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

March 8, 2021 updated by: University of Chicago

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients at the University of Chicago Medical Center

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Touchscreen Participants
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Trials Attitudes, Knowledge, and Interest
Time Frame: 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.
Immediately after the visit.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the Feasibility and Acceptability of Multi-media Technology.
Time Frame: 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.
Immediately after the visit.
Clinical Trial Participation
Time Frame: 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.
About 6 months after the interview with participant.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

Northwestern University
Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Blase Polite, MD, University of Chicago Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2013

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

December 9, 2013

First Submitted That Met QC Criteria

December 23, 2013

First Posted (Estimate)

December 24, 2013

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB13-1233

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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