Cancer Clinical Trial
Official title:
Evaluating the Effectiveness of Blue-Button Automated Clinical Trial Prescreening on Regional Enrollment: A Randomized Trial
Verified date | January 2024 |
Source | American Cancer Society Cancer Action Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 1050 |
Est. completion date | June 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult cancer patients attending clinic visit at which they would be screened for clinical trial participation Exclusion Criteria: - under age 18 years |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Southwestern Simmons Comprehensive Cancer Center | Dallas | Texas |
United States | University of South Florida | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
American Cancer Society Cancer Action Network |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Participant reports on Blue-button tool usability | Providers and research coordinators will complete surveys to report the ease of use of the Blue-button prescreening tool as well as the time and effort involved.. | Quarterly surveys of research staff for the duration of the trial, up to 24 months. | |
Secondary | Patient reasons for non-enrollment | Patients who are offered matched clinical trials but choose not to enroll will complete a survey describing the reasons for their choice to not enroll. | 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). |
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