Clinical Trial Finder

Implement and Test Visual Consent Template and Process

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06804837
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Washington University School of Medicine
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, U.S. Fed
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Cancer, Alzheimer Disease
Study Website: View Trial Website
Arms & Interventions

Arms

Active Comparator: Research Staff: Standard Consent

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.

Experimental: Research Staff: Visual Consent

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.

Experimental: Participants: Visual Consent

Participants will view the visual consent summary and will complete surveys with measures of knowledge, satisfaction with the information, decisional conflict, and potential covariates (i.e., demographics and health literacy).

Active Comparator: Participants: Standard Consent

Participants will view the standard consent consisting of summary text only and will complete surveys with measures of knowledge, satisfaction with the information, decisional conflict, and potential covariates (i.e., demographics and health literacy).

Interventions

Other: - Visual consent

Visual key information page

Other: - Standard consent

Summary text only

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Site Contact

Mary Politi, Ph.D.

[email protected]

314-747-1967

Chapel Hill, North Carolina

Status

Not yet recruiting

Address

University of North Carolina at Chapel Hill School of Medicine

Chapel Hill, North Carolina, 27599

Site Contact

Clara Lee, M.D., MPP, FACS

[email protected]

919-966-4446

Salt Lake City, Utah

Status

Not yet recruiting

Address

University of Utah Huntsman Cancer Institute (HCI)

Salt Lake City, Utah, 84112

Site Contact

Kimberly Kaphingst, ScD

[email protected]

801-213-5724

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