moffitt Patients
Arm group label:
Catchment Area Priority Zone (CAPZ) Control- Community Physicians
Summary:
The purpose of the study is to refine, finalize, implement, and evaluate a multi-level
intervention aimed at increasing enrollment of Black and Hispanic patients to National
Cancer Institute (NCI)-sponsored therapeutic clinic trials at Moffitt Cancer Center.
Detailed description:
A stratified cluster randomized design will be used to assess the impact of the Advancing
Clinical Trials: Working through Outreach, Navigation, and Digitally Enabled Referral and
Recruitment Strategies (ACT WONDER²S) multi-level intervention on increasing referral and
enrollment to NCI-sponsored therapeutic clinical trials among Black and Hispanic
patients. Geospatial analytics were used to identify clusters of census tracts within the
Moffitt catchment area ("priority zones") with high Black and Hispanic populations for
intervention deployment. Priority zones were then matched on population characteristics
and randomized to receive the intervention (n=7) or to serve as controls (n=7).
External target populations within the Catchment Area Priority Zone (CAPZ) include
community residents and community physicians, while internal target populations within
Moffitt Cancer Center (Moffitt) include physicians, clinical research coordinators
(CRCs), and patients. The outreach and education intervention components will be
facilitated by community health educators (CHEs) targeting community residents (Clinical
Trial Education module and CHE support through the ACT WONDER²S Phone-line/Email),
community physicians (Continuing Medical Education sessions including implicit bias
training), patients at Moffitt (CHE support) and cancer center physicians/CRCs (an
implicit bias training). Digitally enabled decision support tools will be developed and
deployed to the CHE's (a data-empowered interactive map for outreach planning [Precision
Engagement Tool]), community physicians (Clinical Trial Newsletters), patients at Moffitt
(a clinical trial decision aid [CHOICES DA]), and cancer center physicians/CRCs (a
recruitment dashboard to monitor clinical trial accrual rates, a clinical trial portfolio
profiler, and a tool to assess the impact of clinical trial inclusion/exclusion criteria
on eligibility across patient populations defined by age, race, and ethnicity
[Eligibility Criteria Calculator]). In addition, an online portal (called the Trial
Connect Portal) will be developed to connect community-based referring physicians to
information about MCC trials and to facilitate their communication with cancer center
physicians and CRCs. The primary outcome, enrollment to clinical trials, will be measured
by comparing the percentage of Moffitt patients enrolled on NCI-supported treatment
trials who are Black or Hispanic between intervention priority zones and the control
priority zones. The secondary outcome, referral to Moffitt, will be measured by comparing
the percentage of patients referred to Moffitt who are Black or Hispanic between the
intervention priority zones and the control priority zones.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Community residents: Community residents may engage with various intervention
components deployed in the intervention priority zones.
- Community Physicians: may engage with various intervention components deployed in
the intervention priority zones if they 1) practice medicine in one of the
geographic priority zones.
- Cancer Center Physicians: may engage with various intervention components if they 1)
practice medicine at Moffitt.
- Clinical Research Coordinators (CRC): may engage with various intervention
components if they 1) work as a CRC at Moffitt and 2) coordinate/pre-screen patients
for at least 1 therapeutic clinical trial at Moffitt.
- Cancer Center Patients: may engage with various intervention components if they have
an address that maps to an intervention priority zone and 2) are newly registered
patients or new existing patients (NEPs).
Exclusion Criteria:
- Community residents, Community Physicians, Cancer Center Physicians, Clinical
Research Coordinators, and Moffitt patients who do not meet the inclusion criteria.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rossybelle Amorrortu, MPH
Phone:
813-745-4007
Email:
Rossybelle.Amorrortu@moffitt.org
Contact backup:
Last name:
Lindsay Fuzzell, PhD
Email:
Linsday.Fuzzell@moffitt.org
Investigator:
Last name:
Susan Vadaparampil, PhD
Email:
Principal Investigator
Investigator:
Last name:
Dana Rollison, PhD
Email:
Principal Investigator
Investigator:
Last name:
Kea Turner, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Kedar Kirtane, MD
Email:
Sub-Investigator
Investigator:
Last name:
Hatem Soliman, MD
Email:
Sub-Investigator
Investigator:
Last name:
Margaret Byrne, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Cathy Meade, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Clement Gwede, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Steven Eschrich, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Vivien Yin, PhD
Email:
Sub-Investigator
Start date:
June 8, 2023
Completion date:
September 1, 2026
Lead sponsor:
Agency:
H. Lee Moffitt Cancer Center and Research Institute
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
H. Lee Moffitt Cancer Center and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06560398
https://www.moffitt.org/clinical-trials-research/clinical-trials/
