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

Completed

• Conditions: Lung Cancer; Gastric Cancer; Pancreatic Cancer
• Interventions: Behavioral: Testing an interactive technology in a diverse health literary population

• Registration Number: NCT02020252
• Lead Sponsor: University of Chicago

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-11-26
• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2013-12-23
• Study First Posted: 2013-12-24
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Results First Submitted: 2019-06-04
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-08
• Last Update Submitted: 2021-03-08
• Results First Posted: 2021-03-10
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Touchscreen Participants	Testing an interactive technology in a diverse health literary population	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.

Primary Outcome Measures

Name	Time	Method
Clinical Trials Attitudes, Knowledge, and Interest	Immediately after the visit.	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.

Secondary Outcome Measures

Name	Time	Method
Evaluate the Feasibility and Acceptability of Multi-media Technology.	Immediately after the visit.	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.
Clinical Trial Participation	About 6 months after the interview with participant.	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.

Trial Locations

Locations (1)

University of Chicago Comprehensive Cancer Center; 🇺🇸 Chicago, Illinois, United States