Blue-Button Regional Trial Screening

NCT05885880 | Enrolling By Invitation

• 1 other identifier: 2018254-4
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cancer

Keywords

Cancer clinical trials; clinical trials screening; electronic health records (EHR)

Outcome Measures

Primary Outcomes (1)

• Rate of clinical trial participation

  To evaluate the effectiveness of an automated clinical trial prescreening tool ("Blue-button") in increasing enrollment in clinical trials compared to standard practice.

  Trial participation will be recorded for each patient for the duration of the trial, up to 24 months.

Secondary Outcomes (2)

• Participant reports on Blue-button tool usability

  Quarterly surveys of research staff for the duration of the trial, up to 24 months.

• Patient reasons for non-enrollment

  Surveys will be administered within 15 days (+/- 10 days) after patients inform their provider of their choice not to enroll, through study completion (up to 24 months).

Study Arms (2)

Standard of Care

NO 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.

Blue-button screening

EXPERIMENTAL

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.

Other: Blue-button screening

Interventions

Blue-button screening OTHER

Patients will be screened for clinical trial matches using the Blue-button tool

Blue-button screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult cancer patients attending clinic visit at which they would be screened for clinical trial participation

You may not qualify if:

• under age 18 years

Sponsors & Collaborators

• American Cancer Society Cancer Action Network: lead

Study Sites (2)

University of South Florida

Tampa, Florida, 33602, United States

Location

University of Texas Southwestern Simmons Comprehensive Cancer Center

Dallas, Texas, 75390, United States

Location

Related Publications (8)

• Comis RL, Miller JD, Aldige CR, Krebs L, Stoval E. Public attitudes toward participation in cancer clinical trials. J Clin Oncol. 2003 Mar 1;21(5):830-5. doi: 10.1200/JCO.2003.02.105.

  PMID: 12610181 BACKGROUND

• Fogel DB. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review. Contemp Clin Trials Commun. 2018 Aug 7;11:156-164. doi: 10.1016/j.conctc.2018.08.001. eCollection 2018 Sep.

  PMID: 30112460 BACKGROUND

• Melisko ME, Hassin F, Metzroth L, Moore DH, Brown B, Patel K, Rugo HS, Tripathy D. Patient and physician attitudes toward breast cancer clinical trials: developing interventions based on understanding barriers. Clin Breast Cancer. 2005 Apr;6(1):45-54. doi: 10.3816/CBC.2005.n.008.

  PMID: 15899072 BACKGROUND

• Torgerson DJ, Roland M. What is Zelen's design? BMJ. 1998 Feb 21;316(7131):606. doi: 10.1136/bmj.316.7131.606. No abstract available.

  PMID: 9518917 BACKGROUND

• Unger, JM, and Fleury, ME. Nationally representative estimates of the participation of cancer patients in clinical research studies according to the commission on cancer. Journal of Clinical Oncology 39, no. 28_suppl (October 01, 2021) 74-74

  BACKGROUND

• Unger JM, Hershman DL, Till C, Minasian LM, Osarogiagbon RU, Fleury ME, Vaidya R. "When Offered to Participate": A Systematic Review and Meta-Analysis of Patient Agreement to Participate in Cancer Clinical Trials. J Natl Cancer Inst. 2021 Mar 1;113(3):244-257. doi: 10.1093/jnci/djaa155.

  PMID: 33022716 BACKGROUND

• Unger JM, Vaidya R, Hershman DL, Minasian LM, Fleury ME. Systematic Review and Meta-Analysis of the Magnitude of Structural, Clinical, and Physician and Patient Barriers to Cancer Clinical Trial Participation. J Natl Cancer Inst. 2019 Mar 1;111(3):245-255. doi: 10.1093/jnci/djy221.

  PMID: 30856272 BACKGROUND

• Zelen M. A new design for randomized clinical trials. N Engl J Med. 1979 May 31;300(22):1242-5. doi: 10.1056/NEJM197905313002203.

  PMID: 431682 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Mark Fleury, PhD

  ACS CAN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: June 2, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• Access Criteria: IPD will be shared following review and approval of planned analyses and execution of data sharing agreement.

Locations

US (2)