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

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT02020252
• Collaborator: Northwestern University (Other), Merck Sharp & Dohme LLC (Industry)
• Enrollment: 120
• Location: 1
• Actual Duration (Months): 60.2
• Patients Per Site Per Month: 2

Study Details

Study Description

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	Phase
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

• 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: Nov 26, 2013
• Actual Primary Completion Date: Dec 1, 2018
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm

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

Primary Outcome Measures

1. Clinical Trials Attitudes, Knowledge, and Interest [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. [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 [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago Comprehensive Cancer Center	Chicago	Illinois	United States	60637

Sponsors and Collaborators

• University of Chicago
• Northwestern University
• Merck Sharp & Dohme LLC

Investigators

• Principal Investigator: Blase Polite, MD, University of Chicago Comprehensive Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 28, 2014

More Information

Publications

None provided.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT02020252
• Other Study ID Numbers: IRB13-1233
• First Posted: Dec 24, 2013
• Last Update Posted: Mar 10, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Touchscreen Participants
Arm/Group Description	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. 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.
Period Title: Overall Study
STARTED	120
COMPLETED	120
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Touchscreen Participants
Arm/Group Description	Testing Interactive Technology
Overall Participants	120
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	99 82.5%
>=65 years	21 17.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.8 (11.7)
Sex: Female, Male (Count of Participants)
Female	39 32.5%
Male	81 67.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 2.5%
Not Hispanic or Latino	116 96.7%
Unknown or Not Reported	1 0.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	20 16.7%
White	96 80%
More than one race	0 0%
Unknown or Not Reported	4 3.3%
Region of Enrollment (Count of Participants)
United States	120 100%
Clinical Trials Attitudes, Knowledge, and Interest (units on a scale) [Mean (Full Range) ]
Receptivity	4.7
Willingness	4.1
Knowledge	3.3
Positive Attitudes	3.6
Self-efficacy	4.1
PROMIS (T-score) [Mean (Standard Deviation) ]
Companionship	56.4 (7.2)
Instrumental Support	59.5 (6.8)
Physical Health	48.4 (7.6)
Mental Health	46.1 (10.2)
Health Literacy (t-score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [t-score]	59.2 (8.9)

Outcome Measures

1. Primary Outcome

Title	Clinical Trials Attitudes, Knowledge, and Interest
Description	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.
Time Frame	Immediately after the visit.

Outcome Measure Data

Analysis Population Description

New lung, gastric and pancreatic cancer patients.

Arm/Group Title	Touchscreen Participants
Arm/Group Description	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. 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.
Measure Participants	120
Receptivity	4.6
Willingness	3.9
Knowledge	4.9
Positive Attitude	3.7
Self-Efficacy	4.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Touchscreen Participants
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.307
	Comments	This is for the receptivity sub-scale, and the comparison between pre and post-test scores.
	Method	t-test, 2 sided
	Comments	This was a paired t-test.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Touchscreen Participants
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.009
	Comments	This is for the willingness sub-scale, and the comparison between pre and posttest scores.
	Method	t-test, 2 sided
	Comments	This was a paired t-test.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Touchscreen Participants
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments	This is for knowledge sub scale, and the comparison between pre and posttest scores.
	Method	t-test, 2 sided
	Comments	A paired t-test.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Touchscreen Participants
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.004
	Comments	This is for the positive attitudes sub scale, and the comparison between pre and posttest scores.
	Method	t-test, 2 sided
	Comments	This was a paired t-test.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Touchscreen Participants
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments	This was for the self-efficacy sub scale, and the comparison between pre and posttest scores.
	Method	t-test, 2 sided
	Comments	This was a paired t-test.

2. Secondary Outcome

Title	Evaluate the Feasibility and Acceptability of Multi-media Technology.
Description	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.
Time Frame	Immediately after the visit.

Outcome Measure Data

Analysis Population Description

A few people were not able to participate in the interviews.

Arm/Group Title	Touchscreen Participants
Arm/Group Description	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. 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.
Measure Participants	109
Difficulty using the touchscreen-not at all, a little bit	102 85%
Overall rating of screen design-very good, excellent	73 60.8%
Have you used a computer within the past 12 mo-yes	98 81.7%
Have you ever used a touchscreen before-yes	100 83.3%
Difficulty using the touchscreen to view the video or learning program-not at all	99 82.5%
Overall rating of video-very good, excellent	77 64.2%
Overall rating of learning program-very good, excellent	78 65%
Did the video help you to better understand clinical trials-somewhat, quite a bit	100 83.3%
Did the learning program (NC) help you to better understand clinical trials-somewhat, quite a bit	94 78.3%
Overall rating of the amount of time you spent on this study, about right	96 80%
Rate your experience participating-a little better, a lot better than expected	61 50.8%

3. Secondary Outcome

Title	Clinical Trial Participation
Description	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.
Time Frame	About 6 months after the interview with participant.

Outcome Measure Data

Analysis Population Description

The percentages are based on the population described in the row titles.

Arm/Group Title	Touchscreen Participants
Arm/Group Description	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. 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.
Measure Participants	120
Discussed clinical trials with a physician	63 52.5%
Offered a clinical trial among those who reported a discussion	38 31.7%
Enrolled in a clinical trial among those offered a clinical trial	48 40%

Adverse Events

Time Frame	Not applicable to this study.
Adverse Event Reporting Description	Death and other serious and non-serious events were not collected.
Arm/Group Title	Touchscreen Participants
Arm/Group Description	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. 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.
All Cause Mortality
	Touchscreen Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Touchscreen Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Touchscreen Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.