Effect of Multi-Media Tool on Enrollment in Oncology Clinical Trials

Study Overview
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Brief Summary
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The purpose of this research study is to test a touchscreen computer program, which allows patients to see information on a computer screen regarding cancer care, and specifically clinical trials. The purpose of this research is to help the investigators learn more about how to use technology in the medical setting to improve health outcomes.

Detailed Description
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Enrollment in therapeutic cancer trials remains low, and is especially challenging for patients with low health literacy. The purpose of this project is to pilot a multi-media technology intervention designed for patients with diverse health literacy skills with the aim of improving patient receptiveness, willingness, knowledge, self-efficacy, and positive attitudes regarding clinical trials. The intervention is comprised of multi-media touchscreen computer program components for clinical trial education and assessment of patient-reported outcomes. Patients presenting for their first oncology appointment were eligible. Patients viewed an interactive teaching video concerning clinical trials that was adapted from the National Institutes of Health. Validated surveys assessing receptiveness, willingness, knowledge, self-efficacy, and positive attitudes regarding clinical trials were administered before and after the test.

Official Title
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A Pilot Investigation to Examine the Effect of a Multi-Media, Computer Based Tool (Talking Touchscreen) on Enrollment in Adult Oncology-Specific Clinical Trials at an Academic Medical Center

Conditions
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Lung Cancer, Gastric Cancer, Pancreatic Cancer

Intervention / Treatment
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* Behavioral: Testing an interactive technology in a diverse health literary population


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult, English-speaking women and men Newly diagnosed with lung, gastric or pancreatic cancer Coming to the University of Chicago outpatient oncology clinics for their first oncology visit There are no Exclusion Criteria.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Touchscreen Participants<br>New lung, gastric and pancreatic cancer patients presenting to the University of Chicago outpatient oncology clinics, a large research institution located on Chicago's Southside, were identified for study accrual, using the electronic scheduling system. | Behavioral: Testing an interactive technology in a diverse health literary population<br>* Enrollment in therapeutic cancer trials remains low, and is especially challenging for patients with low health literacy. We tested an interactive technology designed for patients with diverse health literacy skills aimed at improving patient receptiveness, willingness, knowledge, self-efficacy and positive attitudes regarding clinical trials.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Trials Attitudes, Knowledge, and Interest | We hypothesized that our interactive educational tool would improve patient receptivity, willingness, knowledge, self-efficacy and positive attitudes regarding therapeutic cancer clinical trials through the use of patient-friendly technology in the immediate pre-visit period. Patients used the TT to self-administer 24 items from the Clinical Trial questionnaire developed by Jacobsen and colleagues measuring Receptivity (range: 1-5), Willingness (range: 1-5), Knowledge about cancer clinical trials (range: 0-6), Positive Attitudes toward clinical trials (range: 1-5), and Self-Efficacy (range: 1-5). A high score for each subscale represents a more favorable outcome. | Immediately after the visit. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the Feasibility and Acceptability of Multi-media Technology. | Secondary objectives of the study were to evaluate the feasibility and acceptability of multi-media technology for patient-reported outcomes (PRO) assessment and patient education in an oncology clinic. This was evaluated with a semi-structured interview with participants. | Immediately after the visit. | 
| Clinical Trial Participation | We used medical record abstraction to determine how many participants discussed clinical trials with their providers, how many were offered a clinical trial and how many were enrolled in a clinical trial. | About 6 months after the interview with participant. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical trials enrollment, communication, low health literacy, health disparities