TerminatedNot Applicable

Implement and Test Visual Consent Template and Process

Stopped: Insufficient funding

United States266 participantsStarted 2025-03-10

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in feasibility (FIM) of implementation (Research Staff only)

Timeframe: From baseline to end of study (estimated to be 4 months)

Change in acceptability (AIM) of implementation measures (Research Staff only)

Timeframe: From baseline to end of study (estimated to be 4 months)

Change in appropriateness (IAM) of implementation measure (Research Staff only)

Timeframe: From baseline to end of study (estimated to be 4 months)

Change in organizational willingness and ability to implement strategies (Research staff only)

Timeframe: From baseline to end of study (estimated to be 4 months)

Trial details

NCT IDNCT06804837

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-24

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