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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02020252
Recruitment Status : Completed
First Posted : December 24, 2013
Results First Posted : March 10, 2021
Last Update Posted : March 10, 2021
Sponsor:
Collaborators:
Northwestern University
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
University of Chicago

Study Description
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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.

Condition or disease Intervention/treatment
Lung Cancer Gastric Cancer Pancreatic Cancer Behavioral: Testing an interactive technology in a diverse health literary population

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 Design
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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : November 26, 2013
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Clinical Trials

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at the University of Chicago Medical Center
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020252


Locations
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United States, Illinois
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Northwestern University
Merck Sharp & Dohme LLC
Investigators
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Principal Investigator: Blase Polite, MD University of Chicago Comprehensive Cancer Center
  Study Documents (Full-Text)

Documents provided by University of Chicago:
Study Protocol and Statistical Analysis Plan  [PDF] October 28, 2014

More Information
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Publications of Results:

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02020252    
Other Study ID Numbers: IRB13-1233
First Posted: December 24, 2013    Key Record Dates
Results First Posted: March 10, 2021
Last Update Posted: March 10, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Chicago:
clinical trials enrollment
communication
low health literacy
health disparities