AzTrials
AzTrials

CancerNCT06804837

Implement and Test Visual Consent Template and Process

A study testing Visual consent and Standard consent in people with Cancer and Alzheimer Disease, run by Washington University School of Medicine at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cancer, Alzheimer Disease
What is being tested?
Visual consent and Standard consent
Could I receive a placebo?
No, everyone receives an active treatment
How many people
266 participants
Where
3 sitesUnited States
Study dates
10 Mar 2025to 24 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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 locations and contacts

3 sites in 1 country.

United States3 sites

  • University of North Carolina at Chapel Hill School of Medicine

    Chapel Hill, North Carolina, 27599

  • University of Utah Huntsman Cancer Institute (HCI)

    Salt Lake City, Utah, 84112

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

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.

Being tested
Visual consent, Standard consent
Keywords
Informed consent, Key information, Common Rule, Research ethics
Medical subject headings
Neoplasms, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Visual consentOther

    Visual key information page

  • Standard consentOther

    Summary text only

Study groups in NCT06804837
Study groupRoleWhat they receive
Research Staff: Standard ConsentActive comparatorEach participating research team member will begin in the standard consent arm of the study. The standard consent consists of a summary using text only.
Receives: Other: Standard consent
Research Staff: Visual ConsentExperimentalAfter 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.
Receives: Other: Visual consent
Participants: Visual ConsentExperimentalParticipants 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).
Receives: Other: Visual consent
Participants: Standard ConsentActive comparatorParticipants 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).
Receives: Other: Standard consent

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    4 items on a Likert scale ranging from completely disagree to completely agree. Higher scores indicate greater feasibility. (1=completely disagree, 3= neither agree nor disagree, 5= completely agree)

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

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

    4 items on a Likert scale ranging from completely disagree to completely agree. Higher scores indicate greater acceptability. (1=completely disagree, 3= neither agree nor disagree, 5= completely agree)

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

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

    4 items on a Likert scale ranging from completely disagree to completely agree. Higher scores indicate greater appropriateness. (1=completely disagree, 3= neither agree nor disagree, 5= completely agree)

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

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

    Measure of organizational readiness for engagement (MORE) measure; 4-point scale (1=not willing, 4=; willing) report mean and SD; higher scores indicate higher level of readiness

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

Secondary outcomes (4)

  1. Knowledge of information provided in the consent (Participant only)

    The investigators will ask up to7 true/false/unsure questions. Missing responses will be considered false/incorrect. An overall knowledge score will be calculated with the percentage of items correctly answered. Higher scores indicate greater participant understanding of the clinical trial.

    Measured: At time of consent review (day 1)

  2. Satisfaction of information provided in the consent (Participant only)

    NIH Health Information National Trends Survey (HINTS); 5-items on a Likert scale (1=completely disagree, 3= neither agree nor disagree, 5= completely agree). Higher scores indicate higher satisfaction.

    Measured: At time of consent review (day 1)

  3. Decisional conflict (Participant only)

    SURE measure; 4-item measure. Scores less than equal to 3 indicate the presence of decisional conflict

    Measured: At time of consent review (day 1)

  4. Number of enrollments to clinical trials (Participant only)

    The investigators will document whether or not participants enroll in the trials.

    Measured: At time of consent review (day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2025
  2. Study start10 Mar 2025
  3. Primary completion24 Apr 2026
  4. Study completion24 Apr 2026

Why it stopped: Insufficient funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Sequential
Model description
This is 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.
Masking
None (open label)
Enrolment
266 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06804837
Sponsor's protocol ID
202501068
Other IDs
R01HS029310
Status last verified
May 2026
First submitted
27 Jan 2025
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Politi 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.

    PubMed 42065932

  • Cooksey 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.

    PubMed 41318540

Questions about this trial

What is this clinical trial studying?

A study testing Visual consent and Standard consent in people with Cancer and Alzheimer Disease, run by Washington University School of Medicine at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Insufficient funding). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in feasibility (FIM) of implementation (Research Staff only) (time frame: From baseline to end of study (estimated to be 4 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06804837, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Implement and Test Visual Consent Template and Process | AzTrials