Overview
The Need: Many clinical trials struggle to quickly accrue and then retain cancer patients. These issues have tremendous financial ramifications for both industry and academia. Barriers in accrual impact trial sponsors and patients alike by delaying access to study interventions, knowledge of findings, translation of research results and sometimes wide spread availability of new treatments.
The Solution: CISN provides a number of services to the medical community around issues affecting clinical trials accrual and retention.
A. Developing Educational Materials About Clinical Trials
The Need: In today’s fast paced clinical practice, very little time is spent educating patients about clinical trials in general or the specific clinical trial they may be eligible for. During the informed consent or informed choice process, a complicated component involves the period of decisional conflict experienced by people faced with life or death decisions. Research studies indicate that decisional conflict involves emotional, physical, and cognitive overload.
The Solution: Patients require concise, clear patient focused educational materials designed to lesson the overload they are experiencing. It is our contention that if patients have a clear understanding of a clinical trial they are more likely to enroll. CISN develops patient-centered, study specific, educational materials included as part of the informed consent process. These may enhance patient literacy, improve patient satisfaction, and advance public trust in the research enterprise, all of which lead to increased accrual and retention. CISN educational materials also cover the spectrum of learning styles to ensure broad understanding by readers.
Examples:
- Consent forms with patient centered content and language
- Introductory letters about research studies with substance and heart from the patient’s perspective
- Patient centered brochures about clinical trials
- Tips sheets, fact sheets, and newsletters about clinical trials
- Color-coded flowcharts:
a. Help patients understand their time and procedure commitment
b. Serve as a study calendar
c. Explain complicated information to newly diagnosed cancer patients
d. Assist patients in clarifying differences between standard treatment and study treatment,
as well as contrasting expectations through comparison flowcharts
- Clear charts comparing side effects of standard care and study treatments.