Insufficient funding

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 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.

Prior to sharing, data will be redacted to strip all identifiers and strategies will be adopted to minimize risks of unauthorized disclosure of personal identifiers. Publicly available documentation will include the survey questions (including any relevant skip patterns), a codebook, univariate statistics for each variable, and study-level metadata. The codebook will include a brief description of each variable along with the question number and question text, variable name, variable label, value labels, and standard codes for missing values-including codes for non-applicable, "don't know," or prefer not to answer.

User information will be required to access data files. As part of the registration process, users must agree to the conditions of use governing access to the data, including restrictions around redistributing data, destruction of the data after analyses, immediate reporting of any disclosures, and proper acknowledgment of the data resource.

Final submission and release of the study data will occur 12 months following the end of data collection. Study data deposited will be available to the research community in perpetuity. Datasets underlying methodological publications will be shared at or prior to initial publication date.

Researchers who provide a methodologically sound plan.