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Implement and Test Visual Consent Template and Process

TerminatedNA

Sponsor: Washington University School of Medicine

Conditions: Cancer, Alzheimer Disease

Interventions: Visual consent, Standard consent

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (3)

St Louis, Missouri, United States
Chapel Hill, North Carolina, United States
Salt Lake City, Utah, United States