Effect of Multi-Media Tool on Enrollment in Oncology Clinical Trials
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|ClinicalTrials.gov Identifier: NCT02020252|
Recruitment Status : Completed
First Posted : December 24, 2013
Results First Posted : March 10, 2021
Last Update Posted : March 10, 2021
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|Condition or disease||Intervention/treatment|
|Lung Cancer Gastric Cancer Pancreatic Cancer||Behavioral: Testing an interactive technology in a diverse health literary population|
|Study Type :||Observational|
|Actual Enrollment :||120 participants|
|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|
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.
- 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.
- 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.
- 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.
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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|
- 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.
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
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Blase Polite, MD||University of Chicago Comprehensive Cancer Center|
Documents provided by University of Chicago:
|Responsible Party:||University of Chicago|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
clinical trials enrollment
low health literacy