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CancerACT WONDER²SNCT06560398

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

A study testing Continuing Medical Education Events (CME), Trial Connect Portal and Clinical Trial Newsletters in people with Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cancer
What is being tested?
Continuing Medical Education Events (CME), Trial Connect Portal and Clinical Trial Newsletters
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7,649 participants
Where
1 siteUnited States
Study dates
18 Sep 2024to 16 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rossybelle Amorrortu, MPH contact

813-745-4007

Rossybelle.Amorrortu@moffitt.org

Lindsay Fuzzell, PhD contact

Lindsay.Fuzzell@moffitt.org

United States1 site, 1 recruiting
  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Rossybelle Amorrortu, MPH, 813-745-4007, Rossybelle.Amorrortu@moffitt.org

    Lindsay Fuzzell, PhD, Linsday.Fuzzell@moffitt.org

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Conditions
Cancer
Being tested
Continuing Medical Education Events (CME), Trial Connect Portal, Clinical Trial Newsletters, Implicit Bias Training, Recruitment Dashboard
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuing Medical Education Events (CME)Behavioural

    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 PortalBehavioural

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

  • Clinical Trial NewslettersBehavioural

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

  • Implicit Bias TrainingBehavioural

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

  • Recruitment DashboardBehavioural

    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 ProfilerBehavioural

    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 CalculatorBehavioural

    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)Behavioural

    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)Behavioural

    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)Behavioural

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

  • No InterventionOther

    Control group with no intervention.

Study groups in NCT06560398
Study groupRoleWhat they receive
Catchment Area Priority Zone (CAPZ) Intervention - Community Residents and Moffitt PatientsExperimentalStudy interventions will be deployed in geographically defined intervention priority zones including Clinical Trial Education sessions and the ACT WONDER²S Phone-line/Email. Community residents in these zones may be exposed to these interventions. Residents who are also new patients to Moffitt may be exposed to the CHOICES DA website once they are registered at Moffitt.
Receives: Behavioral: Clinical Trial Education Sessions (Community Residents Only); Behavioral: ACT WONDER²S Phone-line/Email (Community Residents and Moffitt Patients); Behavioral: New Patient Information (Moffitt Patients Only)
Catchment Area Priority Zone (CAPZ) Control - Community Residents and Moffitt PatientsActive comparatorStudy interventions will not be deployed in the control priority zones. Community residents in these zones are unlikely to be exposed to any of the study interventions.
Receives: Other: No Intervention
Catchment Area Priority Zone (CAPZ) Intervention - Community PhysiciansExperimentalStudy interventions will be deployed in geographically defined intervention priority zones including Continuing Medical Education events, the Trial Connect Portal, and Clinical Trial Newsletters. Community physicians in these zones may be exposed to these interventions.
Receives: Behavioral: Continuing Medical Education Events (CME); Behavioral: Trial Connect Portal; Behavioral: Clinical Trial Newsletters
Catchment Area Priority Zone (CAPZ) Control- Community PhysiciansActive comparatorStudy interventions will not be deployed in the control priority zones. Community physicians in these zones are unlikely to be exposed to any of the study interventions.
Receives: Other: No Intervention
Cancer Center Clinical Research Coordinators (CRCs)ExperimentalCRCs that work on therapeutic clinical trials at Moffitt will have access to the implicit bias educational module and digital tools to monitor and enhance minority recruitment, including the Trial Connect Portal and Recruitment Dashboard.
Receives: Behavioral: Trial Connect Portal; Behavioral: Implicit Bias Training; Behavioral: Recruitment Dashboard
Cancer Center PhysiciansExperimentalPhysicians at Moffitt will have access to the implicit bias educational module and to digital tools to monitor and enhance minority recruitment, including the Trial Connect Portal, Recruitment Dashboard, Portfolio Profiler, and the Eligibility Criteria Calculator.
Receives: Behavioral: Trial Connect Portal; Behavioral: Implicit Bias Training; Behavioral: Recruitment Dashboard; Behavioral: Portfolio Profiler; Behavioral: Eligibility Calculator

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (5)
  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.

    Measured: 2 Years

  2. Community residents in the intervention CAPZ

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

    Measured: 2 years

  3. Community physicians in the intervention CAPZ

    The number of physicians that attend a CME event.

    Measured: 2 years

  4. Cancer Center CRC

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

    Measured: 2 years

  5. Cancer Center Physician

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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2024
  2. Study start18 Sep 2024
  3. Primary completion16 Sep 2026 (estimated)
  4. Study completion16 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
7,649 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06560398
Sponsor's protocol ID
MCC-22140
Other IDs
U01CA274971-01
Acronym
ACT WONDER²S
Status last verified
Sep 2026
First submitted
15 Aug 2024
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Continuing Medical Education Events (CME), Trial Connect Portal and Clinical Trial Newsletters in people with Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rossybelle Amorrortu, MPH (813-745-4007, Rossybelle.Amorrortu@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Enrollment of Black and Hispanic Patients to NCI-sponsored cancer treatment clinical trials (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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