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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02020252
Other study ID # IRB13-1233
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 26, 2013
Est. completion date December 2018

Study information

Verified date March 2021
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Chicago Comprehensive Cancer Center Chicago Illinois

Sponsors (3)

Lead Sponsor Collaborator
University of Chicago Merck Sharp & Dohme Corp., Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Polite BN, Cipriano-Steffens TM, Liao C, Miller EL, Arndt NL, Hahn EA. Investigation of a multimedia, computer-based approach to improve knowledge, attitudes, self-efficacy, and receptivity to cancer clinical trials among newly diagnosed patients with div — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Secondary 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.
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