Lung CancerNCT02020252

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

An observational study of Lung Cancer and Gastric Cancer, run by University of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer, Gastric Cancer, Pancreatic Cancer
What is being tested?: Testing an interactive technology in a diverse health literary population
Type of treatment: Lifestyle or therapy programme
How many people: 120 participants
Where: 1 siteUnited States
Study dates: 26 Nov 2013to Dec 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients at the University of Chicago Medical Center

Who may be able to join

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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Lung Cancer, Gastric Cancer, Pancreatic Cancer
Being tested: Testing an interactive technology in a diverse health literary population
Keywords: clinical trials enrollment, communication, low health literacy, health disparities
Medical subject headings: Lung Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Testing an interactive technology in a diverse health literary populationBehavioural
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.

Study groups in NCT02020252
Study group	Role	What they receive
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. Receives: Behavioral: Testing an interactive technology in a diverse health literary population

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Immediately after the visit.

Secondary outcomes (2)

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.
Measured: Immediately after the visit.
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.
Measured: About 6 months after the interview with participant.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Nov 2013Dec 2018

First posted24 Dec 2013 (estimated)
Study start26 Nov 2013
Primary completionDec 2018
Study completionDec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lung CancerStudies of the same condition, open and under way.
More trials run by University of ChicagoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02020252
Sponsor's protocol ID: IRB13-1233
Status last verified: Mar 2021
First submitted: 9 Dec 2013
Last updated: 10 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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 diverse health literacy skills. Cancer. 2019 Jun 15;125(12):2066-2075. doi: 10.1002/cncr.31991. Epub 2019 Feb 27.
PubMed 30811591

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02020252
Acronym / sponsor ID: IRB13-1233
Conditions: Lung Cancer, Gastric Cancer, Pancreatic Cancer
Keywords: clinical trials enrollment, communication, low health literacy, health disparities
Study type: Observational
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: University of ChicagoUniversity, hospital or other
Collaborators: Northwestern University, Merck Sharp & Dohme LLC
Study start: 26 Nov 2013 (actual)
Primary completion: Dec 2018 (actual)
Study completion: Dec 2018 (actual)
First posted: 24 Dec 2013 (estimated)
Results: Posted 10 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Touchscreen Participants	–	Behavioral: Testing an interactive technology in a diverse health literary populationNew 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients at the University of Chicago Medical Center

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Testing an interactive technology in a diverse health literary populationEnrollment 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.	Behavioural	Touchscreen Participants

Primary outcome

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.

2 secondary outcomes

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

Results and safety

Results posted to the registry on 10 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Touchscreen Participants	120	120

Primary outcome: Clinical Trials Attitudes, Knowledge, and Interest

Time frame: Immediately after the visit.. Mean (Full Range). Unit: units on a scale

Measure	Touchscreen Participants n = 120
Receptivity	4.6 (3 to 5)
Willingness	3.9 (2 to 5)
Knowledge	4.9 (1 to 6)
Positive Attitude	3.7 (2.6 to 4.9)
Self-Efficacy	4.3 (3.5 to 5)

Touchscreen Participants: p = .307, t-test, 2 sided
Touchscreen Participants: p = .009, t-test, 2 sided
Touchscreen Participants: p <.001, t-test, 2 sided

Population analysed: New lung, gastric and pancreatic cancer patients.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Not applicable to this study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Touchscreen Participants	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 30811591Polite 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 diverse health literacy skills. Cancer. 2019 Jun 15;125(12):2066-2075. doi: 10.1002/cncr.31991. Epub 2019 Feb 27.
Individual participant dataSharing planned: No

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Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
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Active, not recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Blase Polite, MD principal investigator

University of Chicago Comprehensive Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer and Gastric Cancer, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Trials Attitudes, Knowledge, and Interest (time frame: Immediately after the visit.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02020252, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.