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This is a study to evaluate the impact of evidence-based visual key information (VKI) pages on participant's experiences with informed consent for research, enrollment in high-accruing studies that choose to use VKIs as part of their consent process, and research team perceptions of the implementation potential of VKIs in studies. Unlike in previous pilots conducted at Siteman Cancer Center, this study will assess changes in outcomes before and after a VKI is implemented in a study consent process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard consent forms | Active Comparator | The approved standard consent form will be used during the consent processes. |
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| Standard consent forms with a visual key information (VKI) page | Experimental | The approved standard consent form with a VKI page will be used during the consent processes. |
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| Research Team Members | Experimental | Members of the parent study's research team will complete the research team survey to assess opinions on consent process. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Consent Form | Behavioral | The IRB-approved consent form will be used by research team staff during consenting process of participants for parent studies. |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient's knowledge of consent | Knowledge of consent will be measured by patient's responses to 6-items on the patient consent experience survey. The 6-items are customized for each parent study and have three answers for patient to choose: true, false, and unsure. Responses will be reported via descriptive statistics and between group differences will be examined via chi-square tests. | Time of consent completion for parent study (day 1) |
| Patient's anxiety about enrolling | Anxiety about enrolling will be captured by patient's answers to a single item on the patient consent experience survey adapted from the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The item is measured by a 5-point Likert scale as follows: Not at all, A little, Somewhat, A lot, and Extremely. Responses be will scored as appropriate for the validated measure and between group differences will be examined via t-tests. | Time of consent completion for parent study (day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's trust in information | Patient's trust in information will be measured by a single-item on the patient consent experience survey adapted from the Health Information National Trends Survey (HINTS) from the National Cancer Institute. The item is a 5-point scale with answers as follows: Not at all, Slightly, Moderately, Very, and Extremely. Responses will be scored as appropriate for the validated measure and between group differences will be examined via t-tests. |
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Patient Eligibility Criteria:
Research Team Eligibility Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary C Politi, PhD | Washington University in St. Louis School of Public Health | Principal Investigator |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004591 | Electrophoresis, Polyacrylamide Gel |
| ID | Term |
|---|---|
| D004586 | Electrophoresis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D055664 | Electrochemical Techniques |
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| Visual Key Information (VKI) page | Behavioral | A VKI page will be designed for each parent study based on study materials and current consent document. The VKI will be implemented in the consent material for the study. |
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| Time of consent completion for parent study (day 1) |
| Patient's perceptions of patient centered care | Perception of patient-centered care (PCC) will be measured by three items on the patient consent experience survey which are adapted from the Health Information National Trends Survey (HINTS) from the National Cancer Institute. The items are a 4-point scale as follows: Always, Usually, Sometimes, and Never. Responses will be scored as appropriate for the validated measure and between group differences will be examined via t-tests. | Time of consent completion for parent study (day 1) |
| Parent study enrollment rates | Enrollment rates will be measured by total number of patients enrolled in each parent study. Responses will be reported via descriptive statistics and between group differences will be examined via t-tests. | Completion of enrollment (estimated total time is 9-13 months) |