Blue-Button Screening for Cancer Trials Enrollment

Enrolling by invitation at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: American Cancer Society Cancer Action Network

Disqualifiers: Under age 18

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to connect cancer patients with clinical trials using a tool called Blue-button screening. The goal is to determine if this method can help more cancer patients find and join clinical trials, making participation easier and quicker. It also aims to attract a more diverse group of participants who reflect the broader U.S. cancer population. Cancer patients attending a clinic visit and interested in joining a clinical trial may be suitable for this study. As an unphased trial, this study offers a unique opportunity for patients to contribute to innovative research that could enhance access to clinical trials for others.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Blue-button screening is safe for increasing clinical trial enrollment?

Research shows that the Blue-button screening tool helps match cancer patients with suitable clinical trials. This tool is not a drug or medical treatment, so it doesn't pose the health risks associated with new medications.

In past studies, the Blue-button tool used anonymous data from electronic health records to find trial matches, ensuring personal information remains private and secure. No reports of problems or safety issues have arisen from using this tool. It offers a safer and more efficient way to connect patients with potentially beneficial clinical trials.

This trial phase does not test a new medical treatment. Instead, it aims to improve how patients are matched with trials, focusing on the tool's effectiveness rather than patient safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Blue-button screening because it offers a new approach to matching patients with cancer clinical trials. Unlike the standard of care, which relies on routine screening or none at all, this method uses deidentified data from electronic health records to efficiently identify eligible trials. By streamlining the process and potentially increasing trial enrollment, the Blue-button screening could lead to more personalized treatment options and quicker access to cutting-edge therapies for patients.

What evidence suggests that the Blue-button screening is effective for increasing cancer clinical trial enrollment?

Research has shown that using electronic health records (EHRs) to automatically prescreen patients can simplify the process of finding and joining clinical trials. In this trial, participants in the Blue-button screening arm will have deidentified data elements transferred from their EHR to the Blue-button tool to identify clinical trials for which they may be eligible. This method has proven promising in speeding up trial enrollment and reducing the need for staff. It is particularly effective at identifying trials for groups often underrepresented. Overall, improved trial enrollment has been linked to better survival rates in common cancers like breast cancer. ^{1 4 6 7 8}

Who Is on the Research Team?

Mark Fleury, PhD

Principal Investigator

ACS CAN

Are You a Good Fit for This Trial?

This trial is for adult cancer patients who are visiting the clinic and could be screened for clinical trial participation. It aims to integrate a new method of identifying suitable trials as part of routine care, potentially increasing enrollment and diversity in cancer clinical trials.

Inclusion Criteria

I am an adult cancer patient here for a clinic visit.

Exclusion Criteria

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Blue-button screening

Subjects have deidentified data elements transferred from their EHR to the Blue-button tool for identification of clinical trials for which they may be eligible.

Up to 24 months

Follow-up

Participants are monitored for trial participation and reasons for non-enrollment.

Up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Blue-button screening

Trial Overview The Blue-Button screening process is being tested to see if it can improve the rate at which cancer patients enroll in clinical trials by making it easier to find relevant studies during regular healthcare visits.

How Is the Trial Designed?

Group I: Blue-button screening Experimental Treatment 1 Intervention

Subjects assigned to this arm will have deidentified data elements transferred from their EHR to the Blue-button tool for identification of clinical trials for which they may be eligible. After review by clinical research staff, appropriate trials will be offered to subjects.

Group II: Standard of Care Active Control 1 Intervention

Subjects in this arm will receive the standard of care, either routine screening for clinical trials or no screening, according to standard institutional protocol. Potential clinical trials, if identified, will be offered to subjects according to the usual institutional process.

Who Is Running the Clinical Trial?

American Cancer Society Cancer Action Network

Lead Sponsor

Trials

1

Recruited

1,100+

Published Research Related to This Trial

The PLCO Cancer Screening Trial aims to enroll nearly 150,000 participants across ten centers in the U.S., with a main recruitment phase planned for 3 years following a 1-year pilot phase.

To enhance enrollment, especially among minority groups, the National Cancer Institute implemented targeted recruitment strategies and made protocol adjustments based on the experiences of individual screening centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recruitment strategies in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial: the first six years. Simpson, NK., Johnson, CC., Ogden, SL., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05885880

NCT05885880 | Blue-Button Regional Trial Screening Enrollment in clinical trials predicts better survival in the most common cancer types including breast cancer, and testing and proving the efficacy of new ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS1658

Trial in progress: Evaluating the effectiveness of Blue ... Automated prescreening using electronic health records (EHRs) offers a promising solution to streamline trial identification and improve access.

3. fightcolorectalcancer.org fightcolorectalcancer.org/blog/blue-button-matching/

Blue-button matching The Blue-button tool provides basic trial screening within EHRs by sending a select number of de-identified, standardized patient data elements ...

4. withpower.com withpower.com/trial/phase-malignancies-5-2023-b0678

Blue-Button Screening for Cancer Trials Enrollment The research highlights the importance of effective screening processes in improving cancer trial enrollment, particularly for underrepresented populations.

5. fightcancer.org fightcancer.org/sites/default/files/national_documents/acscan-blue-button-2024-rfp-call-for-interest-v2.pdf

Blue-button Integrated Clinical Trial Matching ... After successful feasibility testing, we launched a clinical trial to assess the effectiveness of the Blue- button tool with patients in a ...

6. fightcancer.org fightcancer.org/blue-button-clinical-trial-matching-cancer-patients

Blue-button Clinical Trial Matching for Cancer Patients A new tool, called “Blue-button”, that can automatically identify relevant clinical trials through one-button clinical trial matching integration within ...

7. fightcancer.org fightcancer.org/sites/default/files/docs/resources/rfp_ct_integratedmatching_october_5_2022.pdf

Blue-button Integrated Clinical Trial Matching Pilot Study ... The eight patient data elements used for prescreening include age, cancer type, cancer subtype, presence of metastasis, stage, biomarkers ...

8. careacross.com careacross.com/clinical-trials/trial/NCT05885880

Blue-Button Regional Trial Screening Summary: Enrollment in clinical trials predicts better survival in the most common cancer types including breast cancer, and testing and proving the efficacy of ...