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Completed

NCT Number: NCT02020252

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

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.

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Key information

Conditions

Lung Cancer Behavior Communication Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Stomach Diseases Stomach Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Testing an interactive technology in a diverse health literary population

Behavioral

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Merck Sharp & Dohme LLC
  • Northwestern University

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Dec 24, 2013
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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