Working Through Outreach, Navigation and Digital Enabled Referral and Recruitment Strategies (ACT WONDER²S)

ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Community residents, Community Physicians, Cancer Center Physicians, Clinical Research Coordinators, and Moffitt patients who do not meet the inclusion criteria.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Continuing Medical Education Events (CME)

    Behavioral

    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.

  • Trial Connect Portal

    Behavioral

    A digital tool to help facilitate rapid referral of patients to clinical trial opportunities at Moffitt.

  • Clinical Trial Newsletters

    Behavioral

    Electronic/paper newsletters to highlight open trials at Moffitt that will be distributed by email/mail.

  • Implicit Bias Training

    Behavioral

    A one-hour educational module will cover information on implicit bias to support the recruitment of diverse patients.

  • Recruitment Dashboard

    Behavioral

    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.

  • Portfolio Profiler

    Behavioral

    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.

  • Eligibility Calculator

    Behavioral

    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.

  • Clinical Trial Education Sessions (Community Residents Only)

    Behavioral

    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.

  • ACT WONDER²S Phone-line/Email (Community Residents and Moffitt Patients)

    Behavioral

    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.

  • New Patient Information (Moffitt Patients Only)

    Behavioral

    Including CHOICES DA, a web-based tool to improve multiple aspects of decision-making related to participation in cancer clinical trials.

  • No Intervention

    Other intervention

    Control group with no intervention.

Treatment groups

7,649 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Catchment Area Priority Zone (CAPZ) Intervention - Community Residents and Moffitt PatientsExperimental treatment 3 interventions
Group B: Catchment Area Priority Zone (CAPZ) Control - Community Residents and Moffitt PatientsActive comparator 1 intervention
Group C: Catchment Area Priority Zone (CAPZ) Intervention - Community PhysiciansExperimental treatment 3 interventions
Group D: Catchment Area Priority Zone (CAPZ) Control- Community PhysiciansActive comparator 1 intervention
Group E: Cancer Center Clinical Research Coordinators (CRCs)Experimental treatment 3 interventions
Group F: Cancer Center PhysiciansExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Enrollment of Black and Hispanic Patients to NCI-sponsored cancer treatment clinical trials

Intervention impact on enrollment rates 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.

Time frame
2 years

Secondary outcomes

1

Referral of Black and Hispanic Patients to Moffitt Cancer Center

Intervention impact on referral rates 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.

Time frame
2 Years
2

Community residents in the intervention CAPZ

The number of community residents that attend a CT educational session.

Time frame
2 years
3

Community physicians in the intervention CAPZ

The number of physicians that attend a CME event.

Time frame
2 years
4

Cancer Center CRC

The number of CRCs that used at least one of the CT digital tools.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

H. Lee Moffitt Cancer Center and Research Institute

Lead sponsor

National Cancer Institute (NCI)

Collaborator