Trial Outcomes & Findings for Effect of Multi-Media Tool on Enrollment in Oncology Clinical Trials (NCT NCT02020252)
NCT ID: NCT02020252
Last Updated: 2021-03-10
Results Overview
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.
COMPLETED
120 participants
Immediately after the visit.
2021-03-10
Participant Flow
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.
Participant milestones
| Measure |
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.
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.
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|---|---|
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Overall Study
STARTED
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120
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Overall Study
COMPLETED
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120
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Multi-Media Tool on Enrollment in Oncology Clinical Trials
Baseline characteristics by cohort
| Measure |
Touchscreen Participants
n=120 Participants
Testing Interactive Technology
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
|
99 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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21 Participants
n=5 Participants
|
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Age, Continuous
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62.8 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
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Sex: Female, Male
Female
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39 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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81 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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116 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
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Race (NIH/OMB)
White
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96 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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4 Participants
n=5 Participants
|
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Region of Enrollment
United States
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120 Participants
n=5 Participants
|
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Clinical Trials Attitudes, Knowledge, and Interest
Receptivity
|
4.7 units on a scale
n=5 Participants
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Clinical Trials Attitudes, Knowledge, and Interest
Willingness
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4.1 units on a scale
n=5 Participants
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Clinical Trials Attitudes, Knowledge, and Interest
Knowledge
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3.3 units on a scale
n=5 Participants
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Clinical Trials Attitudes, Knowledge, and Interest
Positive Attitudes
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3.6 units on a scale
n=5 Participants
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Clinical Trials Attitudes, Knowledge, and Interest
Self-efficacy
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4.1 units on a scale
n=5 Participants
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PROMIS
Companionship
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56.4 T-score
STANDARD_DEVIATION 7.2 • n=5 Participants
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PROMIS
Instrumental Support
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59.5 T-score
STANDARD_DEVIATION 6.8 • n=5 Participants
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PROMIS
Physical Health
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48.4 T-score
STANDARD_DEVIATION 7.6 • n=5 Participants
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|
PROMIS
Mental Health
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46.1 T-score
STANDARD_DEVIATION 10.2 • n=5 Participants
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Health Literacy
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59.2 t-score
STANDARD_DEVIATION 8.9 • n=5 Participants
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PRIMARY outcome
Timeframe: Immediately after the visit.Population: New lung, gastric and pancreatic cancer patients.
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.
Outcome measures
| Measure |
Touchscreen Participants
n=120 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.
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.
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|---|---|
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Clinical Trials Attitudes, Knowledge, and Interest
Receptivity
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4.6 units on a scale
Interval 3.0 to 5.0
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Clinical Trials Attitudes, Knowledge, and Interest
Willingness
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3.9 units on a scale
Interval 2.0 to 5.0
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Clinical Trials Attitudes, Knowledge, and Interest
Knowledge
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4.9 units on a scale
Interval 1.0 to 6.0
|
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Clinical Trials Attitudes, Knowledge, and Interest
Positive Attitude
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3.7 units on a scale
Interval 2.6 to 4.9
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Clinical Trials Attitudes, Knowledge, and Interest
Self-Efficacy
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4.3 units on a scale
Interval 3.5 to 5.0
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SECONDARY outcome
Timeframe: Immediately after the visit.Population: A few people were not able to participate in the interviews.
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.
Outcome measures
| Measure |
Touchscreen Participants
n=109 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.
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.
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|---|---|
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Evaluate the Feasibility and Acceptability of Multi-media Technology.
Difficulty using the touchscreen-not at all, a little bit
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102 Participants
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Evaluate the Feasibility and Acceptability of Multi-media Technology.
Overall rating of screen design-very good, excellent
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73 Participants
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Evaluate the Feasibility and Acceptability of Multi-media Technology.
Have you used a computer within the past 12 mo-yes
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98 Participants
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Evaluate the Feasibility and Acceptability of Multi-media Technology.
Difficulty using the touchscreen to view the video or learning program-not at all
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99 Participants
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Evaluate the Feasibility and Acceptability of Multi-media Technology.
Overall rating of video-very good, excellent
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77 Participants
|
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Evaluate the Feasibility and Acceptability of Multi-media Technology.
Overall rating of learning program-very good, excellent
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78 Participants
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Evaluate the Feasibility and Acceptability of Multi-media Technology.
Did the video help you to better understand clinical trials-somewhat, quite a bit
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100 Participants
|
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Evaluate the Feasibility and Acceptability of Multi-media Technology.
Did the learning program (NC) help you to better understand clinical trials-somewhat, quite a bit
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94 Participants
|
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Evaluate the Feasibility and Acceptability of Multi-media Technology.
Overall rating of the amount of time you spent on this study, about right
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96 Participants
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Evaluate the Feasibility and Acceptability of Multi-media Technology.
Rate your experience participating-a little better, a lot better than expected
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61 Participants
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Evaluate the Feasibility and Acceptability of Multi-media Technology.
Have you ever used a touchscreen before-yes
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100 Participants
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SECONDARY outcome
Timeframe: About 6 months after the interview with participant.Population: The percentages are based on the population described in the row titles.
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.
Outcome measures
| Measure |
Touchscreen Participants
n=120 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.
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.
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|---|---|
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Clinical Trial Participation
Discussed clinical trials with a physician
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63 Percentage of participants
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Clinical Trial Participation
Offered a clinical trial among those who reported a discussion
|
38 Percentage of participants
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Clinical Trial Participation
Enrolled in a clinical trial among those offered a clinical trial
|
48 Percentage of participants
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Adverse Events
Touchscreen Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place