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

Trial Summary

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 data supports the idea that Outreach Strategies for Cancer Trial Enrollment (also known as: ACT WONDER²S) is an effective treatment?

The available research shows that strategies like financial reimbursement and patient navigation can improve cancer trial enrollment. For example, the IMPACT intervention, which included financial help and a patient guide, increased patient participation in cancer trials. This suggests that similar outreach strategies, like ACT WONDER²S, could also be effective in boosting trial enrollment, especially among underrepresented groups such as rural and disadvantaged populations. ^{1 2 3 4 5}

What is the purpose of 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.

Research Team

Susan T Vadaparampil, PhD, MPH

Principal Investigator

Moffitt Cancer Center

Dana Rollison, PhD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Involving American Indians and medically underserved rural populations in cancer clinical trials. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Accelerating cancer clinical trial recruitment through a financial reimbursement program integrated with patient navigation: an interrupted time series analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Improving enrollment in cancer clinical trials. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A screening tool to enhance clinical trial participation at a community center involved in a radiation oncology disparities program. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Ineligible, Unaware, or Uninterested? Associations Between Underrepresented Patient Populations and Retention in the Pathway to Cancer Clinical Trial Enrollment. [2023]