Clinical trial · Interventional
Implement and Test Visual Consent Template and Process
NCT06804837CI-TRIAL-00113459terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient funding
Summary
Brief summary (as posted)
The investigators plan to conduct a stepped wedge randomized control trial to implement and test the consent template and process in three studies. Randomization will occur at the research coordinator/research team level. Each participating research team member will begin in the standard consent arm of the study. Subsequently, they will be randomized to the visual key information page arm at staggered time points to undergo training and begin using the visual key information page with patients who are eligible for the selected research study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alzheimer Disease | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard consent | Other | — | UNRESOLVED |
| Visual consent | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Research Staff: Standard Consent
- description
- Each participating research team member will begin in the standard consent arm of the study. The standard consent consists of a summary using text only.
- interventionNames
- Other: Standard consent
- type
- EXPERIMENTAL
- label
- Research Staff: Visual Consent
- description
- After beginning in the standard consent arm, the research staff will then be randomized to the visual key information page arm at staggered time points to undergo training and begin using the visual key information page with patients who are eligible for the selected research study. Research staff will also complete a baseline survey to assess feasibility, acceptability, and appropriateness of using visual consent pages as well as their institution's willingness and ability to implement using visual key information pages into routine care. Research staff will also complete a post-study survey on attitudes toward consent, the intervention (feasibility, acceptability, appropriateness of the intervention), organizational readiness for participant engagement, and willingness to continue the invention.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Eligibility Criteria for Patients:
* Adult participants (18+) eligible for one of three participating trials at Washington University, University of Utah, or University of North Carolina at Chapel Hill. The eligibility criteria for the main trials are below:
* UNC:
* Basal-like PDAC Treated with Gemcitabine, Erlotinib, and Nab-paclitaxel (PANGEA) trial inclusion criteria:
* Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information.
* Participant is willing and able to comply with study procedures based on the judgment of the investigator.
* Age ≥ 18 years at the time of consent.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
* Consent to a mandatory pre-study biopsy if archival tissue is not available or sufficient.
* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen.
* Washington University:
* Returning Research Results That Indicate Risk of Alzheimer Disease Dementia to Healthy Participants in Longitudinal Studies (WeSHARE)
* Participants of the Knight Alzheimer Disease Research Center.
* Participants with available results from an Alzheimer Disease blood biomarker test.
* Participants who agreed to be contacted for additional research studies.
* University of Utah:
* Huntsman Cancer Institute Total Cancer Care
* Participants who have been diagnosed with any type of tumor or cancer.
* Participants with genetic predispositions or family history of cancer or tumors.
* Participant volunteers willing to share samples and data for research.
Eligibility Criteria for Research Staff:
* Research staff/coordinators of one of the three participating trials at Washington University, University of Utah, or University of North Carolina at Chapel Hill.References
Publications (2)
- DERIVEDPoliti MC, Lee CN, Goldstein EC, Cooksey KE, Mozersky J, Housten AJ, Lu J, Wu S, Volkmar M, Catalan-Gallegos V, Kaphingst KA. Evaluating Whether Icons and Visual Elements Help or Hinder Understanding of Key Information for Research Studies: Results From a Randomized Trial. Health Lit Res Pract. 2026 Apr;10(2):e44-e51. doi: 10.3928/24748307-20260309-02. Epub 2026 May 1. PMID 42065932
- DERIVEDCooksey KE, Goldstein EC, Lee CN, Mozersky J, Kaphingst KA, Liu J, Wu S, Volkmar M, Catalan-Gallegos V, Politi MC. Implementing and evaluating visual key information pages compared to text-based key information: protocol for a stepped-wedge cluster randomized trial. BMC Med Ethics. 2025 Nov 29;27(1):1. doi: 10.1186/s12910-025-01341-y. PMID 41318540