Gastric Cancer, Lung Cancer, Pancreatic Cancer
Conditions
Keywords
clinical trials enrollment, communication, low health literacy, health disparities
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.
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.
Interventions
BEHAVIORALTesting 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.
Sponsors
Northwestern University
Merck Sharp & Dohme LLC
University of Chicago
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| Touchscreen Participants Testing Interactive Technology | 120 |
| Total | 120 |
Baseline characteristics
| Characteristic | Touchscreen Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 21 Participants |
| Age, Categorical Between 18 and 65 years | 99 Participants |
| Age, Continuous | 62.8 years STANDARD_DEVIATION 11.7 |
| Clinical Trials Attitudes, Knowledge, and Interest Knowledge | 3.3 units on a scale |
| Clinical Trials Attitudes, Knowledge, and Interest Positive Attitudes | 3.6 units on a scale |
| Clinical Trials Attitudes, Knowledge, and Interest Receptivity | 4.7 units on a scale |
| Clinical Trials Attitudes, Knowledge, and Interest Self-efficacy | 4.1 units on a scale |
| Clinical Trials Attitudes, Knowledge, and Interest Willingness | 4.1 units on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 116 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Health Literacy | 59.2 t-score STANDARD_DEVIATION 8.9 |
| PROMIS Companionship | 56.4 T-score STANDARD_DEVIATION 7.2 |
| PROMIS Instrumental Support | 59.5 T-score STANDARD_DEVIATION 6.8 |
| PROMIS Mental Health | 46.1 T-score STANDARD_DEVIATION 10.2 |
| PROMIS Physical Health | 48.4 T-score STANDARD_DEVIATION 7.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 96 Participants |
| Region of Enrollment United States | 120 Participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: Immediately after the visit.
Population: New lung, gastric and pancreatic cancer patients.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Touchscreen Participants | Clinical Trials Attitudes, Knowledge, and Interest | Receptivity | 4.6 units on a scale |
| Touchscreen Participants | Clinical Trials Attitudes, Knowledge, and Interest | Willingness | 3.9 units on a scale |
| Touchscreen Participants | Clinical Trials Attitudes, Knowledge, and Interest | Knowledge | 4.9 units on a scale |
| Touchscreen Participants | Clinical Trials Attitudes, Knowledge, and Interest | Positive Attitude | 3.7 units on a scale |
| Touchscreen Participants | Clinical Trials Attitudes, Knowledge, and Interest | Self-Efficacy | 4.3 units on a scale |
p-value: 0.307t-test, 2 sided
p-value: 0.009t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.004t-test, 2 sided
p-value: <0.001t-test, 2 sided
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.
Time frame: About 6 months after the interview with participant.
Population: The percentages are based on the population described in the row titles.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Touchscreen Participants | Clinical Trial Participation | Discussed clinical trials with a physician | 63 Percentage of participants |
| Touchscreen Participants | Clinical Trial Participation | Offered a clinical trial among those who reported a discussion | 38 Percentage of participants |
| Touchscreen Participants | Clinical Trial Participation | Enrolled in a clinical trial among those offered a clinical trial | 48 Percentage of participants |
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.
Time frame: Immediately after the visit.
Population: A few people were not able to participate in the interviews.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Touchscreen Participants | Evaluate the Feasibility and Acceptability of Multi-media Technology. | Difficulty using the touchscreen-not at all, a little bit | 102 Participants |
| Touchscreen Participants | Evaluate the Feasibility and Acceptability of Multi-media Technology. | Overall rating of screen design-very good, excellent | 73 Participants |
| Touchscreen Participants | Evaluate the Feasibility and Acceptability of Multi-media Technology. | Have you used a computer within the past 12 mo-yes | 98 Participants |
| Touchscreen Participants | Evaluate the Feasibility and Acceptability of Multi-media Technology. | Have you ever used a touchscreen before-yes | 100 Participants |
| Touchscreen Participants | Evaluate the Feasibility and Acceptability of Multi-media Technology. | Difficulty using the touchscreen to view the video or learning program-not at all | 99 Participants |
| Touchscreen Participants | Evaluate the Feasibility and Acceptability of Multi-media Technology. | Overall rating of video-very good, excellent | 77 Participants |
| Touchscreen Participants | Evaluate the Feasibility and Acceptability of Multi-media Technology. | Overall rating of learning program-very good, excellent | 78 Participants |
| Touchscreen Participants | Evaluate the Feasibility and Acceptability of Multi-media Technology. | Did the video help you to better understand clinical trials-somewhat, quite a bit | 100 Participants |
| Touchscreen Participants | 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 | 94 Participants |
| Touchscreen Participants | Evaluate the Feasibility and Acceptability of Multi-media Technology. | Overall rating of the amount of time you spent on this study, about right | 96 Participants |
| Touchscreen Participants | Evaluate the Feasibility and Acceptability of Multi-media Technology. | Rate your experience participating-a little better, a lot better than expected | 61 Participants |