1050 Participants Needed

Blue-Button Screening for Cancer Trials Enrollment

Recruiting at 2 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: American Cancer Society Cancer Action Network
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Enrollment in clinical trials predicts better survival in the most common cancer types including breast cancer, and testing and proving the efficacy of new treatments relies on successfully conducting clinical trials. However, approximately one fifth of cancer clinical trials fail due to insufficient patient enrollment, and only about 6% of adult cancer patients are enrolled onto clinical trials. Barriers remain for patient participation in clinical trials, especially for cancer patients. One specific barrier is trial identification and awareness of trial availability for both patients and providers. This trial tests the hypothesis that by integrating clinical trial eligibility screening into part of routine care in a way that requires little effort and by making that screening site agnostic, the Blue-Button matching functionality will increase overall cancer clinical trial enrollment, and may also result in more diverse clinical trial participants that better reflect the U.S. cancer population. Moreover, regardless of changes in enrollment, the Blue-button screening may allow screening to be done more quickly with fewer human resources when compared to current methods. Identification of potential trial opportunities, however, is only the first barrier to trial enrollment, so this study includes additional examination of barriers subsequent to the identification of relevant trials by cataloging patient-level barriers that prevent enrollment of patients in identified trials.

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 data supports the effectiveness of the treatment 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. While not directly about Blue-button screening, the studies suggest that automated and comprehensive screening methods can enhance trial participation and potentially improve cancer outcomes.12345

How does the Blue-Button Screening treatment differ from other cancer treatments?

The Blue-Button Screening treatment is unique because it focuses on using electronic health records to automatically match cancer patients with clinical trials, potentially increasing trial participation and improving representation of diverse populations. This approach differs from traditional treatments as it emphasizes trial enrollment rather than direct medical intervention.12678

Research Team

MF

Mark Fleury, PhD

Principal Investigator

ACS CAN

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Blue-button screeningExperimental Treatment1 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 CareActive Control1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

American Cancer Society Cancer Action Network

Lead Sponsor

Trials
1
Recruited
1,100+

Findings from Research

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.
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]

References

Feasibility of institution-agnostic, EHR-integrated regional clinical trial matching. [2023]
Use of the National Cancer Institute Community Cancer Centers Program screening and accrual log to address cancer clinical trial accrual. [2022]
Cancer Screening: Patient and Population Strategies. [2023]
Impact of cancer screening on metastasis: A prostate cancer case study. [2022]
Improved survival of non-small cell lung cancer patients after introducing patient navigation: A retrospective cohort study with propensity score weighted historic control. [2022]
Factors and outcomes of decision making for cancer clinical trial participation. [2022]
Recruitment strategies in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial: the first six years. [2022]
Cancer clinical trial enrollment of diverse and underserved patients within an urban safety net hospital. [2022]