Blue-Button Regional Trial Screening

Part of paid clinical trials in Tampa, Florida.

Sponsor
American Cancer Society Cancer Action Network
Study ID
NCT05885880
Status
Enrolling By Invitation

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blue-button screening — OTHER
    Patients will be screened for clinical trial matches using the Blue-button tool

Study Details

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.

Key Dates

Start date
Dec 1, 2023
Status verified
Jan 2025
Primary completion
Dec 31, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
1,050 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: Standard of Care
    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.
  • Experimental: Blue-button screening
    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.

Primary Outcome Measure

Rate of clinical trial participation [ Time Frame: Trial participation will be recorded for each patient for the duration of the trial, up to 24 months. ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of South FloridaTampaFlorida33602-
University of Texas Southwestern Simmons Comprehensive Cancer CenterDallasTexas75390-

Find similar trials in Tampa, FL

By research site
University of South Florida· Tampa, FLUniversity of Texas Southwestern Simmons Comprehensive Cancer Center· Dallas, TX

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