Testing a new visual consent process for cancer and Alzheimer research
Implement and Test Visual Consent Template and Process
NA · Washington University School of Medicine · NCT06804837
This study is testing a new visual consent form to see if it helps cancer and Alzheimer research patients understand and engage better in the research process.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 515 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine (other) |
| Drugs / interventions | Erlotinib |
| Locations | 3 sites (Saint Louis, Missouri and 2 other locations) |
| Trial ID | NCT06804837 on ClinicalTrials.gov |
What this trial studies
This study aims to implement and evaluate a visual consent template designed to enhance the informed consent process for patients participating in cancer and Alzheimer disease research. It will utilize a stepped wedge randomized control trial approach, where research teams will initially use standard consent methods before transitioning to the visual consent template at staggered intervals. The effectiveness of this new approach will be assessed based on its impact on patient understanding and engagement in the research process.
Who should consider this trial
Good fit: Ideal candidates are adult participants aged 18 and older who are eligible for one of the three participating trials at the involved institutions.
Not a fit: Patients who are not eligible for the participating trials or those who are unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve patient comprehension and satisfaction with the informed consent process, leading to better participation in clinical trials.
How similar studies have performed: While the approach of using visual aids in consent processes is gaining traction, this specific implementation and testing of a visual consent template is relatively novel.
Eligibility criteria
Show full 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.
Where this trial is running
Saint Louis, Missouri and 2 other locations
- Washington University School of Medicine — Saint Louis, Missouri, United States (RECRUITING)
- University of North Carolina at Chapel Hill School of Medicine — Chapel Hill, North Carolina, United States (NOT_YET_RECRUITING)
- University of Utah Huntsman Cancer Institute (HCI) — Salt Lake City, Utah, United States (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Mary Politi, Ph.D.
- Email: mpoliti@wustl.edu
- Phone: 314-747-1967
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer, Alzheimer Disease, Informed consent, Key information, Common Rule, Research ethics