Outreach Strategies for Cancer Trial Enrollment

(ACT WONDER²S Trial)

Overseen By Lindsay Fuzzell, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Not meeting inclusion criteria

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

7649 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how Black and Hispanic patients join cancer treatment studies at Moffitt Cancer Center. The focus is on testing new tools and strategies, such as educational sessions and digital platforms, to help doctors and research coordinators better engage these communities. Participants may include residents or physicians in specific areas or patients newly registered at Moffitt. Those living in these areas or new patients at Moffitt might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to enhancing healthcare access and inclusivity.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that these outreach strategies are safe for increasing trial enrollment?

Research has shown that ACT WONDER²S is a program designed to help more Black and Hispanic patients join cancer clinical trials by reducing obstacles through education and outreach. Specific safety data for ACT WONDER²S does not exist because it is a strategy, not a drug or treatment.

As a "Not Applicable" phase trial, the focus is on methods and strategies, not on testing new drugs or procedures. This indicates no immediate safety concerns, as it does not involve taking medicine or undergoing medical procedures. Instead, it uses educational and digital tools to facilitate participation in clinical trials. Consequently, the program is generally considered safe, as it primarily provides information and support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to enhance participation in cancer clinical trials, especially among minority groups, by tackling implicit bias and improving recruitment strategies. Unlike traditional enrollment methods, this trial leverages educational modules and digital tools, like the Trial Connect Portal and Recruitment Dashboard, to empower research coordinators and physicians at Moffitt. By integrating these innovative tools, the trial hopes to make clinical trials more inclusive and representative, ultimately leading to more comprehensive cancer research outcomes.

What evidence suggests that this trial's interventions could be effective for increasing enrollment of Black and Hispanic patients in cancer clinical trials?

Research shows that ACT WONDER²S aims to increase the number of Black and Hispanic patients in cancer clinical trials. This trial tests different strategies to achieve this goal. For instance, Cancer Center Clinical Research Coordinators and Physicians at Moffitt will use online tools and educational materials to help overcome obstacles to joining these trials. Meanwhile, interventions in Catchment Area Priority Zones will include Clinical Trial Education sessions and the ACT WONDER²S Phone-line/Email for community residents and Moffitt patients, as well as Continuing Medical Education events for community physicians. These tools address issues that often prevent minority groups from participating. By improving access and awareness, ACT WONDER²S aims to boost participation rates, making trials more representative and inclusive. While specific data on effectiveness isn't detailed, the organized approach seems promising for enhancing trial diversity. ^{1 3 4 6 7}

Who Is on the Research Team?

Dana Rollison, PhD

Principal Investigator

Moffitt Cancer Center

Susan T Vadaparampil, PhD, MPH

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for Black and Hispanic individuals interested in participating in cancer clinical trials at Moffitt Cancer Center. It aims to increase their enrollment in NCI-sponsored therapeutic clinic trials.

Inclusion Criteria

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 practice medicine in one of the geographic priority zones

Cancer Center Physicians may engage with various intervention components if they practice medicine at Moffitt

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Deployment

Deployment of multi-level interventions including outreach, education, and digital tools to increase enrollment of Black and Hispanic patients to NCI-sponsored clinical trials

2 years

Ongoing engagement with community residents, physicians, and Moffitt staff

Follow-up

Participants are monitored for the impact of interventions on enrollment and referral rates

2 years

What Are the Treatments Tested in This Trial?

Interventions

• ACT WONDER²S

Trial Overview The study tests a multi-level intervention including patient information, digital portals, educational events, an eligibility calculator, newsletters, recruitment dashboard, implicit bias training and support lines to improve trial enrollment rates.

How Is the Trial Designed?

Group I: Catchment Area Priority Zone (CAPZ) Intervention - Community Residents and Moffitt Patients Experimental Treatment 3 Interventions

Study 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.

Group II: Catchment Area Priority Zone (CAPZ) Intervention - Community Physicians Experimental Treatment 3 Interventions

Study 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.

Group III: Cancer Center Physicians Experimental Treatment 5 Interventions

Physicians 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.

Group IV: Cancer Center Clinical Research Coordinators (CRCs) Experimental Treatment 3 Interventions

CRCs 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.

Group V: Catchment Area Priority Zone (CAPZ) Control - Community Residents and Moffitt Patients Active Control 1 Intervention

Study 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.

Group VI: Catchment Area Priority Zone (CAPZ) Control- Community Physicians Active Control 1 Intervention

Study 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.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 891 new cancer patients at a community cancer care center, only 9% were enrolled in clinical trials, primarily due to a lack of relevant protocols or restrictive inclusion criteria.

Despite low overall enrollment, the participation rate was about three times higher than national averages, and targeted patient navigation programs helped increase enrollment among American Indian patients to 10%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Involving American Indians and medically underserved rural populations in cancer clinical trials. Guadagnolo, BA., Petereit, DG., Helbig, P., et al.[2022]

In a study of 512 breast and ovarian cancer patients, eligibility for clinical trials was similar across different racial and socioeconomic groups, indicating that barriers to enrollment are not due to eligibility criteria.

Black patients showed significantly lower odds of interest (0.40) and enrollment (0.56) in clinical trials compared to White patients, while those from disadvantaged neighborhoods had lower odds of enrolling (0.46) and higher odds of declining enrollment (3.40), highlighting the need for targeted interventions to improve participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ineligible, Unaware, or Uninterested? Associations Between Underrepresented Patient Populations and Retention in the Pathway to Cancer Clinical Trial Enrollment. Caston, NE., Lalor, F., Wall, J., et al.[2023]

The IMPACT intervention, which included a patient navigator and financial reimbursement for out-of-pocket costs, significantly increased patient enrollment in cancer treatment clinical trials, particularly in late phase trials, with an average increase of one additional patient per month.

Over the study period from January 2016 to March 2020, a total of 3470 patients were enrolled, highlighting the importance of addressing financial barriers to improve recruitment and ensure diverse representation in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerating cancer clinical trial recruitment through a financial reimbursement program integrated with patient navigation: an interrupted time series analysis. Borno, HT., Lin, TK., Zhang, S., et al.[2022]

The screening tool effectively identified eligible patients for clinical trials at a community radiation oncology center, with 67% of patients screened during the 9-month study period.

Out of 24 patients eligible for external beam radiation therapy trials, 15 accepted participation, indicating that the tool successfully facilitated trial enrollment despite a shortage of available trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A screening tool to enhance clinical trial participation at a community center involved in a radiation oncology disparities program. Proctor, JW., Martz, E., Schenken, LL., et al.[2021]

A survey of 84 clinical research nurses in New Jersey revealed that emphasizing patient safety and keeping physicians informed about clinical trial protocols are crucial for successful recruitment.

Effective strategies to raise public awareness about clinical trials include showcasing past participants and promoting the value of trials through nonprofit campaigns, with cancer centers showing less concern for physician education on trial benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving enrollment in cancer clinical trials. Connolly, NB., Schneider, D., Hill, AM.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06560398

Study Details | NCT06560398 | Working Through Outreach ... The primary outcome, enrollment to clinical trials, will be measured by comparing the percentage of Moffitt patients enrolled on NCI-supported treatment trials ...

2. researchgate.net researchgate.net/publication/395729141_Design_of_a_cluster_randomized_multi-level_intervention_to_decrease_barriers_to_minority_cancer_patient_referral_and_enrollment_to_cancer_clinical_trials_The_ACT_WONDER2S_study

Design of a cluster randomized multi-level intervention to ... ... cancer clinical trials: The ACT WONDER2S study ... data focused on institutional factors related to minority recruitment for cancer clinical trials.

3. lab.moffitt.org lab.moffitt.org/act-wonder2s/

ACT WONDER2S - Logo - Moffitt Cancer Center Funded by the National Cancer Institute and part of the CP2CT network, the goal of the ACT WONDER2S study is to increase referral and enrollment of patients to ...

4. clin.larvol.com clin.larvol.com/trial-detail/NCT06560398

Working Through Outreach, Navigation and Digital ... Moffitt Cancer Center. ACT WONDER²S / NCT06560398. Working Through Outreach, Navigation and Digital Enabled Referral and Recruitment Strategies (ACT WONDER²S).

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11009859/

Patient-Reported Outcomes as a Recruitment Strategy for ... The results of this study suggest that ePROs are a promising method to facilitate patient recruitment to symptom-intervention trials and may be ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40992541/

Design of a cluster randomized multi-level intervention to ... Presented here are the study design and baseline characteristics of ACT WONDER2S, a multi-level intervention (MLI) aimed to decrease barriers to ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40992520/

Effectiveness and Efficiency of an Add-on Active Outreach ... Objective: To evaluate the effectiveness and efficiency of the add-on active outreach compared to the mail invitation-based passive enrollment ...