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| Name | Class |
|---|---|
| Northwestern University | OTHER |
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after the visit. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after the visit. |
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Inclusion Criteria:
There are no Exclusion Criteria.
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Patients at the University of Chicago Medical Center
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| Name | Affiliation | Role |
|---|---|---|
| Blase Polite, MD | University of Chicago Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30811591 | Result | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Touchscreen Participants | Testing Interactive Technology |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Self-reported age |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | New lung, gastric and pancreatic cancer patients. | Posted | Mean | Full Range | units on a scale | Immediately after the visit. |
|
Not applicable to this study.
Death and other serious and non-serious events were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Toni M Cipriano | University of Chicago Medicine | 574-339-0652 | tcipriano@uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 28, 2014 | Jun 4, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D013274 | Stomach Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D003142 | Communication |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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. | About 6 months after the interview with participant. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Clinical Trials Attitudes, Knowledge, and Interest | 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. | Mean | Full Range | units on a scale |
|
| PROMIS | PROMIS Companionship Short Form, v2.0 - 6 items. PROMIS Instrumental Support Short Form, v2.0 - 6 items. PROMIS Global Health, v1.1 - 10 items assess overall health status (2 subscales: physical and mental health). All PROMIS measures are standardized so that a score of 50 (standard deviation of 10) represents the mean (and standard deviation) of the general U.S. population. A higher score denotes more support or better health. | Mean | Standard Deviation | T-score |
|
| Health Literacy | Health LiTT - The Health Literacy Assessment Using Talking Touchscreen Technology (Health LiTT) is a novel, self-administered multi-media test that meets psychometric standards (reliability of 0.90 or higher) for measurement of individual respondents, especially in the low to middle range of health literacy. Scores are standardized so that 50 (10) represents the mean (standard deviation) of the validation sample. A high score indicates better/high health literacy. | Mean | Standard Deviation | t-score |
|
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.
|
|
|
| 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. | A few people were not able to participate in the interviews. | Posted | Count of Participants | Participants | Immediately after the visit. |
|
|
|
| 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. | The percentages are based on the population described in the row titles. | Posted | Number | Percentage of participants | About 6 months after the interview with participant. |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
|
| Have you ever used a touchscreen before-yes |
|
| Difficulty using the touchscreen to view the video or learning program-not at all |
|
| Overall rating of video-very good, excellent |
|
| Overall rating of learning program-very good, excellent |
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| Did the video help you to better understand clinical trials-somewhat, quite a bit |
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| Did the learning program (NC) help you to better understand clinical trials-somewhat, quite a bit |
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| Overall rating of the amount of time you spent on this study, about right |
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| Rate your experience participating-a little better, a lot better than expected |
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| Enrolled in a clinical trial among those offered a clinical trial |
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