Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials (NCT05886764) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials
United States134 participantsStarted 2023-10-23
Plain-language summary
This trial will study different outreach methods to assess impact on enrollment of underrepresented minorities (specifically African Americans) to early phase cancer clinical treatment trials. Both patients and providers (those seeing enrolled patients) will be enrolled and receive the study interventions or no intervention (control arm).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for Patient Subjects:
* Aged 18 years or older
* Self-described African American race (patients who self-describe as "more than one race" will be included)
* Scheduled for new or consult oncology appointment at the study site
* Scheduled for return outpatient oncology appointment at the study site with a biopsy or radiology encounter within 2 weeks prior to provider visit.
* for prostate cancer patients: 2 or more increasing prostate specific antigen (PSA) values i the 6 months prior to visit
* other patient identified by research team as potentially having a change in treatment prior to next outpatient oncology appointment at the study site
Inclusion Criteria for Provider Subjects:
* oncology provider at study site scheduled to see patients meeting criteria above
Exclusion Criteria for Patient Subjects:
* Estimated glomerular filtration rate (GFR) less than 30 ml/min/1.73m2 documented within last 2 months and without documented resolutions
* Bilirubin greater than 3.0 ng/dl documented within last 2 months and without documented resolution
* Initiated new anti-cancer therapy within last 2 months
* Evaluated for possible enrollment/randomization in the last 2 months
* Prior enrollment/randomization on this recruitment trial
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of patients that enroll to early phase cancer treatment clinical trials.